cyrilzakka/clinical-trials huggingface dataset:
A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.


Eligibility Criteria:
Inclusion Criteria:

* Must provide written informed consent,
* Be between 12 years of age and older,
* Male or Female, females of non-child bearing potential or using reliable contraception
* Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
* Stable low dose of Inhaled Corticosteroids
* Non-smoker, 12 months smoking-free and \<=10-pack years history
* Otherwise healthy
* Other criteria apply

Exclusion Criteria:

* Pregnant
* Allergic to albuterol or severe milk protein allergy
* Must not be on another trial for 30days.
* Other criteria apply
Prosthetic Limbs After Leg Amputation: Alternative Method of Socket Design

People who have had a leg amputated often choose to use a prosthetic (artificial) leg. This study will evaluate a new method of making prosthetic legs for people who have had an amputation below the knee.

The traditional assumption when fabricating a transtibial amputee (TTA) socket is that the residual limb is not homogeneous in its ability to tolerate load. As a result, prosthetic sockets are currently fabricated by modifying a positive mold to account for this non-homogeneity; these are called rectified sockets. Unrectified sockets retain the shape of the residual limb, except for a distal end pad. Unrectified sockets use an alginate gel method of fabricating that is simpler and less time consuming than the method used to fabricate rectified sockets. This study will compare patient satisfaction and function with rectified and unrectified sockets.

Participants in this study will be randomized to either a recitified socket group or an unrectified socket group. Participants will wear the socket for a minimum of 4 weeks. Participants will then fill out a Prosthesis Evaluation Questionnaire (PEQ). The PEQ quantifies patient satisfaction by evaluating nine validated scales. Functional measures of energy expenditure, kinematics, and ground reaction forces during gait will also be collected. After 4 weeks, participants in the rectified socket group will switch to an unrectified socket and participants in the unrectified socket group will switch to a rectified socket. At the end of 4 weeks with the new socket, participants will once again fill out the PEQ and undergo functional assessment. At the end of study participation, each participant will freely choose the socket they wish to have in their final prosthesis.

Thus far, 10 study participants with unilateral transtibial amputations have been evaluated after randomly wearing both rectified and unrectified sockets for 4 weeks. Results indicated no differences between sockets for gait speed and timing, gait kinematics and kinetics, gait energy expenditure, and Rate of Perceived Exertion (RPE). There were also no differences in the Prosthetic Evaluation Questionnaire. Four participants selected the rectified socket and 6 selected the unrectified socket as their exit socket.

Eligibility Criteria:
Inclusion Criteria

* Unilateral transtibial amputation
* Mature residual limbs (i.e., no major change in stump volume due to atrophy or other destabilizing factors)
* Continuously worn a prosthesis for at least 1 year prior to study entry
* Scheduled for a new prosthesis
* Independent ambulation
* No acute health problems

Exclusion Criteria

* Constant recurring prosthetic problems (i.e., adherent scar tissue, neuromas, bony protuberances at distal end)
* Requires gel inserts, additional ply socks, or other atypical fitting components or methods
* Health status that prohibits patient from performing graded exercise test
Comparison of Intralase and Visumax Femtosecond Laser for Laser In Situ Keratomileusis

Emtosecond lasers are used in cutting the flap in LASIK procedures (laser corrective surgery for refractive error). Their use has decreased the incidence of serious complications when compared to the use of microkeratomes(mechanical blades). The commonest femtosecond laser currently used is 'Intralase'. A newer femtosecond laser 'Visumax' (Zeiss) is now available and differs from the Intralase in that it does not interfere with the curvature of the cornea when creating the flap. The Intralase applanates the cornea flat during flap creation which causes the intraocular pressure to be higher. Both Intralase and Visumax lasers are available to patients and surgeons to use at SNEC. The aim of the investigators study is to compare the two lasers in a randomization of left and right eyes in the same patient. The investigators want to measure any difference that the lower intraocular pressure may have during the creation of the flap. This will be measured with a questionaire on patient experience during the procedure and the outcomes of vision, refraction, contrast sensitivity, wave-front analysis, tear function,corneal sensation and flap thickness measured with anterior segment OCT during the post-operative follow up period. To date no-one has compared the use of these two femtosecond lasers. Both lasers are currently used clinically for flap creation at SNEC.


Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older.
* Cycloplegic spherical equivalent of \>-1.00D
* Refractive cylinder -4.00 D or less.
* Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
* Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
* Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
* No evidence of irregular astigmatism on corneal topography.
* Available to attend post-operative examinations for a 3 month period.

Exclusion Criteria:

* Progressive or unstable myopia and/or astigmatism.
* Clinical or corneal topographic evidence of keratoconus.
* Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
* Previous corneal surgery or trauma within the corneal flap zone.
* Patent corneal vascularization within 1mm of the corneal flap zone.
* Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
* Systemically immunocompromised.
* Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
* Pregnant or nursing.
Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction

Clonal hematopoiesis of indeterminate potential (CHIP) refers to a phenomenon in which blood cells with somatic mutation circulate in the peripheral blood due to abnormal proliferation and differentiation of mutant hematopoietic cells.

CHIP is considered one of the aging phenomena, and the mutant blood cells increased by CHIP cause chronic inflammation, thereby increasing the occurrence of atherosclerotic cardiovascular disease. Therefore, CHIP is known to be closely related to poor prognosis of ischemic heart failure. Meanwhile, chronic inflammation may be involved in the development of non-ischemic myocardial disease, which is one of the major causes of heart failure.

This study will identify CHIP and perform NLRP3 inflammasome assay in 100 non-ischemic heart failure patients and evaluate the relationship between CHIP and inflammation, imaging markers of heart failure, Left ventricle reverse remodeling after guideline-directed medical treatment, and prognosis of heart failure with reduced ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

1. As an adult over the age of 19
2. A history of left ventricular ejection fraction less than 40% on imaging tests within 3 years (HFrEF diagnosis),
3. Have a cardiac MRI taken within 3 months of being diagnosed with HFrEF,
4. A person who was diagnosed with non-ischemic heart failure by performing coronary artery imaging (angiography, CT) at the time of diagnosis of HFrEF

Exclusion Criteria:

1. Patients with confirmed ischemic cardiomyopathy (when stenosis of 75% or more of major coronary arteries is confirmed on coronary artery imaging or ischemic cardiomyopathy findings such as transmural late gadolinium enhancement on cardiac MRI)
2. History of solid cancer diagnosis and chemotherapy (drugs, radiation)
3. History of blood cancer
Correlation of Hyperghrelinemia With Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome

Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity and endocrine dysfunction that leads to cardiovascular disability and early death within the first 3 decades of life.To assess the significance of risk factors for future disabilities, carotid artery intima-media thickness (IMT) was measured and correlated with known atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index (BMI)-adjusted controls.

Main outcome measures: Correlation of IMT with age, standard deviation score of BMI (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), C-reactive protein, HOMA-IR and ghrelin.

Eligibility Criteria:
Inclusion Criteria:

* Prader Willi syndrome
* Children with obesity

Exclusion Criteria:

* Acute illness
* On regular medications except growth hormone
Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

Cognition was assessed using Minimental state examination (MMSE), Trail making tests A and B (TMT) tests, P300 and quantitative electroencephalography (QEEG) sleepiness was assessed using Epworth Sleepiness Scale (ESS), Karolinska sleepiness scale (KSS) and QEEG also polysomnography (PSG) was done for all participated subjects

\*The study is a case control study included 40 subjects, divided into 20 cases suffering from Excessive daytime sleepiness and 20 healthy control group.

all participants were subjected to:

1. Careful history taking and Complete neurological examination.
2. Initial assessment of cognition and sleepiness by two scales which were done once before sleep: Epworth Sleepiness Scale (ESS) and Minimental state examination (MMSE)
3. Scales and neurophysiological studies done before and after sleep:Karolinska sleepiness scale (KSS), Trail making tests A and B (TMT), P300, and QEEG
4. Polysomnography (PSG)

   * EEG was recorded for 20 minutes duration before and after sleep recording. In each EEG recording, alpha attenuation test (AAT) was done after 10 minutes of recording basal resting EEG, then the absolute power of 5 electrodes (CZ, T3, T4, T5, T6,) were studied in the following frequency bands: delta (0.5-3Hz), theta (4-7 Hz) and also the absolute power of (O1, O2) were studied in delta, theta and alpha (8-12 Hz) bands.

Eligibility Criteria:
Inclusion Criteria:

* The age ranges from 18 to 60 years. The age of all included subjects was 31-58 yrs old.
* The body mass index (BMI) range is 24.97-39.06 kg/m2 in patients and 23.40-43.0 kg/m2 in control group.
* Patients suffering from excessive daytime sleepiness symptoms according to the International Classification of Sleep Disorders definitions.

Exclusion Criteria:

* Patients suffering from EDS secondary to any sleep disorder other than sleep disordered breathing.
* Chronic debilitating disease as diabetes mellitus , hypertension or hyper- or hypo-thyroidism.
* Medications that could affect attention or vigilance as Benzodizipines, anti-psychotics or anti-epileptics.
A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps

Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old.
2. With bilateral chronic rhinosinusitis with nasal polyposis.
3. Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.
4. Nasal congestion score ≥2 at baseline.
5. Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and/or have contraindications or intolerance to SCS treatment, and/or received surgical for nasal polyps more than 6 months before screening.
6. Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.
7. Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.
8. Good adherence.

Exclusion Criteria:

1. Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives \[whichever is longer\] before baseline).
2. Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).
3. Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.
4. Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.
5. Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period.
6. Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.
7. Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.
8. Women who are pregnant, breastfeeding, or planning either during the study.
Retrospective Comparison of Pregnancy Outcome of Infertile Patients After Fresh and Warmed Single Blastocyst Transfer From 2014 to 2018.

The investigators retrospectively analysed the maternal and neonatal outcomes following a single fresh blastocyst transfer and a single warmed blastocyst transfer from procedures performed between 2014 and 2018 in a tertiary level university based fertility clinic.

Previous studies that analysed pregnancy outcomes in women who underwent frozen single blastocyst transfer have shown an increase rate of large for gestational age and very large for gestational age (Zhang et al., 2019),increased maternal risks of placenta accreta and pregnancy-induced hypertension (Ishihara et al.,2014),and lower risks of placenta previa, placental abruption, very pre-term birth, small for gestational age, and perinatal mortality (Sha, Yin, Cheng,\& Massey, 2018) than fresh blastocyst transfer.

The main outcome of this study is to analyse the rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed. Secondary outcomes include the incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.

The study database included all pregnancies occurred after both a single fresh and warmed blastocyst transfer between the five-year period from 2014 to 2018 at Humanitas Fertility Centre. The inclusion criteria were all patients, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst. With regards to exclusion criteria, the following were considered: ovodonation, suspended cycles and embryos which were subjected to pre-implantation genetic testing.The investigator performed a comparison of maternal and neonatal outcomes in these pregnancies which occurred in the same period of time and in the same age-group of women.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst (warmed or fresh).

Exclusion Criteria:

* Ovodonation, suspended cycles, and embryos subjected to pre-implantation genetic testing.
Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis

This study is being done to for two reasons:

* To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly.
* To learn about the quality of life changes (good and bad) you may experience with this medication.

The plan is to have 50 people take part in this study at Mayo Clinic Rochester. This research study is looking at people who have a new condition called erosive reflux esophagitis. Esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Acid reflux, over time, can wear away or erode the lining of your esophagus. This condition is called erosive esophagitis. The treating physician may start you on prescription strength acid reducing group of medications called Proton Pump Inhibitors (PPI). PPI medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Have either mild-to-moderate erosive reflux esophagitis
* Meet criteria for GERD symptoms.

Exclusion Criteria:

* Patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to PPI therapy.
* Patients expected to travel outside of the United States during the initial 8 weeks of PPI therapy.
* Pregnant women will be excluded as PPI's are not thought safe for the fetus (Pregnancy Category C). - Children younger than 18 years of age will be excluded.
* Other vulnerable populations, such as those with diminished mental acuity, will be excluded.
Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.

In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.

This prospective randomised case-control experimental study is being conducted in Riga East University Hospital (Latvia). Patients with total or subtotal open gastrectomy were divided into two groups - half patients in the Block group and half patients in the Control group. In the Block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. Catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision.

After surgery patients in the Block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. Additionaly ketorolac or trimeperidine infusion will be performed if VAS of pains more than 30mm. If pains continue, additional opioids will be performed.

Patients in the Control group received 0,9% NaCl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery Pain intensity will be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.

Eligibility Criteria:
Inclusion Criteria:

* Open Laparotomy and gastrectomy

Exclusion Criteria:

* acute surgery
The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery

This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* elective off-pump coronary artery bypass surgery

Exclusion Criteria:

* arrhythmia
* LV ejection fraction \< 50 %
* preoperative inotropic support
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).


Eligibility Criteria:
Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
* Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.