cyrilzakka/clinical-trials huggingface dataset:
MRI and Lung Function Measures of Benralizumab Response in Asthma

New treatments have been developed for asthma that are good at preventing asthma attacks and improving day-to-day symptoms. Alongside the development of these new drugs, there are new ways of measuring how the lung is affected by asthma. In particular, investigators have developed ways of seeing how air moves in the lungs of people with asthma, using MRI scanning. This study aims to see how quickly these new drugs result in changes in the way the lung is working, as seen in the MRI scans and other breathing tests. This will help clinicians in the future to decide who is likely to respond to these new medicines, and once patients have started taking the drugs, will help clinicians to decide whether long term treatment is likely to benefit the people receiving them.

In this study, the investigators plan to do extra breathing tests and MRI scans on people who are receiving the drug as part of their usual clinical care. The study will not change an individual's treatment, but will give the investigators more information about the patients' illnesses and the way the patients' bodies respond to treatment.


Eligibility Criteria:
Inclusion Criteria:

* People with eosinophilic asthma meeting the National Institute for Health and Clinical Excellence (NICE) criteria for benralizumab therapy based on eosinophil count and exacerbation rates will be offered the chance to participate in this study.

Exclusion Criteria:

* Any medical illness that in the opinion of the investigator is likely to significantly impact on the response to benralizumab or the outcome of the MRI and lung function testing.
* Non-concordance with routine asthma therapies (this would be assessed as a mandatory part of NICE-based criteria).
* Any additional significant lung illness that would impact on likelihood of response to benralizumab. Of note, trivial stable bronchiectasis that in the opinion of the patient's clinician is not clinically significant nor likely to result in either recurrent exacerbations or impairment of interpretation of investigation results will not be exclusion criteria. Part of the initial inclusion regarding eligibility by NICE criteria include an assessment of a likely eosinophilic asthmatic phenotype with probability of treatment response, and potential subjects with complex lung disease would be unlikely to be eligible.
* Current cigarette smoking, or cigarette smoking within the past 6 months
* Significant lifetime smoking history of ≥20 pack years
* Previous use of another biologic therapy targeting eosinophils within 6 months of enrollment
* Pregnancy, planning pregnancy, or breast feeding. Women of childbearing potential must use effective contraception (concordant use of hormonal contraceptive, intrauterine device, total abstinence), and urine pregnancy tests will be performed before scans.
* Abnormal renal function (eGFR \<30), to avoid risks from Gadolinium chelate MRI contrast agents.
SEEQ™ Performance Study

The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).


Eligibility Criteria:
Inclusion Criteria:

* Patient is indicated for a SEEQ™ MCT/ECM System for approved indications
* Patient is 18 years of age or older
* Patient is willing and able to provide consent and authorize the use and disclosure of health information
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient has known allergy and/or hypersensitivity to adhesives or hydrogel.
* Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring.
* Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™
* Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19

This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine delivered via pMDI compared with a matching placebo in conjunction with standard of care treatments on recovery in patients hospitalized due to COVID-19 infection.

Expploratory endpoint, pilot study, not statistically powered

go to protocol

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent indicating that they understand the purpose of the study and study procedures and agree to comply with the requirements and restrictions listed in the informed consent form and in this protocol.
* Patient must be at least 18 years of age and less than or equal to 80 years of age at the time of informed consent.
* Males are eligible to participate or females of non-childbearing potential or WOCBP who have a negative pregnancy test at screening are eligible to participate. WOCBP and female partners of male participants agree to either abstinence or use at least one primary form of highly effective contraception not including hormonal contraception from the time of screening through Day 60 following the first dose of study medication.
* Clinical status consistent with 3, 4 or 5 on the Ordinal scale: Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring any supplemental oxygen; Hospitalized, requiring non-invasive ventilation or use of high flow oxygen devices.
* Admission to hospital AND have a confirmed diagnosis of severe acute respiratory syndrome coronavirus (SARS-COV-2) infection confirmed by polymerase chain reaction (PCR) test AND displays at least one of the following: Respiratory rate \> 24 breaths per minute; new cough; new atypical chest pain; new dyspnea; oxygen saturation \< 97% at rest; chest x-ray with new changes consistent with COVID-related airspace disease.
* Capable of complying with all study restrictions and procedures including ability to use the pMDI correctly.

Exclusion Criteria:

* Participation in any other clinical trial of an experimental treatment for COVID-19, unless related to an expanded access program as part of Standard of Care at screening or during study.
* Evidence of multiorgan failure.
* Requiring mechanical ventilation at screening.
* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN) at screening.
* Creatinine clearance \< 30 mL/min at screening.
* Pregnancy or lactation at screening.
* Allergy or other contraindication or one of ensifentrine.
* In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
* Use of prohibited medications (theophylline, PDE4 inhibitors \[e.g. roflumilast, apremilast, crisaborole\] within 48 hours of screening or during study)
* Any other reason that the Investigator considers makes the patient unsuitable to participate.
Use of Artificial Intelligence in Oral Radiology: A Multicenter Cross-Sectional Study in Egypt

The survey aims to assess knowledge and perceptions of AI applications in dental imaging among Egyptian dentists. It also aims to identify the needs and challenges of implementing this transformative technology into education, training, and clinical practice.

Artificial Intelligence (AI) is advancing rapidly in the field of dentistry, particularly in diagnostic imaging. These AI-based tools are aiding dentists by making it easier to detect important structures and identify health issues with greater accuracy. Dentists around the world, including those in Egypt, are gradually integrating AI into oral radiology. However, the successful use of AI depends heavily on the dentists being aware and prepared to use it effectively. The Egyptian government is very keen on incorporating AI into healthcare and has developed programs like the National Artificial Intelligence Strategy to promote its use. Despite these efforts, research on Egyptian dentists' comprehension and views about AI in oral radiology is still limited. The study seeks to evaluate Egyptian dentists' knowledge about AI and to uncover the primary obstacles that prevent them from utilizing AI effectively in clinical settings.

A cross-sectional survey was conducted online among Egyptian dentists. The questionnaire aimed to assess their knowledge, attitudes, and perceived challenges related to AI in oral radiology. Dentists were recruited through academic institutions, professional organizations, and social media platforms. To identify factors influencing respondents' knowledge about AI, a logistic regression analysis was applied.

Eligibility Criteria:
Inclusion Criteria:

* graduated dentists with a bachelor's or higher degree from Egyptian universities who practiced in Egypt.

Exclusion Criteria:

* Undergraduate students and dentists who obtained their undergraduate qualification abroad or practiced outside Egypt were excluded.
Effect of Pulsed Magnetic Field Versus Low Level Laser Therapy on Functional Performance in Children With Juvenile Idiopathic Arthritis

the purpose of this study is to compare between the effect of pulsed magnetic field versus low level laser therapy on functional performance in children with juvenile idiopathic arthritis

This study directed to investigate effect of pulsed magnetic field versus low level laser therapy on functional performance in children with juvenile idiopathic arthritis children with juvenile idiopathic arthritis suffer from some problems such as pain, swelling and limited motion in knee joints here in this study i used these devices to help in solving these problems pain was measured by visual analogue scale swelling was measured by tape measurement and Range of motion was measured by digital geniometre

Eligibility Criteria:
Inclusion Criteria:

* 1 Confirmed diagnosis of Juvenile Idiopathic Arthritis (JIA).
* 2 Polyarticular onset of JIA with bilateral involvement of the knee joint.
* 3 Age between 8 and 16 years
* 4 Stable conditions (i.e., receive stable doses of medications in the past three months).
* 5 Not participating in a regular exercise program in the past six months.

Exclusion Criteria:

* 1 Fixed deformities
* 2 History of joint surgery
* 3 Ankylosing or fractures
* 4 Bone destruction ( erosive changes of the knee joints ).
A Study of an Investigational Drug, ALN-AAT, in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.


Eligibility Criteria:
Inclusion Criteria:

* Adequate complete blood counts, liver and renal function.
* 12-lead electrocardiogram (ECG) within normal limits
* Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization
* Male subjects agree to use appropriate contraception
* Willing to provide written informed consent and willing to comply with study requirements
* Nonsmokers for at least 5 years before screening

Exclusion Criteria:

* Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* Active serious mental illness or psychiatric disorder requiring current pharmacological intervention
* History or evidence of alcohol or drug abuse within 12 months before screening.
* History of intolerance to SC injection
Detection of Gastrointestinal Bleeding in Intensive Care Patients Via Biosensor Watch

The purpose of this study to improve methods of monitoring and diagnosing gastrointestinal bleeding via the E4 wristband, a biosensor watch.

The annual occurrence of gastrointestinal (GI) bleeding is approximately 150 per 100,000 in the US and accounts for 300,000 hospitalizations per year with a death rate of 5%. Qualitative assessments of blood tests monitoring patients with or are thought to have GI bleeding can lack accuracy and objectivity, delaying conformation of the bleed through endoscopy. Early endoscopies have been linked to more favorable outcomes for patients with heavier GI bleeding and earlier discharge times for patients with less severe GI bleeding. Additionally, laboratory values are not documented at regular intervals, which makes identifying when GI bleeding exactly occurred difficult. In this study, the investigators aim to improve methods of monitoring and diagnosing GI bleeding via the E4 wristband, a biosensor watch. Using data from the E4 wristband, the investigators will train a model to recognize GI bleeding through analyzing the heart rate and skin conductance of both patients with GI bleeding and who may have GI bleeding while they are not bleeding and while they are bleeding. Monitoring both types of patients while they are and are not bleeding will help the model discern which vital signs are critical. Additionally, the investigators will be using blood tests and other traditional methods of diagnosis to create a standard for vitals that characterize GI bleeding. If the E4 wristband is successfully able to accurately identify when a patient is experiencing GI bleeding, then speed of GI bleeding detection and the ability to monitor GI bleeding will dramatically increase, leading to quicker discharge times, reduced risk of rebleeding, and a lower death rate for afflicted patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of gastrointestinal bleeding and/or showing the symptoms of gastrointestinal bleeding.

Exclusion Criteria:

* Patients who are not showing the symptoms of gastrointestinal bleeding and/or do not have a history of gastrointestinal bleeding.
Effects of Dairy Foods on Adolescent Pregnant Mothers and Their Newborns

The purpose of the study is to evaluate the effects of different dietary calcium have on the pregnant teen mother and her newborn. We hypothesize that the higher calcium intake during pregnancy will result in higher bone mass in the newborn.

Osteoporosis in the adult remains a significant public health problem. One of the major causes of osteoporosis is the inadequate calcium intake during the pediatric age range of birth to 20 years of age. We believe that this low calcium may start at birth since the fetus is actively accumulating calcium during the last trimester of pregnancy. Adolescents generally have poor calcium intake. Our study is to compare the newborn bone mass from adolescent mothers who are taking the recommended calcium intake from dairy foods or non-dairy foods such as orange juice during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant mothers aged 15 to 18 years, term gestation

Exclusion Criteria:

* Chronic disease such as hypertension, diabetes, medications that will affect calcium metabolism
Liposuction as Treatment for Excessive Axillary Sweat

The purpose of this study is to determine if suction-curettage of the axilla is favorable in regard to effect, recovery and cosmetic appearance compared to standard surgical excision of the skin of the axilla in case of excessive sweating.

The surgical standard treatment for isolated excessive axillary sweating is excision of the hair-bearing area of the axilla. This technique is associated with a risk of impaired wound healing, infections, wide scars and a risk of impairment in the movement of the arm (seldom).

A new technique suction-curettage, much alike the liposuction technique, in which the dermis is curettage from a sub-dermal approach with a cutting and sucking devise, may be promising in regard to recovery and cosmetic appearance postoperatively, but the effect of the sweat production is not well known. This study compares liposuction vs. standard excision in individuals with isolated excessive isolated axillary sweating randomized to treatment with one of each technique in both axillas.

Eligibility Criteria:
Inclusion Criteria:

* Adult individuals with primary axillary hyperhidrosis

Exclusion Criteria:

* Secondary axillary hyperhidrosis
* Hidrosadenitis axillaris/inguinalis
* Prior surgery
* Iontophoresis or botox treatment 12 months prior
* Known hypersensitivity to local analgetics (lidocaine)
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients

This study will assess the effect of a 24-week withdrawal followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Rebound phenomenon will be assessed for subjects who have permanently withdrawn from further belimumab treatment.

This study will assess the effect of a 24-week withdrawal of belimumab followed by a 28-week reintroduction of belimumab 10 mg/kg plus standard of care medications on immunogenicity, markers of biological activity, efficacy, and safety in subjects with stable low systemic lupus erythematosus (SLE) disease activity. Additionally, this study will assess rebound phenomenon in subjects with any disease level of SLE who have permanently withdrawn from further belimumab treatment

Eligibility Criteria:
Inclusion Criteria:

* Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study.
* Be 18 years of age at the Day 0 visit.
* Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol.
* Able to provide written informed consent to participate.
* Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a SELENA SLEDAI score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0.
* Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies.

Exclusion Criteria:

* Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk.
* Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study.
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.

Eligibility Criteria:
Inclusion Criteria:

* BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
* ECOG performance status of 0 to 2.
* The patient was born in Japan and both parents and grandparents are Japanese.
* Adequate hematologic, hepatic and renal function.
* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.

Exclusion Criteria:

* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
* QTc \>470 ms.
Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients.

The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.


Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-lactating females aged ≥ 40.
2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction. Post-salbutamol FEV1/FVC \< 70% at Screening Visit (Visit 1) (i.e., 100xpost-salbutamol FEV1/FVC \<70%).
3. Current, or ex-cigarette smoker with a smoking history of at least 10 pack-years.
4. Patient whose FEV1 at the Screening Visit measured between 10-15 minutes post inhalation of salbutamol is 30% \< FEV1 \<80% of the predicted normal value (i.e., 100 x Post-salbutamol FEV1/ Predicted FEV1 must be \< 80% and ≥ 30%).
5. Female patients at least 1 year post-menopausal, surgically sterile (defined as having a hysterectomy or tubal ligation), or practicing a medically approved and highly effective method of contraception.
6. Patients who understand the study procedures and are willing to participate in the study as indicated by signing the informed consent.

Exclusion Criteria:

1. History or current diagnosis of asthma.
2. Clinically significant respiratory conditions other than COPD at the time of Inform Consent signature
3. Hospitalisation due to COPD exacerbation within the previous 3 months.
4. Signs of a COPD exacerbation or respiratory infection (including the upper respiratory tract) within the previous 6 weeks.
5. Clinically significant cardiovascular conditions
6. Presence of symptomatic prostatic hypertrophy and/or bladder neck obstruction.
7. Presence of narrow-angle glaucoma.
8. QTcB) above 470 milliseconds in the ECG performed at Screening Visit,
9. Patient who does not maintain regular day/night, waking/sleeping cycles