rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study of HC006 in Subjects With Advanced Solid Tumors
Status: Recruiting

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion) Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts. Life expectancy ≥12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Have adequate organ function as described in the protocol. Agree to adopt effective contraceptive measures.  Exclusion Criteria:  Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug. Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug. Use of any live attenuated vaccines within 28 days. With primary central nervous system (CNS) tumors or unstable CNS metastases. Have active or history of autoimmune disease or immunodeficiency disease. With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. With any mental or cognitive impairment that may limit their understanding, implementation. Major surgery within 4 weeks of study drug administration. Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma. Women who are pregnant or breastfeeding. Other protocol defined exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.
Status: Not yet recruiting

The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.

As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects from 18 to 65 years Sexually active Signed consent form  Exclusion Criteria:  Diagnosed diseases. Severe previous psychiatric conditions. Medical contraindications that prevent the use of non-invasive neuromodulation therapy. Having exercised in the hours prior to the NESA treatment. Having consumed coffee or tobacco in the hours prior to the treatment. Minors. Individuals who have previously received any type of neuromodulation treatment. Cancer. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke
Status: Recruiting

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  chronic stroke (> 6 months post-stroke) been prescribed an AFO by a clinician have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1).  Exclusion Criteria:  Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Effect of Obesity on Extracellular Matrix Composition
Status: Recruiting

The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.

The main questions to answer,

- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Healthy men aged [18,35] and BMI [20,25] Obese men aged [18,35] and BMI [30,40] Healthy older men aged [60,75] and BMI [20,25]  Exclusion Criteria:  Present or former cardiovascular disease and chronical inflammatory disease Consumption of medications and supplements that influence substrate use at rest and/or during exercise - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)
Status: Not yet recruiting

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  be 18 years or older; have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia; have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff; not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor.  Exclusion Criteria:  have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor; have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device); are a part of a vulnerable population (e.g., pregnant, minors, prisoners). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer
Status: Recruiting

Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female aged between 18 and 75 years. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). Confirmed diagnosis of leptomeningeal metastasis according to ESMO/EANO guidelines. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. No history of severe nervous system disease. No severe dyscrasia.  Exclusion Criteria:  Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. Patients with poor compliance or other reasons that were unsuitable for this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications
Status: Not yet recruiting

The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.

The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.

The main questions this study aims to answer are:

Which of the three models is more effective in preventing falls with fractures?
What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.
What are the differences in osteoporosis treatment and medication burden?

The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.

42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.

This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 65 years or greater. Admitted to an enrolled SNF after hospitalized fracture.  Exclusion Criteria:  Non-osteoporotic fracture (e.g. facial, digital, skull, at site of tumor or infection, or due to hardware placement). Receiving hospice or palliative care at the time of screening - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Elevated Lipoprotein(a) in Hospital Staff
Status: Not yet recruiting

The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any hospital staff aged 21 and above. Family members of index cases of high elevated lipoprotein(a) can also participate in this study  Exclusion Criteria:  - Inability to provide informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Working general population - SamplingMethod: Non-Probability Sample
Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players
Status: Not yet recruiting

This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being a volleyball player Age between 14 and 40 years  Exclusion Criteria:  Presence of shoulder pain History of fracture and surgery in the shoulder girdle Presence of systemic musculoskeletal disease Presence of glenohumeral instability (Positive apprehension, relocation, or subluxation test) Pain in the cervical region with upper extremity movements Experiencing shoulder problems requiring medical treatment within the last year - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 14 Years - MaximumAge: 40 Years - StdAgeList: Child, Adult
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Status: Recruiting

Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients:  VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment)  healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)  Exclusion criteria:  Patients:  other medical implanted devices than VNS, ocular diseases  Helthy participants:  medical implanted devices, cerebral trauma, ocular disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Braining - Evaluation of Acute Effects of Physical Exercise
Status: Not yet recruiting

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.

The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Included in the retrospective study Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety and has given informed consent to participation in a Braining booster session.  Exclusion Criteria:  Severe psychiatric disorder such as mania and psychosis Medical conditions such as heart- and lung diseases where PE is contraindicated. Unable to understand written and spoken Swedish language. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy
Status: Not yet recruiting

The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2<90%, t>10s) and severe hypoxia (Spo2<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:Voluntary acceptance;Asa1-2 level;Age 18-95y;Mallampati grades Ⅰ or Ⅱ  Exclusion Criteria:  Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation; Severe cardiac insufficiency (<4mets); Patients with severe renal insufficiency (requiring dialysis before surgery); Diagnosed severe liver insufficiency; Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy; Increased intracranial pressure; Upper respiratory tract infections such as mouth, nose or throat; Fever (core body temperature >37.5 degrees Celsius); a confirmed diagnosis of pregnancy or breastfeeding; Allergic to sedatives such as propofol or equipment such as tape; Emergency surgery; Multiple trauma; SpO2 < 95% in preoperative breathing air; - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 95 Years - StdAgeList: Adult, Older Adult
Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
Status: Not yet recruiting

Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  children scheduled for foot/ankle surgery body weight > 5kg  Exclusion Criteria:  infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult
NLR and PLR Levels Following iPACK Block in Knee Arthroplasty
Status: Not yet recruiting

Effect of iPACK block on NLR and PLR following knee arthroplasty

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with ASA classification I-III Aged 20-90 years Who will be scheduled for hip arthroplasty under spinal anesthesia  Exclusion Criteria:  Patients who have a history of bleeding diathesis Take anticoagulant therapy History of chronic pain before surgery Multiple trauma patients unable to assess their pain (dementia) patients operated under general anesthesia patients having an infection in region of the procedure patient who do not accept the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis
Status: Recruiting

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients presenting with bradykinesia, combined with resting tremor and/or myotonia. Appendix CT suggested chronic appendicitis evaluated by two experienced experts. All subjects and their guardians give informed consent to the content of this study and sign informed consent. Normal coagulation function. If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment.  Exclusion Criteria:  Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism. Neuroimaging examination of presynaptic dopaminergic system function was normal. Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment. Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed. People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V. Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders. Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult