Kornimate/medical-research-clean huggingface dataset:
a phase ii trial of ak104 in advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer

Summary: phase ii open label, multicenter study to evaluate the efficacy and safety of ak104 (anti-pd-1 and ctla-4 bispecific antibody) combined with docetaxel in advanced non-small cell lung cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-pd-1/pd-l1 monoclonal antibody


Eligibility criteria:
inclusion criteria: 1. 18 to 75 years old. 2. have a life expectancy of at least 3 months. 3. have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. has a histologically or cytologically confirmed diagnosis of locally advanced or metastatic nsclc. 5. has radiographic progression after prior platinum doublet chemotherapy and anti-pd-1/pd-l1 monoclonal antibody (mab) administered. 6. no known epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) mutations. 7. has at least 1 measurable lesion per recist 1.1 assessed by investigator. 8. has adequate organ function. exclusion criteria: 1. undergone major surgery within 30 days prior to the first dose of study treatment. 2. active central nervous system (cns) metastases. 3. history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. active hepatitis b or hepatitis c. 5. received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. has received treatment with docetaxel. 7. history of severe bleeding tendency or coagulation disorder.
exercise and prp vs exercise alone in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (prp) injection versus only exercise or only prp treatments.


Eligibility criteria:
inclusion criteria: * adults 40-70 years of age, * grade 2-3 according to kellgren lawrence osteoarthritis classification, * no medication for knee osteoarthritis in the past three months, * subjects who understand and sign the consent form for this study. exclusion criteria: * patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months, * previous partial or total knee replacement of the target knee, * body mass index \> 30 kg/m2, * having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases, * impaired cognition that impacts the ability to give informed consent, * participation in another clinical trial.
efficacy and safety of chondron (autologus chondrocyte) in patients with cartilage defects in their ankle

Conditions: Defect of Articular Cartilage; Degenerative Joint Disease of Ankle and/or Foot; Ankle (Ligaments); Instability, Familial

Summary: the objective of this study is to evaluate the efficacy and safety of chondron (autologus chondrocyte) in patients with cartilage defects in their ankle for 18 months

this is an open label trial, involving a total of 28 subjects. subjects who give consent will be screened and those who meet trial criteria will receive chondron (autologous cultured chondrocyte) by transplant. during the trial period, subjects must follow the instructions given by principal investigator. subjects will make 6\* hospital visits on a regular basis inclusive of hospitalization. during these visits subjects will be examined. for the evaluation of safety and efficacy of chondron, examination with doctors, x-ray, mri tests and arthroscopy will be performed. \*if tissue samples can be collected at screening visit, there will be only 5 visits.

Eligibility criteria:
inclusion criteria: * 1. adult men and women over 15 and less than 65 years of age 2. applicable to patients who have a partial cartilage defect in their ankle based on an mri (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 3. patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance 4. patients which surrounding cartilage are normal 5.patients with a grade iii or iv cartilage defect size on the icrs (international cartilage repair society) 6. patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form exclusion criteria: * 1. patients hypersensitive to bovine protein 2. patients hypersensitive to gentamicin antibiotics 3. patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis 4. patients with arthritis related to autoimmune disease 5. pregnant, breast-feeding patients or those who have a possibility of pregnancy 6. patients with accompanying diseases other than articular cartilage defects, including tumors 7. patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years 8. patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that chondron administration is possible is appended by a doctor are excluded) 9. patients who are administering antibiotics and antimicrobial agents due to infection 10. patients who receive steroid hormone therapy 11. patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Keywords: a partial cartilage defect of ankle chondron autologus chondrocyte
low-magnitude high-frequency vibration study on fracture rate in community elderly

Conditions: Fractures

Summary: fragility fracture is common due to global aging problem, incurring huge healthcare expenditure. the occurrence of fragility fracture is usually caused by a fall incidence of an elderly with low bone quality and poor balancing ability. therefore, any approach to improve or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture incidence. with the intensive research on low magnitude high frequency vibration (lmhfv), many scientific evidences support the application of this biophysical modality on elderly to maintain or improve the musculoskeletal tissues in elderly. many previous studies showed the osteogenic properties of vibration treatment and its positive effects on muscular performance and blood circulation. the investigators' previous reports also indicated that lmhfv could enhance the bone quality in spine and tibia in elderly after one-year intervention, as well as the balancing ability with high compliance. in animal studies, the application of lmhfv on fracture healing also demonstrated the significant acceleration of healing by inducing callus formation and maturation, from which upregulation of collagen i, ii and bmp-2 gene expression was detected at molecular level. to date, the long-term efficacy of lmhfv on reducing fracture risks and fracture rate is, however, not available, which needs a systematic large-scale study to answer this important research question. therefore, the hypothesis of this study is that lmhfv can maintain or enhance the performance of various tissues of the musculoskeletal system in community elderly, thus reducing the fracture risks and fracture rate. a large-scale prospective randomized clinical trial will be conducted in multiple communities to investigate the long-term effect of lmhfv on fracture rate and reduction of fracture risks in community elderly, in which multi-factorial effects, in terms of muscle and bone, on musculoskeletal system will also be evaluated. a total of 704 elderly from 28 community centres will be recruited within 1.5-year time for a 18-month lmhfv treatment, who will be assessed on the fracture risks at fixed time points while their fracture rates on the third year of this study will be regarded as primary outcome for analysis. the findings of this study will provide very useful scientific data to support the application of lmhfv for elderly. the ultimate goal is to reduce the fracture rate and the quality of life of community-living elderly.


Eligibility criteria:
inclusion criteria: * 65 years old or above * independent in accessing the centres exclusion criteria: * having habitual exercise or participate in supervised exercise * having drug treatment that affects normal metabolism of musculoskeletal system * having hypo- or hyperparathyroidism, renal, liver or other chronic diseases * having low-energy fracture history * previous or current smokers or drinkers

Keywords: fracture rate fracture risks
retrospective analysis of outcomes with a pharmacogenomic algorithm

Conditions: Depression; Anxiety

Summary: antidepressants are among the most widely prescribed medications, yet only 35-45% of patients achieve remission following an initial antidepressant trial. the financial burden of treatment failures in direct treatment costs, disability, decreased productivity, and missed work may in part derive from a mismatch between optimal, and actual, medications prescribed. the present one year retrospective study seeks to evaluate the indirect and direct healthcare costs for 96 patients with a dsm-iv-tr depressive or anxiety disorder, in relation to an interpretive reporting system designed to predict antidepressant responses based on dna variations in cytochrome p450 genes (cyp2d6, cyp2c19, cyp1a2), the serotonin transporter gene (slc6a4), and the serotonin 2a receptor (5htr2a) genes.


Eligibility criteria:
inclusion criteria: * major depressive disorder * dysthymic disorder * depressive disorder nos * obsessive compulsive disorder (ocd) * generalized anxiety disorder * panic disorder * anxiety disorder nos * post-traumatic stress disorder (ptsd) * social phobia exclusion criteria: * bipolar disorder * schizophrenia * schizoaffective disorder * previous pharmacogenomic testing
building of a diagnostic/prognostic database for human erg variant effects

Conditions: Long QT Syndrome

Summary: cardiac channelopathies induce severe heart rhythm or conduction disorders. mutations of the kcnh2 gene, that encodes the human (h) erg channel, is responsible for 30-40% of all cases of long qt syndrome (inherited lqt2). besides, herg is frequently responsible for off-target effects of several pharmacological agents (acquired lqt2). with the advent of next generation sequencing, hundreds of new kcnh2 variants are accumulating in regional databases including those developed by french centers of references. worldwide, we estimate there are more than 1000 variants for herg channel. unfortunately, many of these new variants appear to be of unknown functional significance in spite of available clinical and genetic information. little is known on whether they affect the channel biophysical properties, its expression at the cell surface and/or its structure. yet, this information is crucial to determine the real degree of pathogenicity of these variants, and therefore to make the proper diagnosis on inherited lqt2, counsel the patient for his treatment and improve the management of the patient's life. our ambition is therefore to tackle this issue of variant significance by (i) launching a large-scale multi-functional evaluation of herg variants, (ii) introducing for the first time a formatted large-scale pathogenicity annotation score for all variants that have been functionally evaluated by this multi-parametric approach, and (iii) regrouping all the relevant information collected in every french regional centers of reference into a single national database hosted by an infrastructure that possesses enough flexibility for continuous data implementation and cross-referencing. the database will integrate the latest international guidelines for functional pathogenicity annotation. this project will also include the pharmacological characterization of several drugs susceptible to produce acquired lqt2 with variable severities. we aim to understand whether there are structural regions within herg channel in which the introduction of a variant is more prone to increase the risk of acquired lqt2 or if, on the contrary, a set of variants may relatively protect some patients against lqt2-inducing drugs.


Eligibility criteria:
inclusion criteria: * patients carrier of a mutation in kcnh2 gene exclusion criteria: * patients who refuse to take part to research

Keywords: long qt syndrome kcnh2 gene variants
the difference between non-invasive high-frequency oscillatory ventilation and non-invasive continuous airway pressure ventilation in covid-19 with acute hypoxemia

Conditions: COVID-19 Pneumonia; Non-invasive Ventilation

Summary: high frequency oscillatory ventilation (hfov), as an ideal lung protection ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ards) after failure of conventional mechanical ventilation. although its ability to improve oxygenation and enhance carbon dioxide (co2) clearance has been repeatedly demonstrated in laboratory studies, its impact on the clinical results of these patients is still uncertain. noninvasive high-frequency oscillatory ventilation (nhfov) combines the advantages of hfov and non-invasive ventilation, and has become the current research focus in this field. it is recommended to use it after the failure of routine non-invasive ventilation treatment to avoid intubation. for the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. the gradual increase of clinical application of nhfov has also enriched its application in the treatment of other diseases. at present, non-invasive high-frequency oscillatory ventilation has not been applied to the study of adult covid-19 with acute hypoxemia, which will be the first study in this field.


Eligibility criteria:
inclusion criteria: 1. after covid-19 nucleic acid detection, imaging confirmed covid-19; 2. age ≥ 18 years old; 3. at the time of admission, the blood gas was acute hypoxic respiratory failure, the fraction of inhaled oxygen concentration (fio2) was at least 0.40, but the blood oxygen saturation (spo2) was 94% or lower; 4. be able to follow the instructions of the researcher. exclusion criteria: 1. critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; multiple organ failure (\>2 organs); 2. hemodynamic instability; 3. after extubation of invasive mechanical ventilation; 4. patients who cannot wear a mask, such as maxillofacial or upper airway surgery; 5. patients who may affect the treatment effect of nppv, such as nasal obstruction or upper respiratory tract obstruction; 6. obvious bullae, pneumothorax and pleural effusion; 7. it is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer; 8. those who refuse to participate in this test.

Keywords: noninvasive high frequency oscillatory ventilation covid-19 pneumonia acute hypoxic respiratory failure
safety and efficacy of long-term treatment with sct800 in previously treated hemophilia a patients.

Conditions: Hemophilia A

Summary: this study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of sct800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia a who have been previously treated with coagulation factor viii(fviii) . this study includes two phases: the screening period and prophylaxis period.prophylaxis with 25 - 50 iu/kg of sct800 shall be administered once every other day or three times per week starting from v1, on-demand treatment is given when bleeding episodes occur. the study period is 120 consecutive weeks.


Eligibility criteria:
inclusion criteria: * male patients who are diagnosed with severe (laboratory tested fviii:c \<2%) hemophilia a; * patients who completed trial of sct800-a302 or sct800-a 303 and new ptp(previously treated patients)(previously received fviii prophylactic or bleeding treatment, have the relevant records and are verified to have accumulated exposures days( eds) ≥150 days; * negative fviii inhibitor assay results (laboratory tested nijmegen-bethesda assay result \<0.6 bu(bethesda unit)/ml); * the treatment records of at least 50eds before screening can be obtained; * hiv negative; if hiv positive, the viral load \ 200/μl; * the patient or his guardian voluntarily signed the informed consent form. exclusion criteria: * known allergy to any coagulation factor viii or any excipient; known allergy to bovine, rodent or hamster bovine; * has a history or family history of blood coagulation factor viii inhibitor; * patients with other coagulation dysfunction diseases in addition to hemophilia a; * patients with other clinically significant diseases, alcoholism, drug abuse, mental disorders or intellectual disabilities; * patients with other severe or clinical significant diseases verified by the investigator to be unable to benefit from the clinical study; * patients who participated in other clinical studies within one month before the first drug administration (except fviii trials) and patients who participated in other fviii clinical trials after signing the informed consent form;
over-the-counter antihistamines & heat stress

Conditions: Heat Illness; Allergic Rhinitis; Heat Injury; Sudomotor Sympathetic Dysfunction

Summary: allergic rhinitis (ar) currently affects \~25% of canadians, and due to factors of climate change, this number is expected to increase over the coming decade. ar symptoms can significantly impact individuals' quality of life by compromising sleep, productivity, and social interactions. to alleviate ar symptoms, north americans tend to rely on h1 antihistamine medications available over-the-counter (otc) at most pharmacies. however, public health authorities currently suggest restraining all antihistamines during heat waves due to beliefs that m3 muscarinic receptor and h1 receptor antagonism, independent pharmacological mechanisms of h1 antihistamines, might suppress thermoregulatory responses to heat stress and increase individuals' susceptibility to heat-related illness/injury. to date, studies using supramaximal doses of antihistamines have demonstrated reductions in sweating, however these doses and administration routes are not the typical use case. additional studies utilizing fexofenadine, a second-generation h1 antihistamine, have linked h1 receptor antagonism to reductions in skin blood flow, potentially impacting thermoregulation by reducing peripheral blood redistribution. empirical evidence supporting otc h1 antihistamines impacting thermoregulatory control at recommended doses is scarce. thus, this study aims to systematically assess whether three common otc h1 antihistamines, taken as prescribed, alter thermoregulatory responses during thermal stress.


Eligibility criteria:
inclusion criteria: * male or female between ages 19 and 39 years * fully vaccinated against covid-19 * able to provide informed consent * body-mass index under 30 exclusion criteria: * body-mass index over 30 * currently taking sedative or autonomic nervous system depressant medication * hypersensitivity to diphenhydramine, loratadine, or desloratadine * history of cardiovascular disease, cancer, type 1 or 2 diabetes, chronic obstructive pulmonary disorder, or cystic fibrosis * have smoked tobacco products less than 12 months prior to participation * pregnant/breastfeeding

Keywords: h1 antihistamine sweating heat stress thermoregulation m3 muscarinic receptors h1 receptor antagonism m3 muscarinic receptor blockade heat illness/injury allergic rhinitis over-the-counter antihistamines allergy medication
efficacy and safety of fermented velvet antler extract on fatigue recovery after exercise

Conditions: Chronic Fatigue Syndrome

Summary: the investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented velvet antler extract on fatigue recovery after exercise. the investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and ldh, and monitored their blood pressure.


Eligibility criteria:
inclusion criteria: * males and females 19-60 years old * hemoglobin concentration between 13 and 14 g/dl(men), 12 and 13 g/dl(women) * able to give informed consent exclusion criteria: * allergic or hypersensitive to any of the ingredients in the test products * history of reaction to any of the test products or of gastrointestinal diseases such as crohn's disease or gastrointestinal surgery * participation in any other clinical trials within past 2 months * laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * pregnant or lactating women etc.
amyloidosis incidence in high-risk cardiac device patients

Conditions: Amyloid; Cardiac Amyloidosis; Amyloidosis Cardiac; Systemic Amyloidosis; AL Amyloidosis; Infiltrative Cardiomyopathy, Amyloid; ATTR Amyloidosis Wild Type

Summary: this single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. by analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. the study, running from december 2023 to december 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

the study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, icds, and crt-d/ps. standard surgical procedures are adhered to, ensuring minimal additional risk to patients. the collected tissue samples are analyzed by the hca pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. in addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. strict measures are in place to protect patient confidentiality and data security. by potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.

Eligibility criteria:
inclusion criteria: * patients who are 40 years of age or older * patients who are able and willing to provide informed consent * patients who are scheduled for cied implantation within the study period and with clinical lab and imaging features suggestive of cardiac amyloidosis exclusion criteria: * individuals below the age of 40. * persons who are unable to consent or who do not consent to participate. * patients who have already been diagnosed with cardiac amyloidosis prior to the study

Keywords: cardiac devices chest wall fat pad biopsy cardiac implantable electronic devices
short duration electrical stimulation to improve outcomes after cubital tunnel release (select) trial

Conditions: Neuropathy;Peripheral

Summary: a novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.


Eligibility criteria:
inclusion criteria: * ulnar neuropathy at the elbow exclusion criteria: * peripheral neuropathy outside of nerve of interest * patients with any active implanted device