Kornimate/medical-research-clean huggingface dataset:
a study of bispecific antibody qls31901 in patients with advanced or metastatic malignancies

Conditions: Advanced Malignant Tumor

Summary: this is a phase 1, open label, non-randomised, dose-escalation single agent study with expansion cohorts for dose confirmation/safety and preliminary efficacy of qls31901 in advanced or metastatic malignancies

study design: this open label, multicenter, first in human study consists of 2 parts. part 1 is a dose escalation to find the recommended dose for the expansion. part 2 is a dose expansion to confirm the dose of qls31901 through further evaluation of safety, tolerability, pk, preliminary antitumor activity, and functional target engagement. the study includes three periods: screening( up to 28 days prior to the first dose of study drug); treatment(first dose of study drug with treatment cycles of 28 days); and follow-up ( 30days 、60days and 90 days after the last dose) including survival follow-up checks every 3 months up to 12 months after the death of patient or the end of this clinical trial .

Eligibility criteria:
inclusion criteria: 1. age: 18 to 75 years, male or female. 2. eastern cooperative oncology group (ecog) score of 0-1. 3. life expectancy ≥ 12 weeks. 4. at least one measurable lesion by imaging according to recist v1.1 evaluation criteria 5. patients who failed standard treatment or were absent of standard treatment and have a pathologically confirmed advanced malignant tumor. 6. sufficient organ function before the first dose of the investigational product exclusion criteria: 1. prior anti-cancer immunotherapy(those who have received pd1 / pdl1 can be included in this study). 2. known allergy to the investigational product or any excipient or severe anaphylaxis to other monoclonal antibodies. 3. received any of the following treatments or drugs prior to the first dose of the study: 4. symptomatic cns metastasis, leptomeningeal metastases, or spinal cord compression due to metastasis before signing of the informed consent form. 5. patients with uncontrollable severe exudation (thoracic cavity, pericardium, abdominal cavity); 6. presence of active autoimmune disease or has a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \[patients whose condition can be controlled by thyroid hormone replacement therapy can be enrolled\]; subjects suffer from skin diseases that does not require systemic treatment, such as vitiligo, psoriasis, alopecia, type i diabetes, or childhood asthma that has completely alleviated and does not require any adult intervention can be enrolled. asthmatic patients requiring bronchodilators for medical intervention cannot be enrolled);
predicting osteoarthritis risk following knee injury.

Conditions: Osteoarthritis; Injury

Summary: this observational study seeks to identify and validate novel soluble biomarkers (within blood, synovial fluid, urine) which contribute to the prognostic assessment of an individual with an acute knee injury, a group of individuals in which \~50% will progress to symptomatic radiographic knee osteoarthritis (oa). 150 individuals will be followed over 5 years with clinical assessment including validated questionnaires, biological sampling and radiological imaging (x ray, magnetic resonance imaging (mri)).


Eligibility criteria:
inclusion criteria: * clinically significant acute knee injury within 8 weeks of recruitment * aged 16-50 * knee effusion, evident clinically or by mri * evidence on mri of structural injury (from list of relevant injuries) * informed written consent exclusion criteria: * knee injured more than 8 weeks prior to recruitment * pre-existing advanced radiographic oa (kellgren lawrence (kl) grade 3-4) of same side knee at baseline * known history of inflammatory/septic arthritis of same side knee * knee replacement - previous or planned within 2 years of study start * active other (treated) inflammatory disease or infection * positive pregnancy test * not consenting, or contraindication to provide blood samples: * bilateral mastectomy * bilateral fistulae for renal dialysis * unable to give informed written consent in english

Keywords: biomarker inflammation prognosis knee
effectiveness of laboral kinesiotherapy in prevention of upper limb musculoskeletal disorders

Conditions: Upper Limb; Injury, Superficial, Multiple

Summary: abstract work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. objectives: the objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. methods: after a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (gcl) or to the "control group" (cg), considering 10% sample size lost and intention to treat. the primary outcomes will be the pain perceived by the numerical pain scale (ndt) and nordic questionnaire, and isokinetic muscle strength through the mean peak torque work of shoulder abduction. the discomfort and disability will be evaluated by the psfs and quickdash questionnaires. the ergonomic analysis of work will be evaluated by the manual "ergonomic analysis focused on activities" - eafa and application of qec, rula, reba and harm tools. statistical analysis will be performed through pasw statistics ™, version 20.0. the independent sample t test will be used to compare the groups. the cohen index will be set for the effect size calculation. all analyzes will be conducted with 95% confidence interval and p \<0.05 significance.


Eligibility criteria:
inclusion criteria: * workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities. exclusion criteria: * workers presenting: * pregnancy; * congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria); * severe cervical spine disorders, postoperative conditions in the neck or upper limb region; * uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise; * workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises. * workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.

Keywords: physiotherapy prevention pain upper limb exercises musculoskeletal disorders
women's treatment for trauma and substance use disorders - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to compare the effectiveness of adding seeking safety to standard substance abuse treatment to adding a control condition: women's health education to standard substance abuse treatment.


Eligibility criteria:
inclusion criteria - women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold dsm-iv ptsd. exclusion criteria: - women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold dsm-iv ptsd; and women who have current psychotic disorders, or a history of active psychosis (past two months).

Keywords: behavioral intervention
an observational study to collect data on how aflibercept (eylea) given using a paediatric dosing device is used in preterm babies with retinopathy of prematurity in the united kingdom (uk)

Conditions: Retinopathy of Prematurity; Preterm Infants

Summary: this is an observational study in which only data from babies with retinopathy of prematurity (rop) who are being treated with aflibercept (eylea) in prefilled syringe (pfs) using a paediatric dosing device (pdd) are collected and studied. rop is a condition that affects the eyes of preterm babies. it occurs when the baby's retina, the part of the eye that senses light, does not develop normally. this may result in vision problems, including blindness, if left untreated. preterm babies are born before 37 weeks of pregnancy. rop is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. aflibercept is a drug that is injected into the eye. it works by blocking a protein called vascular endothelial growth factor (vegf) which causes abnormal growth of blood vessels in the retina. aflibercept in pfs given using a pdd is approved for the treatment of babies with rop. the prefilled syringe will be fitted with an injection needle to give aflibercept. and a pdd is a tool used to give the right amount of aflibercept to children in a safe manner. since there are other treatments which are commonly used for babies with rop, the extent of use of aflibercept given using a pdd is unknown. the main purpose of this study is to: * find the number of preterm babies who are treated with aflibercept using a pdd in the uk * inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a pdd in babies with rop an additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of rop observed in babies being treated with aflibercept using a pdd. the data will come from a database called the national neonatal research database. the study will cover the period from march 2024 to march 2025, if the number of babies found is enough to perform the safety study. if not, data will be collected till april 2027. in this study only available data from preterm babies born during the study period are collected. no visits or tests are required as part of this study.


Eligibility criteria:
inclusion criteria: * eligible infants within the nnrd include those who were: * 1. born during the study period, i.e. from q4/2023 following market introduction of eylea pfs+pdd and 31st december 2026, and * 2. received care in a neonatal unit that contributes data to the nnrd and the unit has agreed to participate in the study, and * 3. diagnosed with rop in any stage in at least one eye. exclusion criteria: * infants with missing data for gestational age at birth will be excluded.

Keywords: rop
effect of reducing phosphorus absorption on cardiac biomarkers in hemodialysis patients

Conditions: End Stage Renal Failure

Summary: hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(esrd),however the majority of whom are in the absence of acute coronary syndrome(acs). and it is still unclear why cardiac biomarkers would increase in those patients. we hypothesized that excessive phosphorus is account for that phenomenon.to confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in hemodialysis patients for some time and observed the change of cardiac biomarkers of those patients.

cardiovascular disease is one of the leading causes of morbidity and mortality in patient with chronic kidney disease(ckd), accounting for more than 50% of all deaths.when myocardial cells get injured, cardiac biomarkers will be released into the circulation. elevated cardiac biomarkers have been observed in patients with various degrees of renal failure. however, the majority of those ckd patients are in the absence of acute coronary syndrome. so far, it is still unclear the mechanisms of the increased biomarkers in ckd patients. meanwhile, hyperphosphatemia is one of the major features of ckd, particularly of end stage renal disease(esrd). lots of evidences have shown that high levels of serum phosphorus and an elevation of the serum calcium × phosphorus product can lead to cardiovascular calcifications and subsequent cardiovascular morbidity and mortality in patients with ckd.it is tempting to hypothesize that hyperphosphatemia may be responsible for the rise of cardiac biomarkers in ckd patients.so we use one phosphate binder to reduce phosphorus absorption in hemodialysis patients for one year and observe the change of cardiac biomarkers of those patients.

Eligibility criteria:
inclusion criteria: * time of receiving hemodialysis is more than 1 year; * hyperphosphatemia before hemodialysis; * never use any phosphorus binder in the past 6 months. exclusion criteria: * receiving coronary artery stent implantation before; * having any cardiovascular disease in the past 6 months; * cannot tolerate the side effects of phosphorus binder; * dose not take medicine according to the prescription; * inadequate dialysis.

Keywords: phosphorus hemodialysis cardiac biomarkers
granulomatous pneumocystis pneumonia

Conditions: Pulmonary Nodule; Invasive Fungal Infections; Pneumocystis Jirovecii

Summary: the intra-alveolar form of pneumocystis jiroveci pneumonia (pjp) is a common pathology in immunocompromised patients, particularly those infected with hiv. the diagnosis is based on the detection of pj in a lba. intra-tissue granulomatous form (pgp) is a rare entity observed in non-hiv immunocompromised patients. in this case, the lba is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. for many years, it has been clearly demonstrated that the use of a specific pcr clearly improves the biological diagnosis of pcp. however, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned. in 2018, two cases of pgp were diagnosed at 3-month intervals at montpellier university hospital center. the diagnostic confirmation was obtained with pcr pj. in this context the investigators will investigate the interest of implementing pcr pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. in all selected patients, histopathological aspect of the nodule was compatible with a pgp and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). finally, 17 patients were selected to check retrospectively, if the presence of pj could be at the origin of the pathology.


Eligibility criteria:
inclusion criteria: * pulmonary nodule exclusion criteria: * nodule : tumoral, other infections than pj, inflammatory

Keywords: granulomatous pneumocystis pneumonia pcr pneumocystis jirovecii
bone modeling effects of combined anabolic/antiresorptive administration

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.


Eligibility criteria:
inclusion criteria: * women aged 45+ * postmenopausal * osteoporotic with high risk of fracture exclusion criteria: * significant previous use of bone health modifying treatments * known congenital or acquired bone disease other than osteoporosis * significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease * abnormal calcium or parathyroid hormone level * serum vitamin d \ 60ng/ml * serum alkaline phosphatase above upper normal limit with no explanation * anemia (hematocrit \<32%) * history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis * history of urolithiasis within the last one year * excessive alcohol use or substance abuse * use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months * extensive dental work involving extraction or dental implant within the past or upcoming 2 months * known sensitivity to mammalian cell-derived drug products * known contraindications to denosumab, teriparatide, or any of their excipients * known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class * continuous use of tetracycline for \>1-month duration within the last 10 years

Keywords: osteoporosis histomorphometry bone density teriparatide denosumab
safety and efficacy study of recombinant human lactoferrin to treat severe sepsis

Conditions: Severe Sepsis

Summary: study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * onset of severe sepsis within the previous 24 hours * must be receiving antibiotic therapy * informed consent form signed by patient, legal next-of-kin or legal guardian * able to take medication by mouth or feeding tube exclusion criteria: * receipt of investigational medication within 4 weeks prior to participation in the study * pregnant or breast-feeding * severe congestive heart failure * known severe hiv infection * presence of severe burns * patients on high dose immunosuppressants * patients whose death is considered imminent * patients whose life expectancy for concurrent illness is less than 6 months * severe hypoxic encephalopathy or persistent vegetative state * severe liver disease * patient, legal representative or patient's primary physician not committed to providing full, aggressive life support

Keywords: sepsis talactoferrin lactoferrin recombinant human lactoferrin
retrieve: reverse transcriptase inhibitor hiv practice

Conditions: HIV Positive

Summary: an observational retrospective study of nnrti experienced patients who have virologically failed. the study aims to assess resistance profiling and subsequent prescription patterns of patients on nnrtis

this is a cross-sectional study involving retrospective review of hiv-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (nnrti) and subsequently failed. patients who have virologically failed previous nnrti treatment, or have resistance to 1 drug in the nnrti class are examined further. such patients will have attended the clinic every 3-6 months for routine medical care. the data source for variables collected is the patient's electronic medical records. this database is located at holdsworth house medical practice (hhmp), sydney.

Eligibility criteria:
inclusion criteria: 1. documented hiv infection 2. attended holdsworth house medical practice 1999-2009. 3. chosen art regime includes an nnrti exclusion criteria: n/a

Keywords: antiretroviral therapy experienced failed nnrti regime
the effects of the myofascial trigger point injections on pain and sleep disturbance in patients with nocturnal leg cramps with trigger points on gastrocnemius muscle

Conditions: Nocturnal Leg Cramps

Summary: nocturnal leg cramps is involuntary strong contraction of leg muscle, mostly in calves. it occurs suddenly and induces pain. patients with frequent nocturnal leg cramps suffer from sleep disturbance in company with pain. in the present study, we examined the effects of the myofascial trigger point injections, which are known to be helpful for ease of nocturnal leg cramps, on pain and sleep disturbance in patients with nocturnal leg cramps with trigger points on gastrocnemius muscle.


Eligibility criteria:
inclusion criteria: * adult patients (20-80 years of age) scheduled for myofascial trigger point injections on gastrocnemius muscle due to nocturnal leg cramps at least once a week exclusion criteria: * patients with no trigger points on gastrocnemius muscle, * electrolyte abnormality, * congenital musculoskeletal disorder, * local or systemic infection, bleeding disorder or the use of anticoagulation medications, * known allergy of local anesthetics, or the use of hypnotics or sedatives in the last 1 month

Keywords: muscle cramps, trigger points, sleep disturbance
the effect of mandala on anxiety, physiological parameters and patient satisfaction in women with breast cancer

Conditions: Breast Cancer

Summary: this study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

breast cancer is among the most common cancers that cause death in women in the world and in our country (1). one of the most commonly used treatment options for breast cancer is chemotherapy. however, many side effects occur depending on the chemotherapy regimen used. the most common side effects in patients receiving chemotherapy are; nausea, vomiting, anemia, fatigue, insomnia, mucositis, and peripheral neuropathy (2, 3). it is stated that the probability of anxiety in people with cancer is 50% or more, while the rate of chronic anxiety is 30%. it is expected that the quality of life will be positively affected by detecting and reducing the level of anxiety and adapting patients to their own treatment (4). mandala, a type of art therapy method; although it has various shapes, the round one is generally preferred and is a meditation tool used to convey feelings and thoughts. studies have shown that art therapy helps individuals feel more peaceful by helping to alleviate strong negative emotions that cause severe discomfort (7). in a study conducted in hong kong, the sample group included women with both breast cancer and gynecological cancer. art therapy was applied to the participants, and as a result of the research, it was observed that the women's psychological distress decreased and their mental well-being increased (8). it is known that the problems experienced by cancer patients can be reduced by changing cognitive focus, similar to art therapy. in a study, cancer patients receiving chemotherapy watched tv series and movies (51.3%), dreamed (26.6%), listened to music (26.6%), visited friends and relatives (19.6%), looked at flowers (14%), walked or walked. it is observed that their depression and anxiety decrease when they engage in activities such as exercising (14%) (9).in the literature, there are mandala studies applied to different patient groups, but no national or international study has been found regarding the effects of mandala painting during chemotherapy in breast cancer patients. therefore, this study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

Eligibility criteria:
inclusion criteria: * being diagnosed with breast cancer, * being receiving adjuvant or neoadjuvant chemotherapy, * being over 18 years of age, * ability to communicate in turkish, * not having a physical disability related to the upper extremities, * agreeing to participate in the study. exclusion criteria: * advanced stage cancer patients, * having visual, hearing and speech disabilities, * individuals with mental and neuropsychiatric diseases will not be included in the sample.

Keywords: breast cancer nursing mandala