cyrilzakka/clinical-trials huggingface dataset:
Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care

This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.

COPD is a leading cause of morbidity and mortality worldwide. Comorbid diseases are an important factor in the prognosis and functional capabilities of COPD patients. There is a relationship between cardiac comorbidity and COPD exacerbation frequency within COPD patients. The main objective of this study is to compare the rate of moderate-severe COPD exacerbations in patients of all COPD severities with and without cardiovascular diseases. Secondary objectives will characterize the prevalence, severity and incidence over time of comorbidities and explore the relationships between comorbidities and rate of COPD exacerbations, force expiratory volume in 1 second (FEV1) decline and quality of life. This will be a prospective, observational, non-drug interventional, non-randomized study that will be carried out in up to 8 European countries. All patients will be enrolled by GP outpatient clinics and data will be collected over 4 visits (screening \[-3 months\], baseline, 12 months post baseline 24 months post baseline) and, additionally by 6 telephone calls (at 3, 6, 9, 15, 18 and 21 months post baseline). The study population will consist of 3330 evaluable patients with diagnosed COPD of any severity grade with and without comorbidities. Subjective and objective data on pre-defined comorbidities will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 40 years
* An established clinical history of COPD for a minimum of 12 months, of any severity.
* FEV1/FVC post-bronchodilator ratio \< 0.70 (within the last 12 months, or confirmed at the screening visit \[or 4 weeks after the screening visit if patient's COPD is not stable\]).
* Current or ex-smokers with a smoking history of at least 10 pack-years
* A signed and dated written informed consent is obtained prior to participation

Exclusion Criteria:

* In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included)
* A diagnosis of fibrosis or asbestosis
* Diagnosis of cancer - current or within the last 5 years (patients in remission for ≥ 5 years may be included). Patients diagnosed with cancer during the study will be withdrawn
* Diagnosis of clinically significant bronchiectasis
* Subjects who are concurrently participating in any clinical study or who have received any investigational drugs within 4 weeks of baseline, or who will start any during the study period.
* Unable to or unwilling to conform with the study requirements including completion of the health status questionnaires
* Females who are pregnant or lactating.
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.


Eligibility Criteria:
Inclusion Criteria:

- Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery

Exclusion Criteria:

* All types of pulmonary hypertension other than Dana Point Classification Group 4
* Operable patients listed for PEA (Pulmonary Endarterectomy)
Identifcation of Biomarkers for Active Pulmonary Tuberculosis

This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* patients with active tuberculosis and latent tuberculosis infection

Exclusion Criteria:

* have other serious health problems
Effect of Two Different Methods on Pain and Anxiety

The aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.The hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety.

This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in the general surgery clinic of Necmettin Erbakan University Meram Medical Faculty Hospital. Patients will be randomly assigned to three groups: ball squeezing (37), virtual reality glasses (37) and control group (37). For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. For Ball Squeezing Group: Patients will be given a ball and instructed to tighten and loosen with their free hand during intravenöz catheter placement. The intravenöz catheter insertion attempt will be made while the patient continues to squeeze the ball. For Control Group: No application will be made during intravenous catheter placement in the control group.The primary outcome of this study was to determine the patients' pain scores during the peripheral venous cannula insertion process.The secondary outcomes of the study were to determine the patients' anxiety levels.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the General Surgery clinic.
* No verbal, perceptual and visual communication problems,
* Being between 18 - 65 years old,
* Being literate,
* Volunteer to participate in the research,
* Not using drugs that will create a chronic analgesic effect,
* Absence of chronic or acute pain,
* No intervention in the last month in the vein where an IV catheter was placed.
* The absence of scar tissue and infection in the areas to be used for IV catheter placement,
* It was determined as not having a disease (such as neuropathy) that would cause problems in feeling pain.

Exclusion Criteria:

* The individual's desire to leave the study,
* Inability to perform the ball squeezing motion,
* Feeling unwell during IV catheter placement (such as dizziness, palpitations),
* During use of VR, the patient experiences symptoms such as nausea and dizziness,
* Using sedatives or alcohol,

Termination criteria

• Failure of PIV catheter placement,
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.

This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>18 years
* Diagnosis of Type 1 or Type 2 diabetes
* BCVA score using the ETDRS method of \>24 and \<78 in the study eye at the screening visit
* 3 or more intravitreal injections of AntiVEGF over the 5 months prior to screening
* Presence of diabetic macular edema defined as SD-OCT CST \>320 microns on spectral domain machine

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study:

  * Anti-VEGF treatment in the study eye within 3 weeks prior to screening
  * Intravitreal Ozurdex treatment in the study eye within 12 weeks prior to screening
  * Intravitreal steroid treatment in the study eye within 8 weeks prior to screening
  * PRP or focal laser in the study eye within 4 months prior to screening
  * Active iris neovascularization in the study eye
  * Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result.
  * History of cataract surgery in the study eye within 3 months prior to screening visit
  * Uncontrolled systemic disease
  * Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the screening visit
  * Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception.
  * Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study.
  * Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine.
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19

The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs).

The secondary objectives of the study are:

* To assess the concentration-time profile of REGN15160 in serum
* To assess the immunogenicity of REGN15160


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a SARS-CoV-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (RT-PCR) test or other molecular diagnostic assay and sample collection following assay standards
2. Has received complete primary series of standard-of-care COVID-19 vaccination per local guidance, completed at least 2 weeks prior to screening
3. Has a body mass index (BMI) between 18 and 31 kg/m2 (inclusive) at the screening visit
4. Is judged by the investigator to be in good health based on medical history, as defined in the protocol
5. Is in good health based on laboratory safety testing obtained at the screening visit

Key Exclusion Criteria:

1. History of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
2. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
3. Has history of alcohol or drug abuse as determined by the investigator
4. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
5. Use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed
6. Participated in any clinical research study evaluating another investigational drug including biologics or therapy, including specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit
7. Is a pregnant or breastfeeding woman
8. Is a woman of childbearing potential (WOCBP)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty

Determine if genicular nerve radiofrequency ablation (RFA) is a clinically effective intervention for patients with chronic knee pain post-total knee arthroplasty (TKA) as defined by pain.

More than 600,000 total knee arthroplasty (TKA) surgeries are performed each year in the United States, and approximately 20% of patients will experience some element of chronic knee pain or dissatisfaction related to pain following this procedure. The options for management are limited, and physicians often resort to chronic opioid management. This creates a less than ideal situation for our elderly population who are more sensitive to the deleterious effects of opioids and who would greatly benefit from pain-free, independent mobility. The investigators propose a single-arm pilot study looking at performing fluoroscopically guided genicular nerve radiofrequency ablation (RFA) for patients with chronic (\>6 months) knee pain following a TKA.

A new paradigm for treating post-TKA pain may be the use of RFA of the articular sensory nerve supply of the knee capsule, to desensitize the knee by blocking sensory afferents of the anterior capsule and thereby decreasing pain. While this modality has demonstrated efficacy for chronic knee pain due to osteoarthritis (OA) in the native knee, only one underpowered study has investigated this technique in chronic pain post-TKA. Further, this study targeted only three genicular nerves, while newer cadaveric studies have suggested multiple additional sensory nerves which if ablated may result in increased pain relief. A placebo-controlled explanatory trial of genicular nerve RFA for chronic pain post-TKA of appropriate size and statistical methodology has not been conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 90 years
* At least one year post TKA
* Have no indications for revision TKA
* ≥4/10 knee pain for \>6 months following TKA
* ≥80% relief with diagnostic genicular nerve blocks
* Willingness to undergo fluoroscopy-guided genicular nerve RFA treatment.

Exclusion Criteria:

* Conditions that preclude RFA (e.g. pregnancy, pacemaker/ICD, severe cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic.
* Inability to write, speak or read in English
* Patient refusal
* Significant psychiatric comorbidity
Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia

Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested.

At the moment the majority of ICU admissions in Slovenia are due to severe Covid19 pneumonia. Despite intensive supportive treatment the mortality of these patients is high, around 30%. The main reason for ICU admission is respiratory failure, these patients usually do not have multiorgan failure on admisssion. In the early phase of disease the inflamatory, endothelial and microcirculatory response is different than that in "classic" septic shock. One of the most common complications later in the course of severe Covid19 pneumonia is sepsis, which is defined as a life threatening syndrome with the failure of one or more organs due to disregulated inflamatory host response. This definition can be connected to the majority of patients who die.

It is not well known which factors predict sepsis development in patients with severe Covid19 pneumnia. In a laboratory mode the coagulation abnormality have been shown to be one of them. One of the earliest features of sepsis are microcirculation dysfunction and oxygene consumption abnormalities. Many studies have shown that with near infrared spectroscopy, we can reliably assess these abnormalities. With this method the tissue oxygene saturation can be measured. With vasoocclusive test the rate of tissue deoxygenation during stagnant ischemia and the rate of reoxygenation after flow release can be determined. It has been shown that the inclination of both curves decreases in sepsis. The measurements have also prognostic value.

With the clinical study we want to detect the microcirculatory abnormalities, typical for sepsis, early in the course, before the clinical and laboratory signs of multiorgan failure develop.

Aim of the study is to test hypotheis that NIRS measurements can predict sepsis development early and that machanically ventilated (due to Covid 19 pneumonia) patients with microcirculatory abnormalities have worse prognosis than those with preserved microcirculatory function.

Eligibility Criteria:
Inclusion Criteria:

* Severe respiratory failure due to Covid19 pneumonia
* Sedated, mechanically ventilated patient

Exclusion Criteria:

* Sepsis with multiorgan failure present on admisssion
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine

Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months to \< 2 years of age. The last study visit is on Day 422 when subjects will be contacted via telephone / home visit system to assess for adverse events and concomitant medications.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
2. The subjects' parents/guardians are able to understand and sign the ICF.

Exclusion Criteria:

1. Age \< 2 months or ≥ 6 years.
2. For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
3. Has poor venous access (for subjects in sub-study only).
4. Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
5. Has had previous known exposure to EV71 or has received EV71 vaccine.
6. Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
7. Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
8. Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
9. Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
10. Has confirmed or suspected autoimmune disorder, or immunodeficiency.
11. Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
12. Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
13. Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for \> 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (Inhaled and topical steroids are allowed).
14. Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.

All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery

Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis.

Osteotomy can be performed in minus or in plus, at the latter case with or without interposition of tissue (autologous bone, heterologous bone or bone substitute).

Even though excessive bleeding is not a frequent complication, the blood loss and formation of subcutaneous haematoma can determinate more post-interventional pain, wound suffering and the risk of infections.

Tranexamic acid is an antifibrinolytic agent and its use in proximal tibia osteotomies has been retrospectively evaluated in a number of papers, all of which agree on its safety and efficacy in terms of reducing peri-operative bleeding. However, to date there have been no randomised clinical trials demonstrating its superiority in terms of reducing bleeding, subcutaneous haematoma and wound complications in proximal tibia osteotomies.

This is a randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding , pain and wound complications reduction in tibial osteotomies

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged between 18 and 70 years;
2. Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation \> 5°;
3. Surgical indication for corrective osteotomy;
4. Isolated osteotomy surgical procedure.

Exclusion Criteria:

1. Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;
2. Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
3. BMI \> 40;
4. Incapacitated patients;
5. Patients abusing alcoholic beverages, drugs or medication.
6. Patients who are pregnant or breastfeeding.