rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC
Status: Not yet recruiting

To compare the pairwise PK similarities between BAT3306, EU-Keytruda, and US-Keytruda, all administered with pemetrexed and carboplatin To compare BAT3306 + pemetrexed and carboplatin with US-Keytruda and EU-Keytruda combined + pemetrexed and carboplatin as a first line treatment to demonstrate the clinical efficacy equivalence of BAT3306 and Keytruda .

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants are eligible to be included in the study only if all the following criteria are met:  Male or female, age ≥18 years on the day of signing informed consent. Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures. Life expectancy ≥3 months. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Histologically/cytologically confirmed diagnosis of Stage IV (AJCC 8th edition) nsNSCLC. Tumors without EGFR mutation/ROS1 rearrangement /ALK rearrangement.  Exclusion Criteria:  Participant must be excluded from participating in the study if the participant:  Is pregnant or a nursing female. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. Is currently participating and receiving an investigational agent or has participated in a study of an investigational agent and received an investigational agent or used an investigational device within 4 weeks prior to administration of the first dose of study intervention.  Before the first dose of study intervention:  Had received prior systemic antineoplastic chemotherapy and targeted, biological therapy Had prior treatment with any other anti-PD-1, PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against TIGIT, IDO, PD-L1, CTLA-4, and LAG3. Has participated in any other BAT3306 study and has been treated with BAT3306. Had major surgery <3 weeks prior to first dose Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study intervention. Completed palliative radiotherapy within 14 days of the first dose of study intervention. Is expected to require any other form of antineoplastic therapy while participating in the study. and so on - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Functional Inspiratory Muscle Training in Obese Individuals
Status: Not yet recruiting

In obese individuals, increased adipose tissue and systemic inflammation play a key role in the development of cardiometabolic diseases, pulmonary system dysfunction, and many respiratory diseases. Existing research has demonstrated beneficial clinical outcomes of inspiratory muscle training or combined aerobic and resistance exercise training in obese individuals. However, this focused on the isolated effects of exercise on obesity. In the current literature, no study is evaluating the effectiveness of functional inspiratory muscle training in obese individuals.

This study aims to investigate the effects of functional inspiratory muscle training on body composition, cardiometabolic markers, functional capacity, respiratory function, respiratory muscle strength, and respiratory muscle performance in obese individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Those between the ages of 25-60 According to the World Health Organization (WHO) classification, those with a body mass index between 30-40 kg/m2 Volunteering to participate in the research  Exclusion Criteria:  According to the World Health Organization (WHO) classification, body mass index is over 40 kg/m2 Functional class III or IV according to the New York Heart Association (NYHA) classification Those with a Charlson comorbidity score of 3 and above Uncontrolled hypertension, diabetes and unstable angina pectoris Cooperative disorders, orthopedic and neurological problems that may interfere with evaluation and treatment Individuals with a history of lower extremity-related injury or surgery in the last six months Being diagnosed with diabetes and having complications such as nephropathy, retinopathy and neuropathy Those with accompanying chronic respiratory disease Those with acute infection Individuals with middle ear-related pathologies (such as tympanic membrane rupture, otitis) Those with a STOP-Bang score of 3 and above Individuals with a history of spontaneous or trauma-related pneumothorax Smokers Pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 60 Years - StdAgeList: Adult
Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine
Status: Recruiting

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.

To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Local residents aged between 3 and 17; People who signed the informed consent form and could actively cooperate with the study； Axillary body temperature of 37.0℃.  Exclusion Criteria:  Subjects who meet the contraindications and precautions specified in the vaccine instructions:  Those known to be allergic to any ingredients of this product, including eggs, excipients, gentamycin sulfate; Patients with acute disease, severe chronic disease, the acute onset of chronic disease and fever; Women in pregnancy; Patients with Leigh syndrome treated with aspirin or aspirin-containing drugs; Immunodeficient, immunocompromised, or under immunosuppressive therapy; Patients with uncontrolled epilepsy and other progressive neurological diseases, patients with a history of Guillain-Barre syndrome; And g. patients with rhinitis (with a clear diagnosis and in the onset of rhinitis). Have received other clinical study drugs or were participating in other clinical trials within 1 month before entering the cohort. Have received any influenza vaccine during this natural year before entering the study Those who have been diagnosed with influenza in this natural year before entering the study. Any condition that the investigator judged to affect the trial. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 17 Years - StdAgeList: Child
The Efficacy of Pulse Therapy in Acute Relapse in Multiple Sclerosis Patients:
Status: Not yet recruiting

This work is aimed to assess the short term effect of pulse therapy on clinical and neurophysiological course before and after pulse therapy in order to understand the possible mechanism of action of steroid therapy on RRMS patients low-dose oral treatment should also be retained for patients in whom this approach seems appropriate

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Any adult patient's clinical history and neuroimaging fulfilling revised McDonald diagnostic criteria of Multiple sclerosis in an acute relapsing episode or attack and could be providing consent for participation in the study, will be included in the study.  Exclusion Criteria:  -Any patient had an infection or febrile condition. Any patient had other co-morbid neurological or psychiatric disorders or systemic disease or had contraindications for receiving pulse therapy (high steroid dose) or showed side effects of steroids or intolerance or seizure. Any patient refuses participation in the study. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Any adult patient with clinical history and neuroimaging who is fulfilling revised McDonald diagnostic criteria of Multiple sclerosis in acute relapsing episodes or attacks and could be providing consent for participation in the study, will be included in the study. - SamplingMethod: Probability Sample
ALLOGENIC ADIPOSE-DERIVED MESENCHYMAL STEM CELLS (AMSCs) FOR EPILEPSY DURING DEEP BRAIN STIMULATION (DBS) SURGERY
Status: Not yet recruiting

This study is a non-randomized, open label, phase 1 clinical trial to evaluate the fesibility and safety of intrathalamic delivery of MSCs during standard of care DBS surgery for epilepsy.

Subjects will be screened at our outpatient clinic and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, patients will undergo a standard preoperative evaluation which includes baseline laboratory values and a high-definition MRI. Patients will then undergo a stereotactic procedure for bilateral thalamic implantation of DBS leads through the ClearPoint® system. After the thalamic target for DBS is identified, cells will be infused directly into the anterior nucleus of the thalamus previous to lead implantation.

Patients will be followed in the outpatient setting for up to a year after therapy application.

Surgical, clinical, and radiographic data will be obtained during these visits

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants ≥ 18 years of age. Participants with Drug Resistance Epilepsy as defined by the ILAE5. Participants undergoing bilateral implantation of DBS leads into the anterior nucleus of the thalamus. Adequate organ function as assessed by the following laboratory values within 3 weeks prior to admission to the study: Serum creatinine and urea < 2 times the upper limit of normal; ALT, AST and alkaline phosphatase < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL; Prothrombin time ≤ 1.5 times upper limit of normal; INR and PTT ≤ 1.5 times the upper limit of normal; Hemoglobin ≥ 9 g/dL; Platelets ≥ 100 x 10^9/L; Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L. Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol. Patient is a candidate for ANT DBS based on the following criteria established by the American Society for Stereotactic and Functional Neurosurgeons: Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, with or without generalization; Failure to adequately control seizures after two (or more) appropriate and adequately-dosed anti-seizure medications; Either partial-onset seizures with a localized onset in a region not amenable to resection or following failed resective surgery or focal-onset seizures with distributed or unclear onset zone.  Exclusion Criteria:  Patients who have undergone a prior intracranial procedure for epilepsy. Patients with an intracranial tumor. Confirmed pregnancy. History of cancer not in remission for at least 5 years. History of diabetes, chronic renal failure, or other significant underlying medical or ----immunosuppressive conditions. History of drug or alcohol abuse. Subjects allergic to any component of the investigational product. Subjects > 75 years of age. Cognitively impaired adults. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Ultra-high-caloric, Fatty Diet in ALS
Status: Not yet recruiting

This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria Disease duration (onset of first paresis or bulbar symptoms) < 24 months Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit) Age ≥18 years. Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion Capable of thoroughly understanding all information given full written informed consent according to good clinical practice  Exclusion Criteria:  Previous participation in another interventional study involving an active treatment within the preceding 4 weeks Tracheostomy or continuous permanent ventilator dependence (>22 hours per day) Pregnancy or breastfeeding Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma
Status: Recruiting

The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine.  Exclusion Criteria:  unwillingness to participate in the study severe media opacity - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study. - SamplingMethod: Non-Probability Sample
A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of HIV/AIDS Complicated With Infection
Status: Not yet recruiting

The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are:

Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression.
Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies.
Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sign the informed consent form. HIV positive. Any gender, age 18 to 70 years old  Exclusion Criteria:  1.Patients deemed unsuitable by the investigator to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: HIV/AIDS patients - SamplingMethod: Non-Probability Sample
BRING-UP 3 Heart Failure
Status: Recruiting

The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥18 years old. Males and females at birth. Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment). Ambulatory chronic HF or Hospitalized de-novo or worsening HF. Signed informed consent  Diagnosis will be made by the local attending physician following the ESC guidelines recommendations.  Exclusion Criteria:  Active neoplasia or very severe disease compromising short-medium term life expectancy. Participation in interventional studies. Patients already enrolled into the study from another participating center or in the previous enrolling phase. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients with chronic HF and those admitted for acute (de novo or worsening) HF. - SamplingMethod: Non-Probability Sample
Pupillometric Evaluation in Patients Declared Brain Dead - a Prospective Quality Control Study
Status: Recruiting

The aim of the study is to verify the reliability of the current purely clinical examination of the pupils (without the support of a pupillometer) in the context of clinically suspected brain death, compared to the results of a non-invasive, automated, and highly precise monocular pupillometric examination.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Suspected diagnosis of brain death Brain death diagnostic procedures planned Treated at the intensive care unit at the University Hospital Basel (USB) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patient population is defined as all adult patients (i.e. ≥18 years of age) treated on the intensive care unit at the University Hospital Basel (USB) in whom the treating physicians suspect brain death and plan to perform brain death diagnostic procedures. - SamplingMethod: Non-Probability Sample
Confidential Care and Adolescent HIV Testing
Status: Not yet recruiting

The purpose of this study is to assess the feasibility and acceptability of structural intervention components to increase adolescent HIV testing uptake by improving the implementation of confidential care as standard practice in pediatric primary care.

Eligibility:
- EligibilityCriteria: The intervention occurs at the clinic-level and so the enrolled participant is a pediatric primary care clinic. The patient-level outcome (i.e., change in HIV testing uptake) will be collected based on the following eligibility criteria:  Inclusion Criteria:  - 13-17 years old  Exclusion Criteria:  <13 years old >17 years old - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child
CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
Status: Not yet recruiting

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. Gender unlimited，18<Age; 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission 3. Estimated life expectancy of minimum of 12 weeks;  4. The blood routine meets the following standards:  Lymphocyte count>0.3×10e9/L; Neutrophils ≥0.5×10e9/L; Hemoglobin ≥60g/L; Platelet ≥30×10e9/L 5. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period; 6.Those who voluntarily participated in this trial and provided informed consent;  Exclusion Criteria:  1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown) 4. Patients with HIV infection 5. Active infection of hepatitis B virus or hepatitis C virus; 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 7. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L; 8. Any unsuitable to participate in this trial judged by the investigator; 9. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months; 10. Received immunosuppressive therapy within one week prior to mononuclear cell collection； 11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)； 12. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).
Status: Recruiting

Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Admitted to the hospital "Complejo Hospitalario de la GAI de Albacete" Meet the SARS-CoV-2 diagnostic criteria with positive PCR They have completed at least the first dose of Calcifediol within the first 72 hours after admission, (according to protocol).  Exclusion Criteria:  Patients who do not receive the full first doseof Calcifediol within the first 72 hours. Patients for whom electronic medical record data cannot be collected. Patients with other serious intercurrent diseases (eg advanced oncological pathology). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients admitted to the GAI Hospital Complex of Albacete, due to COVID-19 [respiratory infection confirmed by radiographic pattern of viral pneumonia and positive polymerase chain reaction (PCR)/antigen for SARS-CoV-2]. Those participants for whom there is not enough information in the files to be able to analyze the study hypotheses will be excluded from the study.  Patients meeting ALL inclusion criteria and NO exclusion criteria will be included in the study. - SamplingMethod: Non-Probability Sample