rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Status: Recruiting

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Have completed the last dosing visit of the prior OMS906 PNH study. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906. Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug. Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study. Have provided informed consent  Exclusion Criteria:  Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period. Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis. Pregnant, planning to become pregnant, or nursing female patients. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension. Unable or unwilling to comply with the requirements of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy
Status: Not yet recruiting

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study  Exclusion Criteria:  patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 65 patient with previous upper abdominal surgery either for obesity or other diseases revisional bariatric procedures - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Medial Rectus Fenestration vs Recession for PAET
Status: Recruiting

This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET.

All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD.  Exclusion Criteria:  convergence excess esotropia. paralytic or restrictive strabismus. previous strabismus surgery neurologic, ocular, or developmental disorders or follow-up less than 6 months - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test
Status: Recruiting

The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  first or second year students at the institutions's School of Allied Health Professions healthy female  Exclusion Criteria:  participating in another research study current knee pain or pathology on the dominant leg known diagnosis of vestibular impairment known pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
The Pattern of Dry Eye Disease After Cataract Surgery
Status: Recruiting

This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon. Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others). Patients who previously did not undergo any ophthalmic surgery.  Exclusion Criteria:  Patient expressed his wish to not participate in the study or discontinue it when already enrolled. Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining. Glaucoma. Diabetes mellitus. Systemic connective tissue disease, autoimmune disease. Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction. Patients who underwent refractive surgery (LASIK or PRK). Contact lens users. One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement. Patients who are already regularly using topical drops or ointments. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Participation in this study is voluntary. Research participants will be recruited during a routine visit to an ophthalmologist at Lithuanian University of Health Sciences Hospital Kaunas Clinics, Ophthalmology Department. - SamplingMethod: Non-Probability Sample
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
Status: Not yet recruiting

Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.

Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.

In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are >75 years. Despite these circumstances guidelines on patient-selection are lacking.

Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.

The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent Age ≥18 years Signed written informed consent  Exclusion Criteria:  Not able to understand the Swedish or English language Other diagnosis than ovarian cancer on final pathology - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Internet-based Behavioral Intervention Following ACS
Status: Not yet recruiting

The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina [UA]) Age 18 and older Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18 Able to read and write in Swedish  Exclusion Criteria:  Heart failure New York heart Association class IV or ejection fraction ≤ 30% Significant valvular disease Planned coronary artery bypass surgery or percutaneous interventions Any medical restriction to physical exercise Severe medical illness or an acute health threatening disease (e.g., cancer) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide Alcohol or substance use disorder that would impede ability to complete study protocol Ongoing psychological treatment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players
Status: Not yet recruiting

Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between the ages of 18-25 Not having had a lower or upper extremity injury in the last 3 months Not having had surgery in the last 6 months Playing amateur football regularly for at least 1 year  Exclusion Criteria:  Orthopedic, neurological, rheumatological or cardiorespiratory health problems that would prevent them from performing the tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult
High-resolution Intra-operative PSMA PET-CT in Prostate Cancer
Status: Not yet recruiting

This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .

The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male patient, 18 years of age or older. Patient is confirmed with high risk prostate cancer. Patient is indicated to undergo radical prostatectomy and ePLND. Patient is estimated compliant for study participation by the investigator. Patient has freely given his/her informed consent to participate in this study.  Exclusion Criteria:  Patient has general or local contra-indications for radical prostatectomy. Patient has active viral or fungal infection. Patient previously received radiotherapy of the prostate. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) according to the European Association of Urology (EAU) guidelines. - SamplingMethod: Probability Sample
S-ADHF：Sarcopenia in Patients With ADHF
Status: Not yet recruiting

This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue. At least two of the signs of heart failure (HF):  Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.  Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).  Peripheral edema. Elevated B-type natriuretic peptide (>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (>300 pg/ml).  Willingness to provide informed consent and cooperate with the follow-up  Exclusion Criteria:  Unable to understand and comply with protocol or to give informed consent End-stage diseases other than heart failure, life expectancy <1 year, such as malignant tumors Current or planned participation in a clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minmum of of 195 cases each for patients with and without sarcopenia - SamplingMethod: Non-Probability Sample
REFLECT Scoliosis System Post Approval Study
Status: Not yet recruiting

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of progressive idiopathic scoliosis Preoperative major Cobb angle 30°-65° Preoperative flexibility to ≤30° on side bending radiograph (left or right) Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8 Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging Failed or intolerant to bracing Signed informed consent and/or assent forms specific to this study  Exclusion Criteria:  Prior spinal surgery at the level(s) to be treated Documented poor bone quality, defined as a T-score of -1.5 or less Presence of any systemic infection, local infection, or skin compromise at the surgical site Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
GENETIC VARIABILITY TO GLP1 TREATMENT
Status: Recruiting

The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events.

Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit:

Informed consent
Study eligibility (Inclusion / Exclusion criteria)
Collection of demographic data (age (date of birth), gender, ethnic origin)
General and T2DM medical history review (per subject file)
Concomitant medication review (at enrollment)
Physical attributes (Body Weight, Height, BMI)
Allocation to study cohort and study subgroup
Saliva and blood collection for genetic tests
Self-reported questionnaire for Ozempic (Semaglutide) experience

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with type 2 diabetes (for participant in Cohort A) or Obese (for participant in Cohort B) and treated with Ozempic (Semaglutide) S.C. injection for at least 24 weeks. Subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment. Subject BMI above 30 kg/m2 at treatment initiation. Subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure. Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.  Exclusion Criteria:  Subject falls under contraindications to Ozempic (Semaglutide) label Subject known or suspected for hypersensitivity to any GLP-1RA or related products, or allergic constitution Subjects suffers from any other condition affecting body weight. Subject with history of chronic or acute pancreatitis Subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening. Presence or history of malignant neoplasm within 5 years prior to screening day. Subject suffers from any renal impairment (Cr > 2 mg/dl). Subject suffers from any impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit). Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol. Subject is a female who is pregnant, breastfeeding or intends to become pregnant or is of child bearing potential without medically acceptable methods of contraception. Participation in another clinical study in prior 4 weeks. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Status: Not yet recruiting

Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.

The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women and men of legal age With or without TMDs symptoms and With or without self-reported jaw fatigue when eating  Exclusion Criteria:  Subjects treated with any type of treatment requiring infiltration of the mandibular region Participants undergoing dental interventions in the last 3 months Individuals missing two or more teeth in the same quadrant. Inability to understand or speak catalan, spanish or english. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Residents from the Central region of Catalonia, and patients from the Hospital Sagrat Cor of Barcelona. - SamplingMethod: Non-Probability Sample