rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial
Status: Recruiting

Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.

The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Infants born by planned CS, 37-42 weeks gestational age  Exclusion Criteria:  infants with significant congenital malformations influencing cardiopulmonary transition infants whose mother has gestational diabetes, pre-eclampsia, eclampsia infants where immediate cord clamping is needed due to resuscitation of the baby or mother when spontaneous contractions before the cesarean section is done. KCF will not be done to infants who will start breathing instantly after being extracted from the uterus so as not to interfere with their breathing efforts - HealthyVolunteers: No - Gender: All - MaximumAge: 30 Minutes - StdAgeList: Child
Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity
Status: Recruiting

The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.

The main question it aims to answer is:

• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?

To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To have a body mass index between 25 kg.(m2)-1 and 29.9 kg.(m2)-1 Self reported sitting time greater than 7 hours per day Not exercising regularly in the last 3 months  Exclusion Criteria:  Hypertension Coronary heart disease Heart failure Diabetes mellitus (A1C being 6.5% and above) Prediabetes (A1C between 5.7% and 6.4%) Metabolic syndrome Hypothyroidism Non-alcoholic fatty liver disease Chronic inflammatory disease Chronic renal failure Cushing's syndrome Musculoskeletal disorder that will affect the ability to do physical activity HIV infection Being on antihypertensive medication Being on lipid-lowering medication Being on antidiabetic medication Being on systemic glucocorticoid medication Smoking Pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Pre-anesthesia Imaging-based Respiratory Assessment and Analysis
Status: Recruiting

This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients undergoing general anesthesia Patients who can undergo pre-anesthetic consultation and airway examination.  Exclusion Criteria:  Patients unable to undergo pre-anesthetic consultation and airway examination. Patients requiring emergency surgery. Vulnerable populations. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing regular general anesthesia with pre-anesthetic consultation and airway examination. - SamplingMethod: Non-Probability Sample
Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve
Status: Recruiting

The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:

-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?

Participants will:

undergo either traditional or orthodontic extraction
be monitored for postoperative paresthesia.

Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Presence of indication for wisdom tooth extraction for reasons such as pericoronitis, pathological formation, orthodontic reasons, caries, etc. Mandibular impacted wisdom teeth close to the inferior alveolar nerve  Exclusion Criteria:  Mandibular impacted wisdom tooth not close to inferior alveolar nerve Wisdom tooth whose apexification has not yet been completed Suspicion of a malignant pathological lesion Pathological lesion associated with inferior alveolar nerve Presence of an acute infection - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study
Status: Not yet recruiting

A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 or older Able to read, write and speak English or French (non-English or French speaking patients may participate if appropriate translation is used) Able to provide informed consent Diagnosed with Myelodysplastic Syndrome using WHO 2022 criteria (12) Ability to wear the OURA ring and operate the associated smart-phone app, and willing to adhere to the study regimen Willing to operate and charge a smart phone loaded with the OURA ring app  Exclusion Criteria:  Performance status ECOG > 3. Cognitive or physical impairment preventing the usage or utilization of the OURA ring and smart phone. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Our study population is in adult patients with MDS. There are no limitations with regards to age or gender. - SamplingMethod: Non-Probability Sample
Clinical Validation of BBCT-hip
Status: Recruiting

The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  caucasic post-menopausal women resident in Emilia-Romagna menopause (>= 45 years)  Exclusion Criteria:  tumours not free living Chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / Paget bone / rheumatoid arthritis. Neurodegenerative diseases Long-term continuous therapy (>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors Previous femur fractures Presence of hip/knee prosthesis  only for the fracturegroup:  presence of fixation devices after the fracture femur fracture due to high energy trauma - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 65 Years - MaximumAge: 85 Years - StdAgeList: Older Adult - StudyPopulation: Resident in Emilia Romagna, Italy - SamplingMethod: Non-Probability Sample
ICG Anastomotic Control in Digestive System Surgery
Status: Recruiting

This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  elective setting of surgery digestive system surgery for benign or malignant pathology 30 days of post-operative follow-up at least available from medical documentation primary colo-colic or colo-rectal anastomosis with or without preventing ostomy more than 18 years old, less than 90 years old  Exclusion Criteria:  terminal colonic stoma without anastomosis creation after demolitive step extended transverse right hemicolectomy left hemicolectomy with high vascular ligation associated bowel or another splanchnic resection (i.e. neoplastic infiltration) previous colic surgery synchronous neoplasm not reporting in operating form details about vascular ligation lack in reporting in medical records of primary outcomes stage IV cancer ASA IV less than 18 years old, more then 90 years old emergency setting - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: A consecutive series of patients underwent digestive system surgery at our institution between January 1, 2018, and July 31, 2023 - SamplingMethod: Probability Sample
Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population.
Status: Recruiting

OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efﬁcacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.

PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.

COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:

iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).
iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).
MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parent of a 6 to 18 years old child Written informed consent Understanding Catalan Pre-intervention assessment complete  Exclusion Criteria:  None - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy
Status: Recruiting

This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  - Has a definitive diagnosis of DMD prior to Screening based on documentation of clinical findings and confirmatory genetic testing.  Among participants recruited from routine clinical practice:  Is aged 4 through 5 years at the time of enrollment. Is ambulatory per protocol specified criteria. Is currently receiving or has been prescribed to start chronic glucocorticoid therapy at the time of this observational study enrollment.  For Delandistrogene Moxeparvovec-exposed Participants:  - Will be initiating usual care treatment with delandistrogene moxeparvovec at the time of study enrollment.  For Comparators:  - Is unexposed to DMD gene therapy at the time of study enrollment.  Exclusion Criteria:  Among participants recruited from routine clinical practice:  Has any deletion of exon 8 and/or exon 9 in the DMD gene. Is currently participating in any DMD interventional study at the time of this observational study enrollment.  Has a medical condition or confounding circumstances (for example, prior traumatic limitation for mobility or significant behavioral comorbidity) that, in the opinion of the Investigator, might compromise:  The participant's ability to comply with the protocol-required procedures, The participant's wellbeing or safety, and/or The clinical interpretability of the data collected from the participant.  Other inclusion/exclusion criteria may apply. - HealthyVolunteers: No - Gender: Male - MinimumAge: 4 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: DMD participants within each prescriber's practice who either (1) have been prescribed delandistrogene moxeparvovec or (2) are receiving or have been prescribed to begin chronic glucocorticoid therapy in routine clinical practice, and who meet the study eligibility criteria, will be invited to enroll into the study and will be followed according to the protocol. - SamplingMethod: Non-Probability Sample
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
Status: Recruiting

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory [primary resistance]) or relapsed [secondary resistance]) after at least 3 months from the start of treatment with pembrolizumab.

The study will consist of 2 main parts:

Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design
Part 2: Dose-expansion cohorts using Simon's 2-stage design

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Has histologically or cytologically confirmed advanced solid tumor Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab. At least 1 measurable lesion, as defined by RECIST v1.1 Estimated survival of ≥3 months No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)  Exclusion Criteria:  Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab Previous treatment with pembrolizumab <21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095 Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095 Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095 Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095 Received a cell therapy within the last 12 months prior to the first dose of PLN-101095 Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases) Pregnant or lactating female participant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Carotenoids for Collision Athletes
Status: Not yet recruiting

This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Collision sport athletes:  Penn State student ages 18 and over Any gender Participating in club, or intramural collision-sports and is willing to participate in this study (examples: hockey, lacrosse, soccer, wrestling, rugby, boxing, basketball, cheer).  Exclusion Criteria:  For all subjects:  Subjects with concurrent injury that would impair their ability to perform the assigned procedures will be excluded. Under 18 years of age. Not a Penn State Student Not participating in a collision sport. Diagnosis of a learning disability impacting their capacity to consent. History of ocular or neurological disease (glaucoma, macular degeneration, MS, Parkinson's) Concussion diagnosis within the last calendar year. However, if a subject sustains a concussion during the course of the study, they may remain as an active participant if they wish to do so. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effects of Exercise Training in Survivors of Lymphoma
Status: Not yet recruiting

This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria Lymphoma participants:  Listed in relevant registers Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma) Completed treatment in the past two to five years without relapse or second cancer Previous anthracycline treatment with or without mediastinal radiation No severe cancer-related fatigue (per self-report)  Inclusion Criteria Lymphoma participants and non-cancer reference group:  Currently not performing >75 minutes/week of aerobic exercise Willing and able to adhere to all study procedures.  Exclusion Criteria Lymphoma participants:  Relapse since diagnosis A history, or current presence, of another diagnosis of invasive cancer of any kind  Exclusion Criteria Lymphoma participants and non-cancer reference group:  Presence of any uncontrolled- or recent cardiovascular disease Has undergone heart surgery Uses a pacemaker Pregnancy Unable to read and understand Swedish (applicable for the Swedish site only) Unable to read and understand Norwegian (applicable for the Norwegian site) Any physical or mental health condition restricting adherence to study protocol - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery
Status: Recruiting

The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18-75 Patients with Glasgow Coma Scale of 15. American Society of Anaesthesiologists (ASA) Physical Status Classification I - II patients Scheduled for elective, open microscopic lumbar surgery (less than 3 levels) under general anesthesia.  Exclusion Criteria:  Cognitive impairment Patient refusal Weight<50kg, >120kg Allergy to local anesthesia Alcohol/ drug abuse Renal failure or liver failure Coagulopathy/thrombocytopenia Chronic pain with chronic opioid usage Ischemic heart disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Increasing Physical Activity for Adults With Multiple Sclerosis (MS)
Status: Recruiting

This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Provider-confirmed diagnosis of MS using revised 2017 McDonald criteria > 18+ years of age Patient determined disease steps (PDDS) score < 3, indicating the potential for some gait disability although typically ambulates without an assistive device Insufficiently active, defined as < 150 minutes of physical activity per week, assessed using the PAVS in the EHR in clinics as part of the routine patient intake process Use of an iPhone with software version iOS13+ or an Android phone 4.1+ Agree to install and use the ExerciseRx app for the entire study period and keep their phone on them during the daytime (e.g., pocket, bags, hands)  Exclusion Criteria:  Recent (past 4 weeks) or planned surgery during the study period which may impact engaging in step counts MS relapse within the last 30 days Plans to travel internationally during the study period, which could interfere with server uploads of mobile phone data Those at a higher risk of falling or injury from falls or unable to safely exercise due to other medical conditions (e.g. heart conditions, diabetes or conditions made worse by walking or physical activity) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult