cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel in ICU Patients With Severe Pneumonia.

The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.

This is a prospective, observational, multicenter ICU study. Adult patients with severe pneumonia requiring invasive mechanical ventilation will be included. Severe pneumonia consists of 3 categories of pneumonia: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-acquired pneumonia (VAP). The microbiological testing will be performed before antibiotic initiation on tracheobronchial aspirations, protected distal sampling, or mini-bronchoalveolar lavage as part of routine care. No additional samples will becollected for this study. Respiratory samples will be simultaneously tested by conventional microbiological techniques and multiplex respiratory PCR \[PCR-RM\] (BIOFIRE® FILMARRAY® Pneumonia Panel Plus). Classical microbiological culture (CMC) will be considered the gold standard for microbiological pneumonia diagnosis. The agreement between the results of the Pneumonia Plus® panel and the results of conventional microbial culture (CMC) will be assessed.

An empiric antibiotic therapy will be prescribed according to the local ecology and the protocols of each ICU unit. Two senior experts in each participating center will have to approve the antibiotic prescription. The antibiotic therapy could be modified after the reception of the Mutilpex PCR results by the two senior experts. After the reception of the results of the classic microbiological culture, the previous antibiotic changes will be judged as appropriate or inappropriate by a multidisciplinary team including intensivists, infectious disease specialists, and microbiologists. Appropriate changes include adequacy, de-escalation, and optimization of antibiotic therapy, and inappropriate changes include inadequacy, escalation, and de-optimization.

Eligibility Criteria:
Inclusion Criteria:

* critically ill adult patients
* clinical, biological, and radiological signs of severe pneumonia.
* community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
* invasive mechanical ventilation.

Exclusion Criteria:

- Non-invasive mechanical ventilation.
Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

The aim of DCR is to form a new, mucosa-lined pathway between the lacrimal sac and the nasal cavity where tears can bypass a lacrimal obstruction and drain directly in the nose. The original external approach was described in 19046. In 1920s, mucosal flap anastomosis was added to the procedure as a modification7, and since then, many new modifications have been made to improve the original procedure.

Aim of The Study

• To compare intraoperative details and postoperative endonasal endoscopic findings and their effects on success rate of external dacryocystorhinostomy with and without anastomosis of posterior mucosal flaps.

Patients and Methods

Study Design: This will be a prospective interventional comparative clinical study. It will include two groups according to the surgical procedure:- Group A: includes 30 eyes that will be treated with external DCR with anastomosis of posterior mucosal flaps .

Group B: includes 30 eyes that will be treated with external DCR with amputation of posterior mucosal flaps .

Study Population:

Study participants will be: 60 eyes undergo external DCR . All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Ophthalmology department, Minia university Hospital, Egypt.

Eligibility Criteria:
Inclusion criteria

* Patients with chronic dacryocystits,
* primary nasolacrimal duct obstruction
* Lacrimal mucocele
* Lacrimal fistula

Exclusion Criteria:

* Recurrent cases.
* Age under 5 years.
* Associated nasal pathology.
* Sever dry eye
* Patients unfit for general anaesthesia
Severity of the New UK SARS-Cov2 Variant in COVID-19 Infection

The COVID-19 epidemic has now raged for more than a year with more than 100 million identified cases and nearly 2.5 million deaths worldwide. Since November 2020, we have been witnessing the emergence of viral variants in different regions of the world. This expected genetic drift of the virus, but somewhat abrupt since November, raises questions concerning the characteristics of transmissibility, pathogenicity, sensitivity to possible treatments, and escape from natural or vaccine immunity. The objective of this study is to find out whether the new variants of SARS-CoV-2 are associated with particular clinical forms. The results of this research will provide elements to determine whether the new variants of SARS-CoV-2 are associated with more severe clinical forms.

SEVASAR is a paired cohort study with retrospective data collection:

* Presentation: patients hospitalized for COVID-19 with SARS-CoV-2 variant 20I / 501Y.V1
* Not exposed: patients hospitalized for COVID-19 with SARS-CoV-2 corresponding to wild variants type 20A. EU1 or 20A. EU2

The severity of illness will be compared between pairs. Disease severity will be assessed according to the following definition: defined by a composite criterion including, at 28 days after hospital admission: WHO scale \>5 /11 levels, (death OR need for invasive ventilation OR need for high flow ventilation (Optiflex or NIV or CPAP) or high concentration mask. This event will be taken into account regardless of its time of occurrence between the first day of the hospitalization studied and D29 after hospital admission.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Acute symptomatic PCR + COVID with screening
* Hospitalized for acute COVID between 01/01/2021 (or since the setting up of the screening in the center) and 02/28/2021

Exclusion Criteria:

* Opposition to participation
* Identification of variants other than 20I / 501Y.V1
* Patients infected with SARS-CoV-2 in a nosocomial context
Effect of Intensive Low Sodium Restriction on Glomerular Infiltration Rate in Chronic Kidney Disease

Introduction :

Due to Chronic kidney disease is a public health problem, which is important increased in both developed and developing countries . And sodium intake restriction was related to the reduction of blood pressure and urine protein which is one of the important risk factor in chronic kidney disease. One of the problem in sodium restriction failure in Thai population with CKD nowadays is lack of knowledge and problem unawareness.

The study hypothesis :

Intense knowledge about sodium reduction and immediate feedback of the sodium intake could be simultaneously modifying the behavior to reduce sodium intake , blood pressure and also GFR reduction rate

Objectives :

To compare the effect of dietary salt restriction on glomerular filtration rate (GFR) between CKD patients receiving strict controlled combined with immediate individual feedback (DISC Progrram) and those receiving standard education.

Study design :

Multicenter, open labeled, parallel, randomized controlled trial

Sample size : 600

Primary outcome : GFR reduction (CKD-EPI)

Secondary outcome :

* Achievement rate of Na intake \< 2 g/day (Urine Na \< 90 mEq/day)
* Blood pressure difference
* Proportions of patients with BP reached the target (130/80 mmHg)
* Number of anti-hypertensive drugs use to achieve BP target
* Urine albumin/creatinine ratio
* Major Adverse Cardiac Events (MACE)
* Cardio-ankle vascular index (CAVI)
* ankle-brachial index (ABI)

Documentary Proof of Ethical Clearance :

This project has been reviewed and approved by the Comittee on Human Rights Related to Research Involving Human Subjects , based on the declaration of Helsinki


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3-4 (eGFR 15-59 mL/min/1.73m²)
* Microalbuminuria
* Any blood pressure level

Exclusion Criteria:

* Salt - losing conditions
* Hyponatremia (Na \< 135 mg/dL) or Hypernatremia (Na \> 145 mg/dL)
* Bilateral renal artery stenosis
* Severe comorbid disease or life expectancy \<1 year (severe cardiovascular disease, chronic liver disease, severe infection , malignancy)
* Immunosuppressant used
Evaluation of the AMICUS RBCx System in Sickle Cell Patients

The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle cell disease.

The goal of Red Blood Cell Exchange is to remove a patient's red blood cells (RBCs) and replace the blood volume removed with either healthy donor RBCs and/or colloid/crystalloid solutions. Depending on the RF used, the procedure can be considered an RBC Exchange or RBC Depletion/Exchange procedure. The RBC Depletion/Exchange procedure is a modification of the RBC Exchange procedure. The AMICUS RBCx protocol provides the ability to use various RFs including healthy donor RBCs or a combination of fluids, such as saline followed by RBCs. In RBC Exchange and the exchange portion of the RBC Depletion/Exchange procedures, RBC units are used as the RF, while colloid and/or crystalloid solutions are used as the RF in the depletion portion of the RBC Depletion/Exchange procedures. A new operating protocol on the AMICUS Separator that enables the device to perform Red Blood Cell Exchange (RBCx) procedures in accordance with the replacement fluid(s) (RF) prescribed by a physician for patients with sickle cell disease

Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented diagnosis of a type of sickle cell disorder who require RBC Exchange or RBC Depletion/Exchange treatment.
* Medically stable subjects who have been previously treated for sickle cell disease with RBC Exchange or RBC Depletion/Exchange.
* Subjects, or subject's legal representative, who have provided signed informed consent, and assent when applicable, prior to participation.
* Adequate availability of sickle trait negative, leukoreduced, Blood type (ABO) blood group, Rhesus factor D (Rh (D)) compatible, unexpired replacement RBC products.
* Subjects with sufficient vascular access to accommodate the RBCx procedure as determined by the medical staff responsible for obtaining intravenous access.
* Subjects who are able and agree to report adverse events (AEs) during the required reporting period.

Exclusion Criteria:

* Procedures that occur during acute hospitalization.
* Procedures prescribed within one week of discharge of a hospitalization.
* Subjects with altered mental status that would prohibit the giving and understanding of informed consent, and assent when applicable, who do not have a legally authorized representative.
* Drug abuse, alcohol abuse, or other factors that in the opinion of the investigator could affect the ability of the subject to comply with the requirements of the protocol.
* Subjects who have experienced a serious adverse event associated with an RBCx procedure in the past.
* In the opinion of the investigator, subjects who have a life expectancy fewer than 30 days.
* Subjects who refuse blood products.
* Subjects who are pregnant.
* Subjects who fail to comply with site requirements for cessation of medication that interfere or increase procedure risk.
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain

The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the low back, when added to a multidisciplinary treatment program.


Eligibility Criteria:
Inclusion Criteria:

* Referred to the multidisciplinary clinic for treatment of pain in low back
* Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific low back pain
* Pain intensity ≥ 4 on numerical rating scale (0-10)

Exclusion Criteria:

* Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis)
* Psychiatric condition/disease that severely impairs group functioning
* Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires
* Awaiting surgery of back
* Alcohol or drug abuse
* Ongoing compensation case or applying for disability benefits due to pain in the back
* Engaged in high-intensity resistance training on a regular basis the last 6 months
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection

The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori infection in adult patients and its results will be compared to biopsy results.

Patients undergoing esophagogastroduodenoscopy (EGD) for initial diagnosis of H.pylori infection or post therapy confirmation of eradication will be eligible to participate in the trial. Two sets of biopsies will be taken: one set for histological analysis and one set for rapid urease test (RUT) analysis. The two results will be used as a gold standard composite score in determining the presence of H.pylori bacteria in the stomach. The Urea Breath Test (UBT) using the Exalenz Dual Mode BreathID Hp System will also be performed within a week of the biopsy. The outcome of the UBT will be compared to composite score of the biopsy and the accuracy of the UBT will be evaluated. The UBT will be performed using breath collection bags, where the subject will be asked to breathe into the bags before and after ingestion of the 13C-labelled urea.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Have the ability and willingness to sign the Informed Consent Form.
* Present with clinical indication of H. pylori and a candidate for upper endoscopy

For Initial Diagnosis arm:

• Symptomatic patients naïve to H.pylori treatment in the past 18 months

For Post-Therapy arm:

* Documented biopsy with positive outcome prior to eradication therapy (including method of determination)
* Documented eradication therapy within the past 6 months and completed at least 6 weeks prior to UBT

Exclusion Criteria:

* Participation in other interventional trials.

  * Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test.
  * PPI or H2 blockers within two (2) weeks prior to breath test.
  * Pregnant or breastfeeding women.
  * Allergy to test substrates.
  * Patient did not fast for the hour prior to the UBT
A Study of HIPEC Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells


Eligibility Criteria:
Inclusion Criteria:

* 1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); 2. Age:18 to 70 years old; 3. Man or female (except pregnant and lactating women); 4. Conﬁrmed to gastric adenocarcinoma; 5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive; 6. Blood cell count has to meet the following certeria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; 7. Liver/kidney function has to meet the following certeria: ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 9. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

- 1. Patients with other malignant tumors within 5 years; 2. Metastasis was found to be visible to the naked eye; 3. It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on); 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Patients with severe or uncontrollable mental illness; 6. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months; 7. Pregnant or lactating women; 8. It have serious harm to the patient's safety or affect the patients who have completed the research.

9. The researchers think inappropriate.
Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-14 when given with topotecan on days 1-5 of every 21 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-14 with topotecan on days 1-5 in 21 day cycles until disease progression is documented.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must understand and voluntarily sign an informed consent document.
2. Age \>or = to 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol requirements.
4. Histological or cytological documentation of advanced ovarian or primary peritoneal carcinoma.
5. Radiographic or clinical evidence of measurable metastatic advanced ovarian or primary peritoneal carcinoma. Subjects must have measurable disease at least 2 cm in diameter.
6. Subjects must have been treated and progressed following chemotherapy which includes platinum and paclitaxel.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).

Exclusion Criteria:

1. Any of the following laboratory abnormalities:

   1. Absolute neutrophil count (ANC) \<1,500 cells/mm3 (1.5 x 109/L)
   2. Platelet count \<100,000 cells/mm3 (100 x 109/L)
   3. Serum creatinine \>1.5 mg/dL (133 mmol/L)
   4. Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN)
   5. Serum total bilirubin \>2.0 mg/dL (34 mmol/L)
2. Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
3. Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the breast) unless the subject has been free of disease for \> 1 year.
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
5. More than 1 prior chemotherapy regimen. However, subjects with platinum sensitive disease (i.e., subjects who fail a platinum containing regimen at least six months after completing the regimen) who are retreated with a platinum containing regimen are eligible.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Prior \> or = to grade 3 (see Appendix III) rash or any desquamating (blistering) rash while taking thalidomide.
9. Prior . Or = to grade 3 (see Appendix III) allergic reaction/hypersensitivity to thalidomide.
10. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy.
11. Known active Hepatitis C.
The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI)

This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group.

This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. These scales will be applied to both groups before and after Intrauterine Insemination (IUI).

Virtual reality glasses will be applied to the intervention group during intrauterine insemination (IUI).

Keywords: Virtual reality, anxiety, patient satisfaction, Intrauterine Insemination (IUI)

Eligibility Criteria:
Inclusion Criteria:

* 18-45 age group
* Primary infertile,
* Able to speak and understand Turkish,
* Are cognitive, effective and have no problems preventing communication,
* Having no psychiatric problems,
* Not diagnosed with epilepsy (due to the possibility of virtual reality (VR) glasses triggering epileptic seizures),
* Women who volunteer to participate in the study will be recruited.

Exclusion Criteria:

* Having a psychiatric problem,
* Diagnosed with epilepsy
* Those who want to leave the study
Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy

The Effect of Virtual Reality Glasses on Applied During Thyroid Fine Needle Aspiration Biopsy on Anxiety Level, Pain Intensity and Patient Satisfaction

Beginning 1-2 minute before the start of the procedure, the patients will be watched (5-10 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Ability to communicate adequately
* Volunteering to participate in the research

Exclusion Criteria:

* Those with psychiatric problems
* Being unconscious