cyrilzakka/clinical-trials huggingface dataset:
Etamine Processing on Episiotomy Repair Skills, Stress and Learning Attitudes in Midwifery Students

Research Hypotheses H1: Midwifery students who practice Etamine have higher episiotomy repair skills than those who do not.

H2: Midwifery students who practice Etamine have lower perceived stress levels than those who do not.

H3: Midwifery students who practice Etamine have higher learning attitudes than those who do not.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study include students who are willing to participate in the study and who do not have any learning or working experience related to episiotomy repair.

Exclusion Criteria:

* Students with diagnosable diseases affecting their learning ability, those who have had accidents during the training and assessment sessions, and foreign nationals will be excluded from the study.
Contrast Sensitivity in Glaucoma

The primary aim of the Erlangen´s Glaucoma Contrast Sensitivity-Study (EGCS-Study) is the evaluation of the diagnostic and prognostic validity of a diagnostic procedure, measuring contrast sensitivity. No therapeutic studies are performed.


Eligibility Criteria:
* Patients: Primary open angle glaucoma, secondary open angle glaucoma due to PEX
* Healthy volunteers (for reliability analysis)

Inclusion Criteria:

* Age \> 18
* Best corrected visual acuity 0.8 or better
* European

Exclusion Criteria:

* eye diseases: Infantile glaucoma, angle glaucoma, secondary open angle glaucoma, wich are not due to PEX, diseases involving retina, condition after ophthalmological operations or trauma, cataract, diseases concerning the refractive system, age-related macular degeneration, diabetic retinopathy, optic neuropathy (MS, neuritis), amblyopia
* Any neurological diseases
* Systemic diseases with potentially ocular involvement (e.g., diabetes mellitus)
* Systemic drugs with potentially ocular involvement
* ocular drugs
Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk

A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer.

Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to:

1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or
2. Yearly MRI.

Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 40-59 years with
* cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). The lifetime cumulative risk of breast cancer will be computed using the IBIS Breast Cancer Risk Evaluation Tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. The evaluation of the composition of the mammary gland will be performed using the BI-RADS classification. Women with mammography in class 4 (i.e., \>75% of glandular component) will be eligible for randomization.
* Written Informed consent

Exclusion Criteria:

* Signs or symptoms of breast cancer at enrolment;
* Previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
* BRCA or p53 mutation carrier status;
* General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
* Contraindications to any intravenous administration of contrast agent;
* Ongoing or planned pregnancy (for the duration of the study);
* Hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
* Presence of breast implants;
* Previous diagnosis of cancer at any site;
* Life-threatening diseases;
* Mental disability precluding informed consent to participate
Clinical Intelligent Management System Pragmatic RCT

This study aims to evaluate the effectiveness of a clinical intelligent management system, based on a multimodal foundational model, in improving the quality of primary care at a community health service center.

Using a prospective, randomized controlled, single-blind study design, the trial will include primary care physicians and adult patients seeking care at the Tiantongyuanbei Community Health Service Center and Shanghai Health and Medical Center.

Physicians in the intervention group will utilize the intelligent management system with AR glasses to aid in diagnosis and treatment, while patients will engage with the system's patient interface to access health education, follow-up reminders, and AI-powered home consultation features. In contrast, physicians in the control group will provide routine diagnoses and treatments, with their patients receiving standard health education and follow-up care. The trial was designed with the assistance of a digital twin-based clinical research system (termed X Town).

By comprehensively evaluating diagnostic quality, physicians' clinical abilities, patient-reported outcomes, and system appraisals, this study will assess the effectiveness of the clinical intelligent management system in enhancing the quality of primary care and patient management.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Receiving care at a community health service center
* Able to understand and comply with the study procedures
* Agrees to participate in the study and signs the informed consent form

Exclusion Criteria:

* Patients with severe mental illness
* Patients unable to independently complete the questionnaire
* Patients expected to be unable to complete follow-ups within three months
mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Eligibility Criteria:
Inclusion Criteria:

* Patients have provided a signed Informed Consent Form
* ECOG performance status of 0-1
* BMI ≥ 18.5
* Age: 18-65 years old
* Histologically confirmed diagnosis of metastatic pancreatic cancer
* No prior palliative chemotherapy
* Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* Patient has adequate bone marrow and organ function

  * Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
  * Platelets ≥ 90 x 109/L
  * Hemoglobin ≥ 90 g/L
* Patient has adequate liver function

  * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  * Serum bilirubin ≤ 1.2 x ULN
* Creatinine ≤ 1.25 times ULN
* Good compliance

Exclusion Criteria:

* Pregnant or lactating women
* Brain metastasis or only with bone metastasis.
* Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
* Refuse to take appropriate contraceptive measures (including male patients).
* Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
* Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
* Psychiatric illness that would prevent the patient from giving informed consent.
* Patient is concurrently using other antineoplastic agent
* Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
* Known HIV-positivity.
* No history of chronic diarrhea, nausea or vomit.
* No ≥ grade 2 sensory peripheral neuropathy.
* A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
* Infectious disease or inflammation with body temperature ≥ 38 ℃.
Inflammation, Platelets and Sickle Cell Disease

Sickle cell disease (SCD) is an autosomal recessive genetic disorder linked to a single mutation on beta-globin chains. This leads to red blood cell deformation and chronic hemolysis which can result in vaso-occlusive events, anemia and vasculopathy. Pathophysiology is incompletely understood, and beyond red blood cell's abnormalities this involves hemostasis and innate immunity. The aim of our study is to describe the mechanisms of thrombo-inflammation during the vaso-occlusive crisis (VOC) in adults with sickle cell disease.

Pathophysiology of sickle cell disease is incompletely understood. The typical change of red blood cells into sickle cells lead to post-capillary stream abnormalities. This phenomenon is responsible of ischemia-reperfusion injuries. Chronic hemolysis is the second part of the pathophysiology. The consequences are vasoconstriction, endothelial lesions, chronic inflammation, hemostasis and platelets activation. Thrombo-inflammation concept was proposed by Tanguay to describe the interactions between hemostasis, platelets and innate immune cells (neutrophils polynuclear) during thrombotic process. Since this time, this concept was largely described in many clinical situations such as septicemia, COVID-19, coronaropathy, auto-immune diseases and sickle cell disease.

In this project, we will study platelets activation and thrombo-inflammation markers in the beginning of a vaso-occlusive crisis, during the crisis and two months after the crisis. Blood samples will be collected during a routine care sample.

Biological markers studied will be:

* Soluble and surface markers of platelet activation; platelet-leukocytes aggregates
* Plasmatic eicosanoids produced by platelets (TXB2) and immune cells
* In vitro platelets reactivity; dynamic thrombus formation in normal and pathologic arterial blood stream
* Platelet's inflammasome

Eligibility Criteria:
Inclusion Criteria:

* Patient with sickle cell disease diagnosis, hospitalized in emergency department and/or internal medicine department
* Patient older than 18 years
* Written consent to participate to the study
* Patient with health insurance
* Patient able to receive information about the study

Exclusion Criteria:

* Age \< 18 years
* Non consent to participate to the study
* Women in pregnancy or breastfeeding
* Treatment with aspirin or non steroidal anti inflammatory drug
* Protected patient
* Patient already involved in a study requiring collection of additional biological samples
Impact of Adding Midzolam to Bupavicaine 0.5% in Regional Spinal Anaesthesia on Maternal Middle Cerebral Artery Velocimetry in Parturients With Severer Preeclampsia

Trial to use GABA mimetic action of midazolam to ameliorate the severe preeclampsia induced neuronal excitotoxicity using middle cerebral artery transcranial doppler resisitive vasculer indices to evaluate . Secondery goal is to study end organ injury


Eligibility Criteria:
Inclusion Criteria:

* All parturients with severe preeclampsia for urgent C.S

Exclusion Criteria:

* Ladies refusal to participate. Refusal to have spinal anesthsia
Academic Detailing About Proton Pump Inhibitors

General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either proton pump inhibitor (intervention) or another topic (control).

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

General practices in the Capital Region of Denmark are offered a short educational visit. They are randomized by address to be offered a visit about either proton pump inhibitor (intervention) or another topic (control).

The prescription pattern of each general practice (as seen by their regional registration number \[ydernummer\]) who receive a visit is investigated.

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

* General practices in the Capital Region of Denmark, who owns a regional registration number \[ydernummer\]
* Want a visit
* Have time for a visit within the study period

Exclusion Criteria:

-
Co-Sér: Serological Analysis and Viral Neutralization in People With a Documented COVID-19 Infection

In light of the current coronavirus disease 2019 (COVID-19) pandemic, the investigators want to better study the immunological characteristics of Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) infections in adults. The investigators invite volunteers to participate in a clinical study to better understand what happens after an infection with SARS-CoV2. By collecting and analysing blood samples of people that were infected, the investigators want to evaluate whether or not the participants had an adaptive immune response with the producting of immunoglobulin. The investigators will evaluate the quality of the antibodies and their neutralising capacity. In a selected patient group with strong antibody response, the investigators will try to reproduce them in the lab after the collection of a larger blood sample (max 72 mL) of, in case of insufficient B-cells, a leucapheresis (after consent of the patient). These antibodies can be used in clinical trials to evaluate whether the investigators can cure patients faster or prevent disease by the utilisation of these antibodies.

Aside from the aforementioned information the investigators will also collect clinical data such as: demographic information, medical history, routine lab results, radiographic imaging and medication use.

After the completion of the study, the samples will be stored for 30 years with consent of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of prior COVID-19 infection, documented by polymerase chain reaction (PCR) or antibody testing (IgG based)

Exclusion Criteria:

* Known pregnancy at the time of screening
* Patient is on immunosuppressive therapy or was treated with immunosuppressive therapy during the last 6 months
* Inability to give informed consent or absence of legal representative who can give informed consent.
Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects

The purpose of this study is to collect information about how a doctor uses the results of the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients. Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes may help doctors to better treat NSCLC in the future. This study will also look to establish whether new investigational tests can help better predict the effectiveness of certain medications for certain patients. These new investigational tests are only for research purposes at this time.

The primary purpose of this observational study is to assess the physician's clinical practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational status. This study will also attempt to further validate that VeriStrat test results stratify subjects by clinical outcomes in the real world, uncontrolled clinical setting while exploring whether certain therapeutic approaches may yield opportunities for further study.

Predictive tests that aid physician therapeutic decision making are critical for optimizing subject outcomes while minimizing toxicity and associated treatment costs. This study will provide data for the validation of immunotherapy tests currently being developed. Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor microenvironment, and the patient immune system. As such, a successful predictive test will reflect the complex interplay between tumor and host. The multivariate tests from Biodesix have the advantage of being able to assess this complex biology.

The information gained from this research will not only guide the adoption of the VeriStrat test and inform medical decision making, including treatment choice, but will allow the validation of additional mass-spectrometry-based proteomic tests.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 years of age or older at time of signing informed consent form (ICF).
2. A diagnosis of NSCLC.
3. Subject is willing to provide serum samples for VeriStrat testing.
4. EGFR mutation status wild-type (negative) or a tested unknown.
5. For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
6. Subject is willing to provide serum samples for research, understanding that no test results will be made available either to the subject or the treating physician.
7. Subject is able to read and understand the ICF and agrees to comply with study procedures and requirements.

Exclusion Criteria:

1. Subject's ability to understand the requirements of the protocol or to provide informed consent is impaired or subject is unwilling to comply with the protocol requirements.
Prevalence of Psychiatric Disorders in the Refugee Population of Turkey

The investigators are planning to diagnose psychiatric disorders in willing participants from the refugee population in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Having official refugee status in Turkey, willing to participate in the study

Exclusion Criteria:

* Having any disability that prevents answering interviewers' questions
IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic

The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.

Determine the need for systematic outpatient prescription of NSAI.

Renal colic are a frequent cause of consultation in the emergency departement (ED).

They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.

For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.

But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.

the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.

In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.

Eligibility Criteria:
Inclusion Criteria:

* Over 16 years old
* Consenting to participate in the study
* Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
* VAS\> 50% at consultation

Exclusion Criteria:

* Inability to assess pain VAS;
* Pregnant or lactating woman;
* Recognized renal disease (glomerular filtration rate \<60ml/kg/1.73m2);
* Known hepatic insufficiency;
* Known or suspected allergy to NSAIDs, morphine
* Peptic ulcer known;
A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy

The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients.

A parallel group double blind study design has been selected. The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided written informed consent
2. Male or female subjects ≥ 18 years of age
3. Subjects prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of radiation as judged by the CI or PI during the radiotherapy planning process

Exclusion Criteria:

1. Subject is pregnant or breastfeeding
2. Subjects with known allergies to egg, soya, or lanolin (sheep's wool grease) based products
3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögren's syndrome) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
4. Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent
5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI)
6. Subjects who are unable to independently complete the questionnaire or diary
7. Subjects who are judged inappropriate for inclusion in the study by the CI or PI
8. Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion