rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Study of 23ME-01473 in Patients With Advanced Solid Malignancies
Status: Not yet recruiting

This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Phase 1: Adults ≥ 18 years of age Phase 1: Histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type. Adults 18+: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy ≥ 12 weeks Phase 1: Participants with evaluable disease are eligible regardless of tumor type, RECIST 1.1 can be used to assess disease progression.  Exclusion Criteria:  Females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding.  Immune-Related Medical History  Active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years Receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis History of Grade ≥ 3 immune-mediated toxicity Prior allogeneic or autologous bone marrow transplant, or other solid organ transplant  History of a positive test for:  Hepatitis C virus (HCV) infection, except for those who have completed curative therapy for HCV and have undetectable HCV RNA Hepatitis B virus (HBV) infection, except for those who are receiving treatment with HBV-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable HBV DNA Human Immunodeficiency Virus (HIV) infection, except those who meet the following criteria: CD4+ T cells ≥ 350 cells/μL, no history of Acquired Immunodeficiency Syndrome (AIDS)-defining opportunistic infections, HIV RNA < 50 copies/mL, and on a stable antiretroviral regimen for at least 3 months Prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter) History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Uncontrolled or symptomatic CNS (central nervous system) metastases and/or carcinomatous meningitis Recent history (within 6 months) of serious cardiovascular disease - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 110 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control
Status: Not yet recruiting

This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with type II diabetes mellitus aged 19 years or older Patients who had taken DA5221-B1 and DA5221-B2(or another DPP-4 inhibitor is allowed) combination therapy at the same dose for at least 8 weeks prior to the screening visit Patients with fasting plasma glucose≤270mg/dL at the screening visit Patients with 18.5kg/m^2≤BMI≤40kg/m^2 at the screening visit Patients who have signed an informed consent themselves after receiving detailed explanation about the clinical study  Exclusion Criteria:  Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic coma or -pre-coma, metabolic acidosis including lactic acidosis and diabetic ketoacidosis Patients with a medical history of New York Heart Association(NYHA) class III~IV heart failure or with congestive heart failure, acute and unstable heart failure Patients with severe infectious disease or severe traumatic systemic disorders Patients with hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia Patients with galactose intolerance, lapp lactase deficiency, glucosegalactose malabsorption - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
Status: Recruiting

The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.

The main questions it aims to answer are:

Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?

Participants will be randomized stratified by age (≤ 67 years, > 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Waiting list for primary unilateral knee replacement surgery Osteoarthritis of the knee being the primary reason for surgery Reside within 60 minutes of travel to the site of the intervention, and being able to participate fully  Exclusion Criteria:  Previous knee replacement surgery in the other knee Other reason than osteoarthritis of the knee as the primary reason for surgery Revision surgery Impaired cognitive function Not being independent speaking and reading in swedish language Chronic illness or disability etc hindering full participation in the intervention - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography
Status: Not yet recruiting

Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  any patient ventilated invasively any patient ventilated non-invasively  Exclusion Criteria:  age under 18 - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: mechanically ventilated patients - SamplingMethod: Non-Probability Sample
Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project)
Status: Recruiting

The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children with congenital or acquired brain injuries and/or neurodevelopmental disabilities Aged from 4-18 years old MACS < 5 Cognitive functioning allowing an adequate understanding of the proposed activities and cooperation in exercises investigated by appropriate rating scales (WPPSI-III or WPPSI-IV or WISC-IV or WAIS-IV or LEITER-R or LEITER-3 or RAVEN Matrices). Distance from the clinical center in order to permit periodic in-person assessments Internet access Parents or legal guardians able to commit to and cooperate in an intensive home-based rehabilitation program.  Exclusion Criteria:  Severe comorbidities and/or severe cognitive disability - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Arterial Wall Shear Stress After Intracranial Artery Recanalization
Status: Recruiting

There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals aged 18 years and above Presenting with acute neurological impairments and demonstrating occlusion of major cerebral arteries (inclusive of one or more of the internal carotid artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, vertebral artery, or basilar artery) as evidenced by brain MRA examinations Arterial recanalization subsequent to interventions such as intravenous thrombolysis and/or endovascular thrombectomy. Verification of the recanalized arteries on subsequent brain MRA imging Availability of source images from intracranial TOF-MRA (stored in DICOM format) both before and after arterial recanalization  Exclusion Criteria:  Absence of TOF-MRA imaging either before or after arterial recanalization Brain MRI was performed, but TOF-MRA (DICOM source images) are missing Image analysis is deemed challenging due to the quality of the Brain MR images Intervention for vascular recanalization was unsuccessful, or re-occlusion was observed in the follow-up brain MRA - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who presented to a medical center with acute neurological deficits and were confirmed to have acute occlusion in a major cerebral artery. - SamplingMethod: Probability Sample
Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.
Status: Not yet recruiting

This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3. Age is between 7-30. Participants who are willing to participate in the study and sign the informed consent.  Exclusion Criteria:  Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination. Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition. Cases requiring long-term use of proton pump inhibitors due to their physiological conditions. Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases, will affect the evaluation of treatment results. Severe mental illness, such as schizophrenia, bipolar disorder, etc. Those who used probiotics one month before the case may affect the intestinal flora. Pregnancy. Cases that cannot understand the content of this research. Participants who are unwilling to participate in the study or refuse to sign the informed consent. Participants who are not suitable to include in this study, evaluate by PI or Co-PI. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult
PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients
Status: Recruiting

Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.

A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.

PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  • All gender COPD patients  Age will be 55-65 years. Moderate to severe COPD patients emphysema on CT scan (HU ≥ - 900) Their FEV1 will be less than 80% predicted Class II obesity (BMI of 35 to < 40) Medically stable greater than 10 pack-year smoking history  Exclusion Criteria:  • Very severe COPD - Lung cancer  Lung resection - Lung fibrosis Heart failure - Cognitive disorders that affect the device application Musculoskeletal or neurological disorders that interfere with an exercise program requiring invasive or non-invasive positive pressure ventilation inability to speak in complete sentences due to breathlessness suspected elevated intracranial pressure - hemodynamic instability recent facial, oral, or skull surgery active hemoptysis (more than two tablespoons of frank blood per day) pneumothorax - failure to comply with the research protocol. uncontrolled hypertension, or other concomitant respiratory diseases participate in any research or pulmonary rehabilitation program during the period of this study. imaging changes of lung disease such as occupancy, exudation, and interstitial changes on CT scan - HealthyVolunteers: No - Gender: All - MinimumAge: 55 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
Status: Not yet recruiting

The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older, and loss of olfactory function for more than 6 months after head trauma  Exclusion Criteria:  pregnant or lactating women, patients with compromised immune function, patients with acute or chronic sinus infection, patients with nasal polyps, patients with a history of sinonasal cancer, and patients with low platelets or hemophilia and other blood and blood cell-related diseases - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
PREVENT HPV-Related Cancers
Status: Not yet recruiting

This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parents/Caregivers (P/C) of children/adolescents (C/A) ages 9-17 years of age (i.e., age-eligible for HPV vaccination); P/C with active clinic patients (i.e., have been seen in the clinic in the last 12 months); and P/C who speak either English or Spanish.  Exclusion Criteria:  P/C of C/A with previous excluding HPV vaccination history (e.g., completed vaccination, or not due); P/C of C/A with clinical conditions that influence the CDC HPV vaccination recommendations (e.g., pregnancy); P/C of C/A with other factors that would influence CDC HPV recommendations; and P/C that does not speak Spanish or English. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery
Status: Recruiting

Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults (≥18 years) BLOODS score ≥3 as calculated by surgeon High preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen/pelvis Planned for exploratory laparotomy and PCS Preoperative hemoglobin concentration ≥10 mg/dl within 30 days of registration Patients scheduled for PCS, with or without other planned procedures  Exclusion Criteria:  A history of active coronary artery disease  o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 30 days of operation.  A history of cerebrovascular disease A history of congestive heart failure A history of uncontrolled hypertension A history of restrictive or obstructive pulmonary disease A history of renal dysfunction (Cr >1.6 mg/dl) Abnormal coagulation parameters (INR >1.5 not on coumadin, or platelet count <100,000 mcL) Presence of active infection Evidence of hepatic metabolic disorder (bilirubin >2 mg/dl, ALT >75 U/L in the absence of biliary tract obstruction) Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery Refusal to accept allogenic or autologous blood transfusion - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Healing Lodge First Face Training Evaluation Study
Status: Not yet recruiting

The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.

To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Employment at the Healing Lodge of the Seven Nations Selection to participate in First Face for Mental Health training  Exclusion Criteria:  ° Previous completion of First Face for Mental Health training - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult