rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
BenRalizumab Effect on Airway Remodeling in Severe asTHma
Status: Recruiting

Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.

Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.

Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.

Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Written informed consent must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation informed consent form): Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. Confirmed severe asthma diagnosis and treatment requirements according to American Thoracic Society(ATS)/European Respiratory Society (ERS) guidelines and Global Initiative for Asthma (GINA) 2023. Blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months. Patients with history ≥ 1 exacerbation the previous year under the treatment of high dose of inhaled corticosteroid(ICS)+LABA±LAMA or receiving oral/systemic corticosteroids at least 3 days. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days. Meet requirements for biologic therapy with Benralizumab.  Exclusion Criteria:  Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit. Prior use of other biologics that has potential to interfere/ affect disease progression. Pregnant or nursing women, or women of child-bearing potential. History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician. Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Hydrolysed Rice Formula Study
Status: Recruiting

This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female Aged 0-13 months Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA Will receive at least 30% of energy requirements from the study formula Written informed consent from parent/carer  Exclusion Criteria:  Severe CMA (including anaphylaxis) and/or requiring an AAF Faltering growth (based on NICE guidelines36 - Appendix 1) Previous allergy to any study product ingredients (including whey hydrolysate and/or rice) Primary lactose intolerance Food Protein-Induced Enterocolitis Syndrome (FPIES) Exclusively breast fed Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes Severe hepatic or renal insufficiency Premature infants (born <37 weeks) with a corrected age of <4 weeks Requirement for any parenteral nutrition Participation in other clinical intervention studies within 1 month of recruitment Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Months - MaximumAge: 13 Months - StdAgeList: Child
Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol
Status: Not yet recruiting

Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth

Eligibility:
- EligibilityCriteria: Criteria The eligibility criteria were set according to the guidelines of AAPD, 2020. (4)  Inclusion Criteria:  4 -9 years old Primary molars with no spontaneous or provoked pain Primary molars with at least two-thirds of the root length were still present. Primary molars with no sign of internal or other kinds of root or bone resorption.  Exclusion Criteria:  Patients with systemic diseases (congenital or rheumatic heart disease, hepatitis, nephritis, tumor, cyclic neutropenia, leukemia, and children on long-term corticosteroid therapy). Un-cooperative patients. Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 4 Years - MaximumAge: 9 Years - StdAgeList: Child
Enteral Feeding of Fibre to Improve Microbiota
Status: Recruiting

Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any individual that has been identified for distal (stoma) feeding that is able to understand verbal and written English to provide informed consent. Participants must be undergoing ileostomy or colostomy reversal surgery.  Exclusion Criteria:  Not undergoing ileostomy or colostomy reversal. Persons who might not adequately understand verbal explanations or written information given in English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
DePTH: De-emphasize PTH
Status: Recruiting

The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >=18 years Kidney failure treated with in-center hemodialysis PTH >=150 pg/mL x 2 consecutive measures at least 1 month apart or active IV activated vitamin D treatment using the NKC protocol  Exclusion Criteria:  History of parathyroidectomy or calciphylaxis Severe secondary hyperparathyroidism (PTH >=600 pg/mL x 2 consecutive measures at least 1 month apart despite paricalcitol >=10 mcg 3x/week or doxercalciferol >=5 mcg 3x/week or cinacalcet >30 mg/d) Calcium >9.8 mg/dL Phosphate >9 mg/dL Cholestyramine, phenytoin/phenobarbital, or ketoconazole use Breast-feeding mothers Inability to provide informed consent and no legally authorized representative - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
Status: Not yet recruiting

Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  60 years of age and older Multiple chronic conditions (Functional Comorbidity Index > or = 3) Impaired physical function (< or = 8 repetitions on 30 second sit to stand test)  Exclusion Criteria:  Life expectancy < 12 months Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke) Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA)) Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina) - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Spatial Transcriptomics in Kidney Transplantation
Status: Not yet recruiting

The study is an investigator-led, prospective, longitudinal, observational cohort study.

The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology.

By utilising new spatial technologies, the investigators aim to:

Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes
Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney
Develop refinements to histological kidney rejection diagnostic and scoring classification
Correlate of spatial and refined biopsy scoring features to clinically important outcomes

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All participants included in the study must be age ≥ 18 years old at time of enrolment and  able to provide informed consent (interpreter permitted) for enrolment consenting to longitudinal follow up (can withdraw post enrolment) consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)  Exclusion Criteria:  Patients will be excluded from the study if they are  unable (or unwilling) to provide consent, or have life-expectancy less than 6-months, or have received a haematopoietic stem cell transplant in the past 5 years. - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Kidney transplant (or kidney-pancreas transplant) recipients consenting to this study. - SamplingMethod: Probability Sample
A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting
Status: Not yet recruiting

The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female. Age 18-75 years (both inclusive) at the time of signing the informed consent. Body mass index between 18.0 and 38.0 kilogram per meter^2 (kg/m^2) (both inclusive). Glycated hemoglobin (HbA1c) less than or equal to (<=) 9 percent (75 millimoles per mole [mmol/mol]) at screening.  Treated with basal insulin with or without any of the following anti-diabetic drugs/regimens with stable doses >= 90 days prior to the day of screening:  Metformin, Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors Oral combination products (for the allowed individual oral antidiabetic drugs), Injectable and oral glucagon-like peptide 1 (GLP-1) Receptor Agonists. Physically active >= 300 metabolic equivalent of task (MET) minutes/week as determined by an International Physical Activity Questionnaire (IPAQ) at screening. Mass-specific oxygen volume (VO2) peak greater than (>) 25 milliliters per kilogram per minute (mL/kg/min) as determined by cardiopulmonary testing (CPX) test at screening.  Exclusion Criteria:  Known or suspected hypersensitivity to study intervention(s) or related products. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days prior to the day of screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing
Status: Not yet recruiting

The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:

group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)
group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)

Digital impressions with iTero intraoral scanner will be performed; digital impressions will be performed after 3 months (T1) and 6 months (T2) from the baseline.

Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.

After attachments placement, the clinicians will be asked to answer, on a scale from 1 to 10, to this questionnaire's questions about the two different flowable composites; each question is repeated for each composite resin.

Type of brushing (with manual or electric toothbrush) and hand of brushing will be recorded.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients undergoing Invisalign orthodontic treatment  Exclusion Criteria:  enamel demineralizations - HealthyVolunteers: No - Gender: All - MinimumAge: 14 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult
Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa.
Status: Not yet recruiting

The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ages between 18 and 65. Have a dispositive with Internet access.  Exclusion Criteria:  None - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children
Status: Recruiting

To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The informed consent form was voluntarily signed by the legal guardians of the subjects (children aged ≥8 years should participate in the informed consent process and sign the informed consent form). Pediatric patients, whether they are outpatients or inpatients, who require oral cetirizine therapy. The children was clinically diagnosed with allergic diseases such as eczema, urticaria, asthma, and allergic rhinitis. Pediatric patients had not taken other antiallergic drugs 72 hours before screening.  Exclusion Criteria:  Abnormal liver function (ALT or AST > 2 times the upper limit of normal). Abnormal renal function (serum creatinine above the upper limit of normal or GFR < 10 mL/min) Electrolyte abnormalities (potassium or magnesium < 0.8 times lower limit of normal, > 1.2 times upper limit of normal) Children who were allergic to cetirizine or had a history of serious adverse reactions. Pediatric patients with unstable vital signs. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 16 Years - StdAgeList: Child
Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN)
Status: Not yet recruiting

Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  90 Pts with SLE that have LN in different classes. Age between 18-60 yrs.  Exclusion Criteria:  Pts with ESRD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DM and Cancer. Age below 18 yrs& above 60 yrs Pt who refused to contribute in this study - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Sample size was calculated using EPI info 2000 statistical package:- 60 patients diagnosed with LN depending on lab criteria and imaging are submitted for this study - SamplingMethod: Non-Probability Sample
Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain
Status: Recruiting

Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  With diagnoses related to chronic lower back pain Age above 18yrs Non pregnant  Exclusion Criteria:  Cancer pain - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: chronic back pain - SamplingMethod: Probability Sample
An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients
Status: Not yet recruiting

This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of SMA based on gene mutation analysis with bi-allelic survival motor neuron (SMN1) mutations (deletion or point mutations). Patients or Parent(s)/legal guardian(s) willing and able to complete the informed consent process and comply with study procedures and visit schedule.  Exclusion Criteria:  Active viral infection (includes HIV or serology positive for hepatitis B or C). Use of invasive ventilatory support (tracheotomy with positive pressure) or pulse oximetry <95% saturation. Concomitant illness and any drug that in the opinion of the investigator creates unnecessary risks for gene transfer. Clinically significant abnormal laboratory values. Participation in a recent SMA treatment clinical trial that in the opinion of the PI creates unnecessary risks for gene transfer. Patient with signs of aspiration based on a swallowing test and unwilling to use an alternative method to oral feeding. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult