Kornimate/medical-research-clean huggingface dataset:
a phase i/ii clinical trial of icp-723 in the treatment of advanced solid tumors

Conditions: Solid Tumors

Summary: a multicenter, nonrandomized, open-label phase i/iiclinical trial to evaluate the safety, tolerability, and pharmacokinetics of icp-723 in patients with solid tumors

solid tumors

Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (cns) tumors.. 2. age: adult cohort: age ≥ 18 years; adolescent cohort: 12 ≤ years \< 18 years. 3. at least one measurable lesion as per recist1.1 criteria, or for primary cns tumors, at least one measurable lesion as per rano or inrc criteria. 4. adult cohort: ecog ps score of 0-1; 5. adolescent cohort: karnofsky (age ≥ 16 years) or lansky (age \ 60. 6. life expectancy \> 3 months. 7. female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment. 8. patients who have signed the informed consent form voluntarily and agree to follow the therapeutic regimen and the visit schedule. exclusion criteria: 1. any other active malignancy within 5 years prior to the first dose of the study drug. 2. prior anti-cancer treatment within 28 days prior to the first dose. 3. major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug. 4. a history of allergic disease, severe drug allergy, known hypersensitivity to any component of the icp-723 tablet formulation. 5. other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study. note: other protocol defined inclusion/exclusion criteria may apply.
knee isometric program (kip) home exercise programs (hep) physical therapy (pt) study

Conditions: Anterior Knee Pain Syndrome

Summary: the purpose of this study is to evaluate the efficacy of a knee isometric program (kip) as compared to the current gold standard treatment for anterior knee pain (patellofemoral clinical practice guideline \[cpg\] - academy of orthopedic physical therapy).

participants will be randomly allocated into the kip or control intervention via spreadsheet randomization algorithm at the time of consenting. each patient will have equivalent experiences for the duration of the study regardless of allocation. time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. participants will be asked to refrain from any outside forms of lower extremity strengthening or training. usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. proper use of the pain journal will be explained during consent and again at the initial intake session.

Eligibility criteria:
inclusion criteria: * accept all provisions of the study and agree to complete the program in its entirety * age between 18-65 * complaint of anterior knee pain for at least 4 weeks, but no more than 12 months * prescribed referral for physical therapy for their knee(s) from one of the investigators exclusion criteria: * potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation * any neurological or degenerative musculoskeletal condition involving the lower extremities * ages outside of 18-65 * surgical history or fracture within the last 12 months on the affected extremity(ies) * currently participating in a structured strength training program * inability to access clinic for data collection or follow-up sessions * significant anatomical anomaly or limb alignment disorder as diagnosed by medical professional (femoral anteversion/retroversion, patella alta/baja, varus/valgus deformities, patella deformities/fractures, osteotomy procedures, limb lengthening procedures) * significant cartilage damage as diagnosed by medical professional (grade 3+ chondral defects of the femur or patella) * any other condition that limits full weight bearing of the affected lower extremity(ies) * vulnerable populations
changes in specific immunoglobulin and blood basophil activity during subcutaneous immunotherapy in allergic rhinitis

Conditions: Allergic Rhinoconjunctivitis

Summary: the trial is randomized prospective study to examine the effects of subcutaneous immunotherapy on the adaptive immune system. the trial includes 30 participants randomized to treatment or control group. the effect measures are changes in the basophil activity and biology as well as changes in plasma cells during and after treatment. clinical outcome is assessed by qol questionnaires and clinical testing. hypotheses: * changes in plasma cells correlate to changes in immunoglobulins and effector cell responses * the reduction of inflammation due to scit has influence on the effector cell responses * changes in paraclinical measurements can be related to clinical findings

the investigators are recruiting 30 participants, which are randomized to receive scit (24) or no treatment (6) the following will be measured * the development of immunoglobulin response * plasma cells under updosing phase * changes in basophil activity under updosing and maintenance treatment * subtyping of allergic sensitization * clinical outcome and quality of life * changes in mast cells in the nasal mucosa * changes in the cell biology of the basophils

Eligibility criteria:
inclusion criteria: * rhinoconjunctivitis due to grass pollen allergy * positive skin prick test and nasal allergen challenge test to grass pollen extract exclusion criteria: * severe comorbidity, severe asthma, pregnancy

Keywords: basophil activity plasma cells ige igg1 igg4 mast cells ige receptor allergic rhinoconjunctivitis grass pollen allergy
18f-fdg pet-mri for planning and follow-up of patients with spine tumors treated with spine stereotactic radiosurgery

Conditions: Metastatic Malignant Neoplasm; Metastatic Malignant Neoplasm in the Bone

Summary: this trial studies how well 18f-fdg pet-mri works for treatment planning in patients with spine tumors. diagnostic procedures, such as 18f-fdg pet-mri may help radiation oncologists plan the best treatment for spine tumors, as well as help in follow-up after radiation therapy.

primary objectives: i. determine the therapeutic efficacy of fludeoxyglucose f-18 (18f-fdg) positron emission tomography (pet)-magnetic resonance imaging (mri) in spine stereotactic radiosurgery (ssrs) treatment planning compared to advanced mri (amri) and conventional mri (cmri). ii. determine the diagnostic accuracy of 18f-fdg pet-mri in follow-up of patients treated with ssrs. secondary objectives: i. analysis of the subset of patients who eventually suffer local treatment failure to determine patterns of failure and potential predictive pet/mri features at baseline. ii. analysis of the subset of patients who suffer complications of ssrs (e.g., vertebral compression fracture) to determine potential predictive imaging features. outline: patients receive fludeoxyglucose f-18 intravenously (iv) over 1 minute, and then undergo pet-mri over 1 hour, 30 days before radiation therapy, and 3 and 6 months after radiation therapy.

Eligibility criteria:
inclusion criteria: * consent to imaging study * presence of at least 1 lumbar vertebral body bone metastasis \> 1 cm in shortest diameter and smaller than 75% of the vertebral body cross sectional area. metastasis may be determined by pathology, or imaging appearance. * eligibility to receive ssrs (determined by treating radiation oncologists) * plan for single-fraction ssrs * standard-of-care spine mri within 8 weeks of radiation therapy * ability to understand and willingness to sign a written informed consent document * non-english speaking participants will be included. verbal translation preparative sheet (vtps) short form will be utilized in consenting non-english speaking participants. exclusion criteria: * absolute or relative contra-indication to mri, including presence of a pacemaker that requires involvement of cardiology/anesthesiology during the scan * prior directed radiation to the involved segment * contra-indication to gadolinium based contrast agents (e.g., allergy, pregnancy) * individuals younger than 18 years * hardware at the treatment level or hardware affecting visualization of the involved level on mri * pregnant women
effects of resistance training on substrate metabolism during the menstrual cycle

Conditions: Menstrual Cycle; Substrate Metabolism

Summary: this research project's objective is to investigate substrate metabolism behavior in response to the rt during different phases of the menstrual cycle.

based on the literature the investigators hypothesize an increase in fat oxidation in early follicular phase(efp) and late follicular phase (lfp) when compared to early luteal phase (elp) and late luteal phase (llp). given the lack of research in exercise and menstrual cycle - especially in resistance training - results are uncertain unless the investigators base their hypotheses only on the general physiological effects of sex hormones (without exercise). in this case, the investigators expect to see a reduced carbohydrate utilization and an increased utilization of fats in efp and lfp. in addition, the intervention is focused on muscular endurance and, therefore, it is expected to see a higher reliance on aerobic pathways. it is expected that the effects of the intervention will be added to the effects of estrogens, with increasing fat oxidation when estrogen levels are higher. lastly, a comparison of fat oxidation levels obtained on each sub-phase would reveal if there are differences in the magnitude of the effect of distinct concentrations of estrogen and progesterone.

Eligibility criteria:
inclusion criteria: * females with bmi-18.5-34.99 and between 18-45 years, with normal menstrual cycle defined as 28-30 days cycles +-3 days. * including higher bmi participants might alter the results as increased body fat has been linked to changes in different hormonal levels (not only sex hormones) and that might influence substrate utilization. * sedentary .or physically active for 2 days a week or less. exclusion criteria: * • musculoskeletal injuries, * cardio-respiratory conditions, * metabolic conditions, * irregular menstrual cycle, * menstrual dysfunction or unusual sex hormone levels, * on contraceptives, * on medication that alter hormonal or cardio-respiratory responses, * pre-menopausal symptoms, * on moderate to high-intensity exercise regime more than 2d/week. * all these exclusion criteria are chosen because any one of the listed criteria above can alter the responses and/or affect the safety of the subject during their participation in the study.

Keywords: resistance training carbohydrate metabolism fat oxidation
anemia studies in ckd: erythropoiesis via a novel phi daprodustat - pediatric (ascend-p)

Conditions: Anaemia

Summary: this is an international, multicenter trial, evaluating pharmacokinetics (pk) (4 weeks), safety (52 weeks), and hemoglobin (hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (ckd) incorporating 2 independent sub-trials (non dialysis \[nd\] and dialysis \[d\]). this study will enroll participants with anemia associated with ckd, in 2 distinct sub-populations differing only by their ckd stage and dialysis requirement (nd: ckd stage 3 to 5 not yet receiving dialysis and d: ckd stage 5d undergoing peritoneal dialysis \[pd\] or hemodialysis \[hd\]). the maximum duration of the study will be approximately 60 weeks, including screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). outcome measures are identical for the nd and d sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than \[\<\] 18 years, 6 to \<12 years, 2 to \<6 years, and 3 months to \<2 years). except for pk and dose change, which is within each age group only.


Eligibility criteria:
inclusion criteria: * participant must be 3 months to less than (\<)18 years of age. * anemia associated with ckd stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent ckd, defined as hgb 7.0 to 11.0 g/dl (if not using erythropoiesis stimulating agents \[esas\]) or hgb 9.5 to 12.0 g/dl if using esas. * written informed consent or assent as appropriate. exclusion criteria: * kidney transplant recipient with a functioning allograft. * scheduled for elective kidney transplantation within 3 months. * transferrin saturation (tsat) \< 20 percent (%), or ferritin \<25 nanogram (ng)/milliliter (ml). * history of bone marrow aplasia or pure red cell aplasia. * active hemolysis. * other causes of anemia. * active gastrointestinal bleeding within the last 4 weeks. * active or previous malignancy within the last 2 years. * acute or chronic infection requiring antimicrobial therapy. * history of significant thrombotic or thromboembolic events within the last 8 weeks. * heart failure (hf) new york heart association (nyha) class iv * uncontrolled hypertension. * alanine aminotransferase (alt) \>2× upper limit of normal (uln), bilirubin \>1.5× uln (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.

Keywords: daprodustat ascend-p anemia chronic kidney disease erythropoiesis stimulating agent dialysis non-dialysis 214066 212914
the study of the validation of general evaluation score (ges) in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis and cirrhosis who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs

Conditions: Hepatocellular Carcinoma

Summary: this cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (f3) and cirrhosis (f4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 years or older. * patients with compensated advanced chronic liver disease (cacld) according to baveno vi consensus (f3-f4) * achieved svr for hcv after daas. exclusion criteria: * previous interferon (ifn) treatment. * hepatitis b virus (hbv) or human immune-deficiency virus (hiv) co-infection. * current hepatocellular carcinoma (hcc) or other malignancies. * previous history of hcc or hcc intervention. * liver cell failure, liver transplantation or renal impairment
impact of idh mutation and adjuvant chemo(radio)therapy on survival outcome in grade ii/iii astrocytoma

Conditions: Astrocytoma; Astrocytic Tumors; Astrocytoma of Brain

Summary: this study looked at a type of brain tumor called astrocytoma and how specific genetic changes like idh mutations affect patients outcomes. recent studies found that people with idh-mutated astrocytomas tend to live longer and have better survival rates compared to those without these mutations. one reason for this is that idh-mutated tumors usually grow more slowly and are less aggressive. these findings suggest that testing for idh mutations could help doctors make more personalized treatment plans for patients, which may lead to better results. however, larger studies are needed to confirm these observations. the investigators used the surveillance, epidemiology and end results (seer) database to obtain the data of 811 patients with grade ii/iii astrocytoma. the data are publicly available and no consent or ethical approval is needed for this study. the clinicopathological data of patients, including the age, gender, race, idh status (mutant/wild), astrocytoma type (diffuse/anaplastic), surgery (tumor destruction, local excision, partial, radical, total gross resection, surgery), radiation (beam radiation, radioactive implants including brachytherapy, radioisotopes, combination of beam with implants or isotopes, radiation, method or source not specified), chemotherapy, vital status, and survival months, were extracted. patients were sub-grouped according to the idh type into idh mutant-type and wild-type. with further stratification according to the treatment modality into three groups: adjuvant chemotherapy, adjuvant radiotherapy, and combined adjuvant chemoradiotherapy. the observed survival and cause-specific survival were calculated using seer\*stat software version 8.4.3 and spss version 25 was used for survival analysis. significance was achieved at 0.05.


Eligibility criteria:
inclusion criteria: * patients were selected only if they had astrocytoma with malignant behavior * grade ii-iii astrocytoma * first primary tumor with sequence 0 or 1 * had surgical intervention (tumor destruction, local excision, partial, radical, total gross resection, surgery) exclusion criteria: * unknown survival time * patients with unknown age * death certificate only and autopsy only cases

Keywords: chemotherapy survival astrocytoma wild idh
spinal clearance study: expediting the spinal clearance process in the major trauma patient

Conditions: Multiple Trauma; Traumatic Brain Injury; Spinal Injuries

Summary: the alfred hospital receives approximately 40% of the major trauma patients in victoria, all of whom are at risk for spinal injuries. the potential for spinal injuries necessitates the undertaking of appropriate spinal investigations, and a delay in the completion of these investigations exposes the patient to the risk of a missed diagnosis of spinal instability and of complications of immobility; the potential spinal patient is required to wear a neck collar and be nursed lying flat whilst awaiting the completion and the appropriate documentation of spinal x-ray investigations. the purpose of this study is to identify the issues causing a delay in the process of the completion of the appropriate spinal investigations and the documentation of the results. the outcome of the proposed research will be the development of a clinical management protocol to expedite the process, with the aim of optimising patient care and reducing complications.


Eligibility criteria:
inclusion criteria: * major trauma patients exclusion criteria: * patients not subjected to spinal position restrictions on admission * patients deceased prior to spinal clearance * patients transferred to another centre prior to spinal clearance

Keywords: cervical spine injury multiple trauma
the effect of different macronutrients on gastrointestinal hormone secretion after gastric bypass operation

Conditions: Bariatric Surgery (Gastric Bypass); Overweight

Summary: the purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = glucagon-like peptide-1) in gastric bypass operated patients. the study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.


Eligibility criteria:
rygb patients: inclusion criteria: * underwent rygb surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month) exclusion criteria: * inadequate thyroid substitution, undergoing treatment with drugs known to interact with orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. type 1 or 2 diabetes mellitus now or prior to rygb operation. serious heart or respiratory illness. haemoglobin levels below 6,5 mm. healthy control subjects: inclusion criteria: * have not underwent bariatric surgery. exclusion criteria: * inadequate thyroid substitution, undergoing treatment with drugs known to interact with orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. type 1 or 2 diabetes mellitus now or prior. serious heart or respiratory illness. haemoglobin levels below 6,5 mm.

Keywords: glucagon-like peptide-1 glucose-dependent insulinotropic peptide glucagon peptide yy 3-36 ghrelin body weight obesity overnutrition overweight gastrointestinal agents glp-1 secretagogue
palliative and end-of-life care in advanced dementia: evaluation of a program of organization of care in long-term care

Conditions: Dementia

Summary: rationale: in canada, as in most industrialized countries, alzheimer's disease and other related dementia are increasingly prevalent in older people. at an advanced stage, institutionalization in a long-term care (ltc) setting will be the fate of a majority of patients. a structured palliative care approach is increasingly used for cancer patients, but is still rarely accessible in ltc institutions for older people with advanced or terminal dementia. this approach should include a more systematic detection and treatment of pain and other physical and psychological symptoms during the last weeks of life, as well as better communications between patients, families and care staff, particularly relating to advanced care directives. objectives: the general objective of this study is to implement and evaluate a multidisciplinary and multidimensional program of palliative and end-of-life care for older persons with terminal dementia in ltc facilities. methodology: the intervention program will include five components: 1. daily involvement of a nurse from the regular staff in the ltc facility as a change agent; 2. awareness sessions with administrators and staff on the importance of high quality palliative care in dementia; 3. a training program for physicians and all the staff involved in direct care of patients; 4. systematic discussions with families and distribution to families of a document on different aspects of palliative care in dementia; 5. systematic clinical care by regular staff for the control of pain, respiratory symptoms and mouth care. the program will be implemented in two ltc settings (one in quebec city and one in sherbrooke, quebec, canada), and results will be compared with the ltc control settings where usual care will be applied without implementation of the program.


Eligibility criteria:
inclusion criteria: residents with advanced dementia with a score of 7 on the reisberg scale

Keywords: advanced dementia quality terminal care
observational study on patients with hiv/aids(ospwh)

Conditions: HIV Infections

Summary: to establish a follow-up cohort of antiretroviral therapy(art) for patients with hiv/aids, to observe the art efficacy and adverse reactions, complications in the process of art, as well as mortality and causes of death, so as to provide basis for further improving art efficacy and quality of life of the patients.

1. to establish a follow-up cohort of art for hiv/aids patients: follow-up points: before treatment and 1, 2, 3 months after treatment, and every 3 months after treatment. 2. to observe the art efficacy and adverse reactions: the clinical manifestations, laboratory and auxiliary examination indexes of each follow-up time point was observed in the follow-up cohort, including blood routine, liver function, renal function, blood lipid, blood glucose, urine routine, plasma hiv rna,cd4 cell count, hepatitis index and syphilis index, etc. if hiv rna is more than 1000 copies/ml, after treatment for more than 6 months, peripheral blood 10ml should be retained and drug resistance should be detected. 3. to investigate the complications of hiv/aids patients before and after art. 4. to investigate the mortality and causes of death in patients with hiv/aids.

Eligibility criteria:
inclusion criteria: * patients has a history of diagnosis of hiv. * receiving antiretroviral therapy. * good treatment compliance. exclusion criteria: * aged less than 14 years of old.

Keywords: hiv/aids art