cyrilzakka/clinical-trials huggingface dataset:
CT-FFR-guided Strategy for In-stent Restenosis

This study will be a prospective, randomized clinical trial to compare standard practice guided by usual care testing to CT-FFR-guided management in patients with in-stent restenosis.

This trial will randomize 294 patients with in-stent restenosis to receive either CT-FFR or routine clinical assessment. In all subjects, the investigators will review all diagnostic test results and determine a treatment strategy. The primary end point will be 12-month Major Adverse Coronary Event (MACE) rates, defined as all cause death, non-fatal myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR). Secondary end points will include total medical costs, and quality of life (QOL), medical radiation exposure, etc. We will test noninferiority of current FFR-guided strategy compared with standard care strategy.

Eligibility Criteria:
Inclusion Criteria:

* (1) \>18 years old;
* (2) ability to provide informed consent;
* (3) previous PCI who underwent CCTA and have at least 1 lesion with a percent diameter in-stent stenosis between 30% and 90% in a coronary artery with a ≥2.25 mm reference vessel diameter by visual assessment;
* (4) accepted further clinically indicated coronary testing, coronary arteriography, or FFR, or IVUS, or PCI, etc.

Exclusion Criteria:

* (1) Prior coronary artery bypass surgery (CABG), heart valve surgery, cardiac pacemaker, or implanted cardiac defibrillator;
* (2) Target vascular stents were evaluated for implantation within one month;
* (3) unstable clinical conditions including acute chest pain, cardiogenic shock, congestive heart failure (NYHA grade III or IV), unstable blood pressure (systolic blood pressure \< 90mmHg) or acute pulmonary edema;
* (4) Acute myocardial infarction occurred within 7 days before enrollment, and left ventricular ejection fraction ≤40%;
* (5) Other severe cases are not suitable for clinical trials including complex congenital heart disease, sick sinus syndrome, long QT syndrome, severe arrhythmia, tachycardia, severe asthma, severe or very severe chronic obstructive pulmonary disease (COPD) and severe chronic renal damage;
* (6) Contraindication to beta blockers, nitroglycerin, adenosine, or allergy to iodine contrast agents;
* (7) Pregnancy or pregnancy status unknown;
* (8) Life expectancy \<1 years;
* (9)Repeated enrollment;
* (10) Any other factors that other researchers consider not suitable for inclusion or completion of this study.
Study of Leukocyte Immunophenotype and the Lipid Transport System as Predictive Biomarkers of Severe Bacterial Infections

Current study evaluates the relationship between cell immunity and lipid transport systems in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis) in order to develop new methods for predicting the course and outcome of severe bacterial infections.

* To study the state of the immune system in patients with severe bacterial infections (on the model of pneumonia, infective endocarditis, sepsis): spontaneous and stimulated production of reactive oxygen species by blood neutrophils; spontaneous necroptosis, apoptosis and pyroptosis of neutrophils; the content of blood leukocyte subpopulations.
* Assess the clinical, biochemical status, state of the lipid transport system of patients with severe bacterial infections (in the model of pneumonia, infective endocarditis, sepsis), including determination of the cholesterol content in the cell membrane of T-cells and monocytes.
* To develop a method for predicting an unfavorable course and an algorithm for the treatment (immunocorrection) of severe bacterial infections (on the model of pneumonia, infectious endocarditis, sepsis) based on the determination of the clinical and immunological status, indicators of the lipid transport system and dysmetabolic disorders, and propose a correction method for the treatment of these diseases, supplementing existing clinical protocols (preparations of immunoglobulins, lipids for parenteral nutrition, possibly PCSK9 inhibitors).

Eligibility Criteria:
Inclusion Criteria:

* community-acquired pneumonia, severe course (according to IDSA / ATs criteria) and / or sepsis with different localization of the primary focus (SOFA\> 2);
* the patient's ability to comply with the instructions of the research doctor and follow the procedures required by the test protocol;
* informed consent.

Exclusion Criteria:

* acute and chronic heart failure;
* renal failure;
* acute and chronic liver failure;
* taking medications of the statin group during the last month before the study;
* diabetes in the stage of clinical and metabolic decompensation;
* acute and chronic leukemia, severe anemia;
* pregnancy or lactation;
* HIV infection;
* drug addiction;
* immunosuppressive therapy;
* malignant neoplasms over the past 5 years.
Study of CM326 Injection in Healthy Subjects

This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤ 65 years, healthy male.
* With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
* Subjects can communicate well with investigators and comply with protocol requirements.

Exclusion Criteria:

* Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
* Major surgery is planned during the study period.
* The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
* Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
* There are any reasons that the investigator believes will prevent the subject from participating in the study.
Cemented Versus Uncemented Total Knee Arthroplasty : a Prospective Randomized Study

The goal of this prospective randomized double-blind study is to compare clinical and radiological results of cemented and uncemented total knee arthroplasty (TKA).

Two hundred and fifty patients will be randomized in two groups : cemented TKA and uncemented TKA.

The primary outcome is the comparison of the International Knee Society (IKS) Score revised in 2011 at one year postoperative.

The second outcome is the comparison of standard one year-postoperative x-rays looking for signs of loosening.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis
* Need for a total knee arthroplasty

Exclusion Criteria:

* Age \< 50 or \> 80
* Need for a different procedure than a TKA
* Preoperative knee flexion \< 90°
* Need for a TKA associated with a combined femoral or tibial osteotomy
* Knee already operated except for arthroscopy
* Mediocre bone quality
Which Automated Methodology?

The aim of this study is to identify the modes of clinical research invitation that optimise digital responses from participants in primary care settings. This will be achieved by investigating and characterising response rates (recruitment) obtained from a hybrid of digital recruitment methods, in general practice settings.

Responses to this research will provide a single data item on general health to further characterise the sample and whether, since Covid-19, adults are more or less willing to participate in research.

When conducting research, which data collection method to use, can be a difficult decision for many researchers. Choosing an inappropriate method can result in untrustworthy findings and therefore wrong conclusions. The use of digital technologies to improve the quality and reduce the cost of health care services, is a vision set out by government in 2021. How digital technologies can be used, in carrying out health research, is an area that there is not a lot known about and needs further research. This study will therefore investigate how to invite people to take part in research and which digital methods people use, to take part.

It is commonly known that the recruitment of research participants from primary care settings is difficult. The Covid-19 pandemic however highlighted the importance of primary care, in the delivery of healthcare research, which is the setting where most patients visit. Being contacted about a research study of importance, is the first step in a patients journey towards taking part in a research study. Patients will though, often drop out before they actually consent to take part in a research study. A recent NIHR survey suggested a positive increase in the public's attitude to health research. This research study will also investigate whether, since Covid-19, people are actually more or less willing to take part in research and their reasons for this.

The digital methods used for collecting data in this study, will include: automated check-in screens; Short Messaging Service (SMS or text message) with online data collection; and postal invitations from the general practice, with online data collection accessed by a quick response (QR) code or website. All people of age 18 years and over, registered at a participating general practice, will be allowed to take part. Data collected will include demographics, a data item on general health and one on willingness to take part in research.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or over.
* Adults registered at participating general practices.

Exclusion Criteria:

* People under the age of 18 years.
* Adults who have asked for their medical records not to be used for research and have a relevant code indicating this included on their records.
Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use

Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normal electrocardiogram (ECG)
* Hemoglobin: male 13.4 - 17.0 g/dL, female 11,7- 15.3 g/dL
* Creatinine: male 60- 105 micromol/L female 45- 90 micromol/L
* ASAT: male 15- 45 U/L, female 15- 35 U/L
* ALAT: male 10- 70 U/L female 10- 45 U/L
* Gamma GT: male 10- 80 U/L female 10- 45 U/L
* HCG normal under 3 ye/L
* Fertile women must use safe contraception and have a negative serum HCG at inclusion

Exclusion Criteria:

* Taking any medications including herbal medicines the last week prior to first treatment visit
* History of drug abuse
* History of prior drug allergy
* Having any local nasal disease or nasal surgery or recent cold for the last week
* Pregnancy
* Fertile women not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper IUD, Sterilization) throughout the study period until their last visit.
* Lactating women
* Any reason why, in the opinion of the investigator, the patient should not participate
Effects of Different Stimuli in Patients With Disorders of Consciousness

In recent years, promoting wakening attempts in patients with disorders of consciousness are increasing, but there are a lack of objective indicators to evaluate the efficacy and further researches on the brain mechanism during the wakening processing. So, the study first assessed the cerebral response during emotional acoustic stimuli with quantitative EEG and ERP(Event-related potential), and next, the investigators explored the relationship between brain activation and patients' recovery.

Auditory stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (DOC)，especially the emotional sound; however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. In this study, investigators assessed the response of different brain regions to three acoustic stimuli using quantitative electroencephalography (QEEG) and ERP(Event-related potential),and further investigated the predictive value of QEEG in the prognosis of DOC.

Eligibility Criteria:
Brain-damaged patients :

Inclusion Criteria:

1. Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
2. Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
3. Lack of autonomic crisis since one week minimum
4. Medical condition considered stable
5. Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria:

1. hearing Problem
2. Uncontrolled Epilepsy
3. Autonomic crises
4. Medical unstable state
5. Pregnant or likely to be (interrogation data) or breastfeeding woman

Healthy participants :

Inclusion Criteria:

1. Subjects with normal hearing
2. Absence of neurological disorder
3. Subjects able to understand the experimental instructions

Exclusion Criteria:

1. Hearing problems and / or hearing loss higher than 30 decibels Hearing Level (dB HL) at a frequency band from 250 to 8000 Hz
2. Neurological disorders
3. Pregnant or likely to be (interrogation data) or breastfeeding woman
The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars

The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.

In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex.

Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids.

In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Patients medically within normal.
2. Cooperative patients and cooperative parents.
3. Children aged 4-7 years old.
4. Primary mandibular second molar.
5. Deep carious molars.
6. A history of spontaneous pain.
7. Molars with pulp exposure due to caries.
8. Absences of Internal resorption.
9. Absences of external pathological resorption.
10. where the bleeding could not be stopped following removal of the coronal pulp tissue

Exclusion Criteria:

1. Parents unable to give informed consent.
2. Necrotic pulp.
3. Unrestorable Teeth.
Studying T Cells in Blood and Bone Marrow Samples From Patients With Multiple Myeloma

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about T cells and plan better treatment for multiple myeloma.

PURPOSE: This research study is looking at T cells in blood and bone marrow samples from patients with multiple myeloma.

OBJECTIVES:

Primary

* To evaluate the feasibility of expanding myeloma-specific T cells using autologous ex vivo expanded B cells loaded with myeloma antigens as antigen-presenting cells (B-APCs) in peripheral blood and bone marrow samples from patients with multiple myeloma.

Secondary

* To examine the feasibility of selecting and expanding myeloma-specific T cells ex vivo using interferon γ release and CD3/CD28 stimulation.

OUTLINE: Peripheral blood and bone marrow samples are collected periodically for laboratory studies. Samples are analyzed to assess the feasibility of expanding autologous B cells ex vivo using CD40L and IL-4; the antigen-presenting phenotype of autologous B-cell antigen-presenting cells (B-APCs) using flow cytometry; and the antigen-presenting function of B-APCs using ELISPOT and chromium-release assay. Myeloma-specific interferon γ secreting T cells are isolated and selected using Miltenyi beads. The selected myeloma-specific T cells are expanded ex vivo using anti CD3/CD28 beads.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of multiple myeloma

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.

To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan
Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).

Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.

The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Women and men of legal age
* With or without TMDs symptoms and
* With or without self-reported jaw fatigue when eating

Exclusion Criteria:

* Subjects treated with any type of treatment requiring infiltration of the mandibular region
* Participants undergoing dental interventions in the last 3 months
* Individuals missing two or more teeth in the same quadrant.
* Inability to understand or speak catalan, spanish or english.
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.

Excessive bleeding during and after cardiac surgery is a serious complication. It exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-exploration.Antifibrinolytic drugs like aprotinin and tranexamic acid are proven to reduce bleeding tendency and transfusion requirement in cardiac surgery. The efficacy of these drugs is proven, especially for the unspecific proteinase inhibitor aprotinin, however, there are concerns about the safety and the high costs of this drug. There are only limited head-to-head comparisons of these two drugs.

In this double-blind, prospective, controlled study the efficacy of aprotinin and tranexamic acid is compared. Primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay. Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for combined and separate data analysis.The power of the study is calculated for this subgroup-analysis.

Secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* Patients undergoing primary CABG or Aortic valve replacement surgery

Exclusion Criteria:

* Previous sternotomy
* OPCAB surgery
* urgent/emergency operation
* Coumadin treatment
* previous aprotinin exposure
* preoperative renal impairment (Creatinine \> 2 mg/dL)
* patients refusing blood transfusions
* no informed consent
Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI

The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Eligibility Criteria:
Inclusion Criteria:

Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details

Exclusion Criteria:

Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details