cyrilzakka/clinical-trials huggingface dataset:
Storage Temperature and Quality of Leucoreduced Whole Blood

In a combat situation the need for safe and high-quality blood products is increasing. WB (Whole Blood) is used in many trauma situations, but we wish to investigate whether there is an even better whole blood product.

The purpose of this study is to examine the quality of leucoreduced, cold-stored whole blood. We also wish to examine the effects of filtration of whole blood without a 1-2 hour holding-time (warm-filtration) and the effects of forced filtration. We also wish to explore the possibility of using cold-stored WB for production of RCC.

Analyses are performed with a main focus to investigate function and quality of red blood cells and platelets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Age between 18 and 70
* Negative pregnancy test (women in fertile age)
* Blood pressure range: (160-100)/(100-40)
* Pulse range: 40-100

Exclusion Criteria:

* Usage of platelet-influencing medication
* Mild flu or more severe illnesses
* Open wound
* Pregnancy or trying to get pregnant
Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

This clinical trial is divided into two main phases:

I. The first one involves the construction of better image processing algorithm from a learning sample. The learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled.

II. The second one, will evaluate from an evaluation sample, the diagnostic performance of the test VisioCyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. The evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient affiliated to a social security system
* Patient able to understand the protocol.
* Signature of patient consent form before the start of the study
* Negative urine culture
* Patient for which is programmed a bladder Endoscopy for :

  * suspected bladder cancer (de novo, monitoring or relapse)
  * Exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer

Exclusion Criteria:

* Age \<18 years
* Ongoing Urinary tract infection untreated
* Private person of liberty or under guardianship (including guardianship)
* Bladder cancer excluding urothelial carcinoma
* Carcinoma of high urinary tract, associated
* Lithiasis pathology
* Patient who underwent renal transplantation
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo

Eligibility Criteria:
Inclusion Criteria

1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
2. Birth weight ≥ 500g
3. Singleton or twin birth

Exclusion Criteria

1. Complete enteral feeding
Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research

The study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.


Eligibility Criteria:
Inclusion Criteria:

* Participants willing and able to provide written informed consent
* Participants are willing and able to provide appropriate photo identification
* Participant's age 18 - 100 years old
* Participants diagnosed with active non-small cell lung cancer (Adenocarcinoma or Squamous Cell only. All stages are acceptable.)
* Participants must have associated tissue biomarker data (EFGR and MET mutations) in their medical records

Exclusion Criteria:

* Participants who are pregnant or nursing
* Participants with a known history of HIV, hepatitis, or other infectious diseases
* Participants who have taken an investigational product in the last 30 days
* Participants who have experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the previous two months
* Participants currently enrolled in a clinical trial
* Participants currently in remission
Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment

The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are 18 years of age or older.
* Are HIV-positive.
* Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
* Have had more than 12 weeks of prior anti-HIV drug treatment.
* Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
* Are responsive to Agenerase.
* Are able to follow study requirements.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are intolerant to ritonavir (an anti-HIV drug).
* Have or have had problems with absorption.
* Have liver disease or damage.
* Have pancreatic disease or damage.
* Have taken any protease inhibitor other than nelfinavir.
* Are receiving investigational drugs or devices from another study.
* Are pregnant or breast-feeding.
* Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
* Have a bleeding disorder.
* Have previously been treated with Agenerase.
* Are receiving nonnucleosides.
Malnutrition Associated With Complications After Ileostomy Reversal

An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible. Ileostomy closure involves reconnecting the ileum to the remaining colon, allowing normal bowel movements again. This study will look at the outcomes of these surgeries in patients who were seen and operated on by the investigators.

This study focused on outcomes and complications after ileostomy closure. An ileostomy is a surgical opening established by bringing the end or a loop of the ileum to discharge directly outside the body. This is typically done when part or the entire colon is removed because of IBD, cancer, or familial adenomatous polyposis. Reversal of this procedure, an ileostomy closure, may be done if possible to reconnect the ileum to the remaining colon and allow normal bowel movements again. This study looked at the outcomes for these surgeries in patients who were seen and operated on by the investigators. Patients were identified from the files and schedules of the investigators, and Epic was used to collect the information needed to determine perioperative clinical characteristics and post-operative outcomes. This data was kept in a secure electronic database, with identifiers removed as soon as all of the data was collected for a patient.

Eligibility Criteria:
Inclusion Criteria:

* ileostomy closure procedure

Exclusion Criteria:

* none
DeFRA Questionnaire as an Anamnestic Form

The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population never screened before and never treated for this disease.

There is an increasing recognition that the management of osteoporosis requires the characterization of fracture risk to be based on absolute risk rather than single measures such as bone mineral density (BMD). However, the threshold for pharmacological intervention for osteoporosis remains controversial.

The aim of the present project is to perform a large scale study to identify subjects at risk of osteoporosis by administering the DeFRA questionnaire in a population never screened or treated before for osteoporosis.

DeFRA questionnaire will be administered before and after DEXA scanning, to further validate the questionnaire and to highlight the predictive value of this protocol as a tool to screen the general population.

Eligibility Criteria:
Inclusion Criteria:

* age: 50 to 70 years
* no overt pathologies
* never screened before for osteoporosis
* no prior use of drugs for osteoporosis
* signed informed consent form

Exclusion Criteria:

* overt pathologies (cancer, neurodegenerative diseases, renal or hepatic insufficiency)
* use of the following drugs: cortisones, loop diuretics, antiepileptic drugs, aromatase inhibitors, dicoumarols, thyroxin in suppressive therapy, antiosteoporosis drugs)
* patients who underwent radiation therapy
* hypercalcemia or alterations of the phospho-calcic metabolism
* patients with metabolic diseases of the bone (including hyperparathyroidism or Paget disease)
Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment

The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. However, there are few studies investigating the reproducibility of these measures such as muscle strength, range of motion (ROM) and hip functionality in healthy subjects.

Twenty subjects were randomized in two different days: (1) First evaluation of muscle strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the first evaluation with 3 different evaluators

Eligibility Criteria:
Inclusion Criteria:

* No complaints of pain or knowledge of hip pathology
* Subjects willing to enroll

Exclusion Criteria:

* Subjects reporting that they can not perform the tests due to pain
* With previous surgery of the hip or pelvis;
* Diabetes Mellitus;
* Neuromuscular or neurological diseases;
* Cardiovascular diseases that prevent the realization of maximum voluntary effort;
* Subjects presenting positive hip clinical tests
Effect of Nursing Interventions Using Roy Adaptation Model with Virtual Reality on Social Anxiety in Youth

The study was conducted to determine the effect of nursing practices based on the RAM integrated with VR on the social anxiety level of young people.The main questions it aims to answer are:

H1: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective in reducing the level of social anxiety in young people." H2: "Nursing practices based on the Roy Adaptation Model integrated with virtual reality are effective on the level of life satisfaction, independent of anxiety level and as a predictor of social anxiety"

This single-blinded randomized controlled study utilized a pretest-posttest control group and single-blinded randomized control group, preintervention pretest, postintervention posttest, and follow-up test design. The study population consisted of students from a foreign language preparatory class at a university. In this context, the Anxiety Subdimension of the LSCQ was calculated for 785 preparatory class students aged 18-26. A total of 242 students scoring 30 and above on the Anxiety Subdimension of the LSCQ were reached. The research was completed with a sample of 72 students who met the inclusion criteria within this target group. Individuals who do not participate in two or more of the six interviews will be excluded from the study. The study\&amp;#39;s experimental design was organized according to the CONSORT guidelines

The study used virtual environments and characters based on "The Amelia VR Platform" for mental health researchers developed by Psious software company as a supportive tool in nursing interventions for social anxiety. The virtual environments included scenarios such as presentating in a large conference hall, conducting a business/office meeting with an authority figure and colleagues, presenting to a small group in a seminar hall, and socializing with friends. These environments comprehensively evaluate individuals' issues in public speaking and can also be used within the scope of a separate program to test and improve skills such as verbal communication and academic presentation. The whole process is controlled by a counselor via a computer connected to the platform. The counselor can manipulate the content, duration, and intensity of the process in a controlled manner for the purpose of the application.

Eligibility Criteria:
Inclusion Criteria:

* Liebowitz Social Anxiety Scale (LSAS) anxiety subscale score of 30 and above,
* Having not used a psychiatric drug in the last three months,
* Not having received psychotherapy for social anxiety before,
* Willingness and volunteering to participate in the research.

Exclusion Criteria:

* Active suicide risk,
* Psychotic symptoms,
* Individuals who do not participate in two or more of the six interviews will be excluded from the study.
CoreValve Advance-II Study: Prospective International Post-market Study

The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.

The purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the Medtronic CoreValve device, aiming to characterize best practices. The investigators did not assign study specific interventions to the subjects in the study.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the criteria of labeling indications of the CoreValve System;
* Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race;
* Provided Signed Informed Consent or Data Release Form.

Exclusion Criteria:

* Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator);
* Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines;
* Persistent or permanent atrial fibrillation (except paroxysmal AF);
* Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study.
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Pregnancy
Web-based Approach in Nutrition and Diabetes

The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). The study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). Anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI ≥25 kg/m2)
* Participants with or at risk of Type 2 Diabetes Mellitus
* Skills in the use web-based technologies and internet accessibility

Exclusion Criteria:

* Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.
Breast Cancer and Quality of Life

The study aims to analyse and decode interviews of patient with breast cancer, and then established according a multidimensional profile specific to the population and to create a questionnaire tha will allow a practical and qualitative evaluation of the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* age \< 45
* non metastatic breast cancer
* at least 6 months of relationship

Exclusion Criteria:

* no life partner
* inclusion criteria failure
A New Neuraxial Position Technique " The Anatolian Sitting Position- Sitting Fetal Cross-legged"

A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare "The Anatolian sitting position-ASP" with "The Sitting Fetal Position-SFP" sonographically. Secondary aim is to compare their comfort.

Fifty participants were included to this prospective, randomized, consecutive controlled clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left paraspinal muscle \[LPM\] and right paraspinal muscle \[RPM\]), interspinous gap opening (ISGO), mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via ultrasonography (USG) according to the positioning techniques (the Anatolian Sitting Position \[ASP\] could also be named as "sitting fetal cross-legged position" and the Sitting Fetal Position \[SFP\] which is a traditional sitting position) were also calculated. The calculations are explained briefly in primary outcomes (including the change of ASP-SFP in ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort (LC), and abdominal comfort (AC) were evaluated by the participants with the 5-point Numerical Rating Scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

* healty and adult volunteers,
* must be able to do the sitting fetal cross-legged position ( ASP ),
* must be able to do the sitting fetal position ( SFP ).

Exclusion Criteria:

* BMI higher than 40,
* Lumbar hernia,
* Scoliosis,
* History of spine surgery,
* History of trauma,
* History of lower back pain,
* Arthropathy {especially pelvic or knee problems},
* Could not be able to do one or both of the two neuraxial position techniques.
Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal

This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.

Patients were randomly assigned to one of four groups. All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal. Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status 1 or 2
* undergoing lower extremity surgery under general anesthesia

Exclusion Criteria:

* suspected difficult airways
* respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
* body mass index \> 30 kg/m2
* allergies to the study drugs
* a history of gastric reflux
COVID-19 Echo Study

Investigation of the cardiac manifestations of COVID-19 in patients admitted to hospital

The COVID-19 disease (caused by SARS-CoV-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (ICU) and artificial ventilation of their lungs. However, early reports from China have documented an element of injury to the heart present in up to 20% of patients. They have also documented patients who have died on ICU from heart injury rather than lung injury in COVID-19 positive patients. There are increasing numbers of reports of patients with COVID-19 having significant inflammation of the heart. What is not known is the prevalence of significant inflammation of the heart secondary to the SARS-CoV-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. That is to say is the injury significant to the outcome of the patient?

In order to investigate this, it is proposed to conduct a heart scan in COVID-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. If it is found that there is a significant amount of heart injury done by the SARS-CoV-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. Alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Positive swab or serology for COVID-19
3. Referred for echocardiographic evaluation for clinical reasons
4. Willing and able to give assent

Exclusion Criteria:

1. Known hypersensitivity to perflutren or known excipients in LUMINITY
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure

The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be ≥18 years old
* Previously untreated systolic pressure result of ≥120\<160 mmHg and diastolic pressure result of ≥80\<100 mmHg

Exclusion Criteria:

* Subjects must not have previously received any anti-hypertensive medication
* must not have a systolic pressure \<120 mmHg or ≥160 mmHg and diastolic pressure result of \<80 mmHg or ≥100 mmHg
* must not have had a previous coronary artery bypass graft (CABG)
* must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent
* must not have severe congestive heart failure (New York Heart Classification \[NYHC\] III-IV).