cyrilzakka/clinical-trials huggingface dataset:
Effect of IMMUNEPOTENT-CRP on Serum Pro-Inflammatory Cytokines in Mild to Moderate COVID-19

In this study, the effects of IMMUNEPOTENT-CRP (I-CRP), a dialyzable leukocyte extract (DLE) derived from bovine spleen cells, on the levels of key inflammatory cytokines in outpatients with COVID-19 were examined. I-CRP has been previously studied for its ability to regulate the immune system in other conditions, such as cancer and sepsis. Based on its potential to reduce harmful inflammation, the study aimed to determine if similar benefits could be observed in COVID-19 outpatients.

Outpatients with mild to moderate COVID-19 symptoms and a confirmed SARS-CoV-2 infection were enrolled. These patients were randomly assigned to receive either IMMUNEPOTENT-CRP (I-CRP) or a placebo over a 14-day period. The study was double-blind, meaning neither the patients nor the researchers knew who was receiving I-CRP or placebo, ensuring unbiased results. The main objective of the study was to measure changes in the levels of specific cytokines and chemokines in the blood-IL-1β, IL-6, IL-10, TNF-α, IFN-α, IFN-γ, and IL-8-which are key players in the inflammatory response linked to severe COVID-19 cases. High levels of these molecules are associated with worse outcomes and more severe symptoms. Additionally, other markers of inflammation and immune system activity, such as lactate dehydrogenase (LDH), high-sensitivity C-reactive protein (hs-CRP), ferritin, and D-dimer, were measured, as these are commonly used to assess the severity of inflammation and risk of complications in COVID-19 patients.

Throughout the study, outpatients were regularly monitored for symptoms, and their vital signs-such as oxygen levels and body temperature-were checked during home visits. Blood samples were collected at different intervals to measure cytokine levels and the other included inflammatory markers. Patients were also tested four times for the presence of the virus to determine their infection status during the follow-up period.

Eligibility Criteria:
Outpatients Inclusion Criteria:

* Laboratory-confirmed SARS-CoV-2 infection (by antigen or RT-qPCR test).
* With mild to moderate symptoms of COVID-19.
* Aged ≥ 18 years.
* Not participating in any other clinical study.
* Written informed consent duly signed.

Outpatients Exclusion Criteria:

* Undergoing any process of primary or secondary immunosuppression.
* Any autoimmune disease.
* Receiving chemotherapy.
* History of lymphoma or any malignancy.
* Pregnancy or breastfeeding women.
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants

The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria:

* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
* Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
* A positive urine drug test.
Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions

The goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. The main questions aim to answer are:

* Is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ?
* Is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? The middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.

Fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of Assiut university hospitals. Otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (Valsalva and Toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. Assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients

Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years old.
* Patients accept participation in the research.
* Patients with out history of middle ear diseases.

Exclusion Criteria:

* Patients under age of 18 years old.
* Patients have middle ear effusion.
* Patients refuse to participate in the research.
The Role of Morphological Phenotype in ARDS

Although most of the information focuses on understanding how the ventilator produces lung damage, the pulmonary factors that predispose to ventilator-induced lung injury (VILI) have been less studied. Acute respiratory distress syndrome (ARDS) can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. This morphological phenotypes may favor the development of VILI for same ventilatory strategy

The lung in acute respiratory distress syndrome ARDS) is a heterogeneous viscoelastic system, in which areas with different time constants coexist, causing tidal volume to be distributed unevenly within an anatomically and functionally reduced lung. The administration of a disproportionately high tidal volume for this lung predisposes to the over-distension of the better ventilated alveoli and to the injury by tidal opening and closing of the alveoli more unstable. In this sense, using low tidal volume and homogenizing the lung by means of the prone position have proven beneficial in ARDS.

Tidal volume, driving pressure, inspiratory flow and respiratory rate have been identified as responsible for mechanical ventilation-induced lung injury (VILI). These factors together represent the mechanical power, the insulting energy which is repeatedly applied to a vulnerable lung parenchyma.

Although most of the information focuses on understanding how the ventilator produces lung damage and/or amplifies the existing one, the pulmonary factors that predispose to VILI have been less studied. Acute respiratory distress syndrome can adopt different morphological phenotypes, with its own clinical and mechanical characteristics. Understanding how each subgroup of ARDS responds to the protective ventilatory strategy could help to personalize treatment.

Objectives: To compare the risk of VILI in two groups of ARDS with different morphological phenotypes (focal and non-focal), ventilated with the same protective strategy.

Design: Patients with ARDS were ventilated under the same conditions of both tidal volume (TV) and plateau pressure (PPlat). Positive End Expiratory Pressure (PEEP) was adjusted to reach 30 cmH2O of PPlat. A CT was performed in inspiration and expiration. Transpulmonary pressures (TP) were measured and lung volumes calculated (Volume Analysis Software,Toshiba, Japan). Stress was defined as TP at the end of inspiration (TPinsp) and strain: tidal volume/End Expiratory Lung Volume Patients were classified into focal and non-focal according to the distribution of aeration loss in CT. Mann - Whitney U test was used to compare variables and Pearson correlation coefficient to compare its correlation. Significant: p \<0.05

Eligibility Criteria:
Inclusion Criteria:

Acute respiratory distress syndrome (ARDS).

Exclusion Criteria:

Emphysema Asthma Pneumothorax Oxygen saturation ≤ 88% Severe shock Ventricular arrhythmia Myocardial ischemia.

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Reproducibility of the Functional Movement Screen Test

The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players.

The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports season in amateur rugby players.

Rugby is a very popular sport in France, since it has more than 300,000 dismissed. The 2023 World Cup will take place in France, and in view of the enthusiasm that is created around the "XV de France" team, there will be a great number of new players. Yet there are many injuries in this sport, despite the adaptations of the French Rugby Federation. The injuries of these amateur players will handicap their performance within their club (an injured player will be injured more easily in the future) and have a impact on their personal and professional life. With this in mind, it would be desirable to have a predictive tool for possible wounds. For this, Agullo et al. had in the previous study "Reproducibility of the Functional Movement Screen (FMS) test in the amateur Rugby player" (ID-RCB: 2018-A03490-55) selected this tool already evaluated in the context of prediction injuries in other sports (hockey or American football). The FMS offers an overall assessment of the subject, based on seven so-called movements fundamentals, combining mobility and stability, making it possible to assess the deficiencies of the individual; a prevention plan will then be adapted to the subject.

Eligibility Criteria:
Inclusion Criteria:

* Rugby players in the "Amateur" and "Senior" categories
* Must be able to play a match within a week of the FMS test evaluation.

Exclusion Criteria:

* players evolving or having evolved beyond the "Federal 3" division for men or "Federal 1" for women
* Pregnant and breastfeeding women
* People in an emergency situation
* People unable to give their consent (including people under guardianship)
* Patients already involved in another study.
ANTERO-5: Gastric Motility in Postoperative Ileus

A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus.

The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* At least 18 years old
* BMI between and including 18 and 30
* Understand and able to read Dutch
* Planned to undergo elective colorectal surgery

Exclusion Criteria:

* Known history of documented gastroparesis
* Known history of functional dyspepsia
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
* Known history of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* Suspected basal skull fracture or severe maxillofacial trauma
* Known history of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
Early Amiodarone in Shockable Cardiac Arrest

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

The primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

The null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (EMS) arrival on-scene or time of arrest if witnessed by EMS, in the modified protocol calling for earlier amiodarone administration compared to usual care.

Evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical EMS interventions, and clinical adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Emergency medical services (EMS)-treated non-traumatic out-of-hospital cardiac arrest
* Initial rhythm on EMS rhythm assessment of ventricular fibrillation or ventricular tachycardia
* Recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt

Exclusion Criteria:

* Known allergy to amiodarone
* EMS-assessed contraindication to amiodarone
* Pre-existing "do-not-attempt-resuscitation" orders
* Inter-facility transportations
* Initial care by a non-participating EMS agency able to perform advanced life support interventions
* Pediatric patient as determined by EMS
* Prisoners
* Pregnant patients
Periodic Versus Continuous IV Iron Supplementation in HD Patients

The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose \[continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)\] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Constant rHu-EPO and iron dose for at least 2 months before starting the study
* Hemoglobin ≥ 8,5g/dl and \<12,5 g/dl
* Ferritin \< 1000 mg/dl
* TSAT \< 50%
* CRP \< 5 mg/dl

Exclusion Criteria:

* Malignant tumor disease
* Oral iron supplementation
* Active bleeding issues
* Surgical intervention within the last 8 weeks before study inclusion
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb

This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \> 20 degrees of the thumb
* First web space contracture with a palpable cord due to Dupuytren's contracture

Exclusion Criteria:

* Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.
* Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
* Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
* Any subject with known allergy to Xiaflex (Clostridial collagenase).
* Pregnant or nursing female
* Any subject who cannot conform to the study visit schedule
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches

The purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

Almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. To date, none of these have been approved by the Food and Drug Administration (FDA) for use in adolescents. This is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. The total study duration will be up to one year. There is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. Almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. The primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. The study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. Safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ECGs) and the incidence of adverse events. A diary will be completed by the patient for each migraine headache for which they take almotriptan malate. Migraine pain information and almotriptan malate use will be recorded in the headache diary. An equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. Patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. The dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. Study medication will be taken for up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of migraine for at least one year
* Have an average of 1 - 14 migraines per month for the 6 months prior to study entry
* Able to swallow oral medication
* Able to complete a headache diary
* Only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study)

Exclusion Criteria:

* Have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects
* Have 15 or more days within a month in which you have a headache
* Usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache
* Experience more than 6 non-migraine headaches per month
HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS)

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with multiple sclerosis (MS).

The main questions it aims to answer are:

1. Can the current HOBSCOTCH program be adapted for people with MS?
2. Will people with MS experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?

Participants will be asked to:

* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-MS sessions with a one-on-one certified HOBSCOTCH-MS coach
* complete a brief clinical questionnaire about their diagnosis of MS
* complete four questionnaires before and after the HOBSCOTCH-MS sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their MS symptoms and use of the self-management strategies taught in the HOBSCOTCH-MS program
* complete a brief Satisfaction Survey after the entire HOBSCOTCH-MS program


Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 65 years
* Literate, English-speaking with grade 12 or equivalent in education
* Self-reported diagnosis of MS
* Self-reported cognitive/memory difficulties
* Telephone and internet access

Exclusion Criteria:

* Cognitive dysfunction that precludes participation in giving informed consent
* Significant visual impairment precluding reading or writing
* No reliable telephone or internet access
* Acute psychiatric illness
* History of progressive neurodegenerative disease (dementia)
Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye

The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral dry eyes
* Capable of providing written informed consent

Exclusion Criteria:

* Chronic or recurring epistaxis (nosebleeds)
* Uncontrolled systemic disease
* Blood coagulation disorder
* Females who are pregnant, nursing or planning a pregnancy
A Study on the Changes of the Biological Rhythm by Display Image Modulation

Effects of Smartphone Use at Night with Light Emitting Diode Display With and Without Blue Light in Healthy Adults: A Randomized, Double-blind, Cross-over, Placebo-controlled Comparison


Eligibility Criteria:
Inclusion Criteria:

(1) Healthy males 20-40 years of age who understood the study procedure and agreed to participate after being fully informed about the study were included.

Exclusion Criteria:

1. psychiatric diseases according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria;15
2. cognitive or neurological disorders;
3. alcohol or substance abuse;
4. unstable or serious medical illness;
5. current use of psychoactive mediations including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, or stimulant medications;
6. primary sleep disorder;
7. habitual sleep onset earlier than 21:00 or later than 24:00;
8. shift worker;
9. travel across more than two time zones within 90 days of the study; and
10. ophthalmologic disease during the study period.