rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke
Status: Recruiting

To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease; patients with relatively stable vital signs, with a NIHSS score of 21 points; patients with tracheotomy accompanied by dysphagia; no previous history of dysphagia; age ≥ 30 years and ≤80 years; informed consent signed by the patient and his family.  Exclusion Criteria:  patients with medullary haemorrhage/infarction; patients that experienced cerebral hernia and recurrent stroke; patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment; patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour; patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease; patients with a history of epilepsy or risk of seizures. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns]
Status: Recruiting

The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:

radiological and pathological response rate to three doses of antiPD1 agents;
do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.

After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 18 years and older. Performance status according to the Eastern Cooperative Oncology Group (ECOG) of 0-1. Patients who have not previously received immunotherapy with anti-PD1, anti-PDL1, or anti-CTLA4 agents. Clinical stage III (B-D), i.e., with clinically or radiologically determined metastatic changes in lymph nodes. Histologically confirmed involvement of regional lymph nodes. Lesions assessable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.  Exclusion Criteria:  Patients with melanoma of non-skin localizations. Patients with active autoimmune diseases. Patients with active infectious diseases. Patients with severe concomitant diseases with an ECOG status &gt;1. Pregnant or lactating patients. Patients requiring the intake of glucocorticoids at a dose greater than 10 mg of prednisone (or equivalent) per day. Patients requiring the use of, or having received, systemic antibiotics within 4 weeks prior to the start of the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: No specific requurements to study population - SamplingMethod: Probability Sample
Comparison of Detection Rates Between Two Commonly Used Bone Density Measurement Methods
Status: Not yet recruiting

72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient.

Record the patient's age, gender, height, and weight; Review the patient's past medical history (especially whether there is a history of brittle fractures, whether there is a history of using drugs that affect bone metabolism, etc.).
Retrieve the bone density values of the anterior lumbar vertebrae 1 to 4 measured by GE Healthcare Lunar Prodigy dual energy X-ray absorptiometry from the database, and take the average (DXA bone density value). According to the diagnostic criteria of the Diagnosis and Treatment Guidelines for Primary Osteoporosis (2022), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
Identify the lumbar spine bone density values (QCT bone density values) measured by the GE Gemstone CTHD750 CT instrument from the database. According to the diagnostic criteria of the Chinese Quantitative CT (QCT) Diagnosis Guidelines for Osteoporosis (2018), determine whether the patient has normal bone mass, decreased bone mass, or osteoporosis.
Statistical analysis was conducted on the normal bone density, bone loss, and number of osteoporosis diagnosed by DXA and QCT respectively, in order to explore the differences in the detection rates of osteoporosis between these two monitoring methods. The data was analyzed and processed using SPSS 21.0 statistical software, and the count data was expressed as a rate (%) χ 2-test, P<0.05 indicates statistically significant difference; Explore whether the difference in detection rates between the two is related to factors such as weight; Calculate the detection rates of osteoporosis using two detection methods in patients who have experienced brittle fractures, and preliminarily determine which detection method is more accurate in determining osteoporosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adults aged 18 and above, regardless of gender The interval between DXA and QCT examinations shall not exceed 3 months.  Exclusion Criteria:  Individuals with other metabolic and bone diseases causing focal bone destruction of the vertebral body Incomplete key information - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 72 adult patients who underwent lumbar spine anteroposterior DXA and QCT examinations at Qianfoshan Hospital in Shandong Province from January 2019 to December 2022 were selected, with an interval of no more than 3 months between the two examinations for the same patient. - SamplingMethod: Non-Probability Sample
Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer
Status: Recruiting

This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.

The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.

The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients must be at least 18 years of age and able to give written informed consent and comply with study procedures; Clinical diagnosis: breast cancer, metastatic form; Oligo-metastatic disease as determined by standard of care diagnostics, limited to 5 total individual distant metastases, either in one organ or in 2-3 organ systems. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as single lesion; Possibility of complete elimination of all foci; HER2 expression level of 3+ points according to immunohistochemical analysis (IHC) and/or degree of amplification ≥2.0 according to the results of in situ hybridization (ISH); Patients with stable metastatic brain foci for at least 4-6 weeks (according to MRI); Patients with HER2+ inoperable locally advanced or metastatic breast cancer who previously received taxanes and trastuzumab; ECOG 0-1 status; Life expectancy of more than 6 months.  Exclusion Criteria:  T-DM1 therapy in the medical history; Autoimmune diseases in the medical history or treatment of exacerbations during the last three months; Uncontrolled brain metastases and/or carcinomatous meningitis, causing neurological symptoms; Primary multiple malignant tumors: other malignant neoplasms requiring active treatment; Acute myocardial infarction, acute cerebrovascular accident, uncorrectable coagulopathy, decompensated concomitant pathology, infectious diseases in the active phase, ECOG status > 2; Pregnancy, lactation. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effectiveness of a Single Dose of Betamethasone in Children With Symptomatic Adenovirus Infection
Status: Not yet recruiting

The goal of this double-blind, Placebo-controlled Randomized Study is to assess if a single dose of betamethasone in children with febrile adenoviral infection works well in achieving an early fever regulation.

The experimentation is conducted to answer this question: "Can betamethasone help reduce fever more quickly in a child with viral adenovirus infection? "The secondary objective is to assess if the child's overall clinical conditions improve more rapidly (reduced sore throat, quicker return to regular eating) and a reduction in the incidence and duration of hospitalizations.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Body Temperature measured with an axillary or ear thermometer >= n 37.5°C, persisting for a minimum of 6 hours and a maximum of 5 days. Clinical presentation consistent with pharyngo-tonsillar infection by Adenovirus, including At least one of the following symptoms: pharyngodonidae /asthenia/nausea/vomiting/diarrhea/cough/rhinorrhea/abdominal pain/otalgia and at least one of the following signs: pharyngeal hyperemia with or without pharyngo-tonsillar exudate/inflammation of the upper or lower airways/lymphadenopathy/skin rash.- Positive result on the antigen test for Adenovirus performed with the "Biosensor" rapid swab. Negative result on the swab for Group A Streptococcus (SBEGA), if deemed necessary following McIsaac criteria Informed consent form for participation in the study signed by the parent(s) or legal guardian.  Exclusion Criteria:  Adequate dosage of betamethasone in the 48 hours prior. Underlying chronic illness associated with an increased risk of unusual or severe adenoviral infection. Inability to tolerate oral medications. Documented allergy or any other known contraindication to Bentelan 0.5mg® medication.-Patients on chronic therapy with anticholinesterases, salicylates, nonsteroidal anti-inflammatory drugs, thiazides, furosemide, amphotericin, xanthines (theophylline), antidiabetic drugs, insulin, cyclosporine, ritonavir, ketoconazole, acetylsalicylic acid, phenytoin, phenobarbital, ephedrine, rifampicin, anticoagulants. Subacute or chronic conditions requiring a higher equivalent dose of betamethasone or known primary or secondary adrenal insufficiency. Transfer to another hospital for any reason. Parents who are unable to understand the proposed study or cannot reliably participate in phone follow-up due to significant language barriers. Participation in another study involving an experimental drug within the 30 days prior to and during the current study. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 6 Years - StdAgeList: Child
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Status: Recruiting

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice.

Primary objective of the study:

- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus;

Secondary objectives of the study:

description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus;
assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes;
assess the relationship between the characteristics of patients and the time to the onset of cancer.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Legal age Diagnosis of type 2 diabetes mellitus  Exclusion Criteria:  Diagnosis of cancer before diagnosis of type 2 diabetes Diagnosis of diabetes secondary to other diseases Diagnosis of diabetes secondary to other drugs Diagnosis of diabetes following surgery - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 779 patients with diabetes mellitus type 2 and with at least 18 years old. - SamplingMethod: Probability Sample
Emergency Care at Home
Status: Recruiting

This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age >= 18 years Resides within Home Hospital geographic area Lives in permanent housing (i.e., not in temporary housing such as a shelter) Patient of a Mass General Brigham primary care provider Primary care provider attests that their triage recommendation is the emergency department Emergency care at home nurse triages the participant to the emergency department or urgent care Patient attests that they intend to go to the emergency department  Exclusion Criteria:  Insurance: workers compensation and motor vehicle accident Lives in a healthcare facility (Skilled Nursing, Rehab, long term acute care) Patient/caregiver cannot answer phone or door Active substance use Acute psychiatric concerns (e.g., suicidal ideation, even if passive) Home safety concerns (e.g., intimate partner violence) High-risk features:  oHigh Risk Signs, if available: Heart rate > 120 Systolic blood pressure < 90 Shock Index (heart rate divided by systolic blood pressure) > 1 Oxygen < 93% on ambient air Increase in oxygen requirement new or > 2 liters Respiratory rate > 28 Diaphoresis oHigh Risk Symptoms: Active chest pain Severe work of breathing Syncope Hemoptysis Seizure Other concerning symptom per nurse triage  Requires inpatient-level care Requires specialty consultation Requires physical, occupational, or speech therapy Requires blood transfusion Requires internal physical exam maneuver (e.g. rectal exam, genitourinary exam) Requires imaging that is not available at home Requires monitoring that is not available at home Troubleshooting wound vacs - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications
Status: Not yet recruiting

BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists, Availability of FFPE tumor tissue, archival or newly obtained, Measurable disease as defined by RECIST Version 1.1, Adequate hematologic function, Adequate hepatic and renal function, Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1, Other inclusion criteria per study protocol.  Exclusion Criteria:  Prior exposure to a selective RNR inhibitor (Note: Prior exposure to chemotherapies with nonselective RNR inhibitory activity e.g., gemcitabine is permitted), Receipt of any approved or considered standard of care anticancer drug(s) or biological product(s) within 4 weeks or 5 half-lives, Hematologic malignancies, Primary CNS malignancy, leptomeningeal disease, or symptomatic active CNS metastases, with exceptions per study protocol, Prior or concurrent malignancies, with exceptions per study protocol, History of HBV, HCV, or HIV infection, Clinically significant cardiac condition, Active or history of interstitial lung disease (ILD) or pneumonitis, or history of ILD or pneumonitis requiring steroids or other immunosuppressive medications, QTcF > 470 msec, Concurrent use of strong inhibitors or inducers of CYP3A, CYP2C8, CYP2C9, or CYP2C19, Other exclusion criteria per study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
Status: Not yet recruiting

This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women with exposure to efgartigimod any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days. Written informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written informed assent or eConsent by the pregnant minor (where applicable) and written informed consent or eConsent by the parent/legal guardian).  Exclusion Criteria:  None - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pregnant women or women no longer pregnant at the time of study enrollment but exposed to efgartigimod any time within 25 days prior to conception or any time during the pregnancy. - SamplingMethod: Non-Probability Sample
Comparison of Airway Management With Bronchial Blocker and Double-Lumen Tube in Single-Lung Ventilation
Status: Recruiting

In this study, the primary aim is to compare the impact of using a double-lumen tube and bronchial blocker for single-lung ventilation in patients undergoing minimal invasive cardiac surgeries on postoperative pulmonary functions. Secondary objectives include the comparison of application duration, success in lung collapse, and the number of repositioning attempts for both techniques.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients planned for on-pump minimal invasive cardiac surgical procedures requiring single-lung ventilation Female and male patients aged 18 and above Patients with ASA scores of 1-2-3 Patients with signed informed consent to participate in the study Patients with a Body Mass Index (BMI) less than 40  Exclusion Criteria:  Emergency surgeries Patients with ASA scores greater than 3 Advanced-stage organ (heart, kidney, liver, lung) failure Advanced lung diseases (COPD, FEV1<50%, restrictive lung diseases, history of chest surgery, Pulmonary Hypertension, PAB>30mmHg) Patients with anticipated difficult intubation Pregnant individuals Patients with a BMI greater than 40 Patients lacking the ability to read, understand, sign the informed consent form, and those who do not wish to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents
Status: Not yet recruiting

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ten to 19 years of age at the point of inclusion A minimum of 12 months since the last chemotherapy with no upper limit Ability to understand the physical intervention and general participant advice  Exclusion Criteria:  Participation in another research study that includes similar treatment Pregnancy Cardiac arrhythmia during exercise Psychological disorders interfering with treatment Presence of a clinical condition that needs immediate treatment Planned surgeries within the subsequent 12 months that may interfere with performing exercises Any contraindications to performing physical exercise as evaluated by the recruiting medical doctor - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult