Kornimate/medical-research-clean huggingface dataset:
study of jdq443 in patients with advanced solid tumors harboring the kras g12c mutation

Conditions: KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small-Cell Lung; Carcinoma, Colorectal; Cancer of Lung; Cancer of the Lung; Lung Cancer; Neoplasms, Lung; Neoplasms, Pulmonary; Pulmonary Cancer; Pulmonary Neoplasms

Summary: this is a phase ib/ii open label study. the escalation part will characterize the safety and tolerability of jdq443 single agent and jdq443 in combination with the other study treatments (tno155 and tislelizumab) in advanced solid tumor patients. after the determination of the maximum tolerated dose / recommended dose for a particular treatment arm, dose expansion will assess the anti-tumor activity and further assess the safety, tolerability, and pk/pd of each regimen at the maximum tolerated dose / recommended dose or lower dose.


Eligibility criteria:
inclusion criteria: * adult patients with advanced (metastatic or unresectable) kras g12c mutant solid tumors who have received standard of care or are intolerant or ineligible to approved therapies * ecog performance status of 0 or 1 * at least one measurable lesion as defined by recist 1.1 * prior treatment with a kras g12c inhibitor may be allowed for dose escalations of combinations and a subset of groups in dose expansion exclusion criteria: * tumors harboring driver mutations that have approved targeted therapies, with the exception of kras g12c mutations * symptomatic brain metastases or known leptomeningeal disease. patients with asymptomatic treated or untreated brain metastases may be eligible * clinically significant cardiac disease or risk factors at screening * a medical condition that results in increased photosensitivity other protocol-defined inclusion/exclusion criteria may apply.

Keywords: kras kras g12c metastatic cancer advanced cancer enzyme inhibitor pd-1 shp2 targeted therapy non-small-cell lung cancer colorectal cancer molecular mechanisms of pharmacological action
a study of xolair (omalizumab) in patients with chronic idiopathic urticaria (ciu) who remain symptomatic with antihistamine treatment (h1)

Conditions: Chronic Idiopathic Urticaria

Summary: the study is a phase ii, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with ciu and remain symptomatic despite treatment with therapeutic doses of an h1 antihistamine. the study will enroll approximately 76 patients at approximately 45 study centers in the united states and germany.


Eligibility criteria:
inclusion criteria: * ciu diagnosis \> 3 months (by history) * no underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria) exclusion criteria: * pregnant, breastfeeding, or women not taking contraception * patients \< 40kg * treatment with any investigational agent within 30 days of screening * recent history of drug or alcohol abuse * atopic dermatitis or other skin disease associated with pruritus * clinically relevant major systemic disease (making interpretation of the study results difficult) * previously treated with omalizumab (\< 12 months since last injection) * patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, ivig, or plasmapheresis * patients may not have been taking doxepin within the past 6 weeks regular (daily/every other day).

Keywords: xolair ciu
the use of floseal to reduce bleeding in total knee replacement surgery

Conditions: Blood Loss

Summary: the purpose of this study is to determine if the agent, floseal, can decrease the amount of blood patients lose after total knee replacement (tkr) surgery. if this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. the subject's overall participation will be over a period of 6 weeks.

this is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. the patients will be randomized intra-operatively to receiving floseal or no treatment. both the patient and the observers will be blinded to whether the subject received floseal or no treatment. only the operating surgeons will be aware of whether floseal or no treatment was given. as was performed in the pilot study, randomization of floseal or no treatment will be performed using the sealed envelope technique. randomization will occur at the time of surgery. the statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. the inner envelope will contain whether floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. the inner envelope will then be sealed, followed by sealing of the outer envelope. following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. the patients study number will be on the outside surface of the envelopes.

Eligibility criteria:
inclusion criteria: * single knee replacement for arthritis of the knee exclusion criteria: * no inflammatory arthritis (ie. rheumatoid arthritis) * no allergies to cow meat (bovine allergies * no history of bleeding disorders

Keywords: to decrease blood loss during knee surgery
study of dupilumab administered to adult patients with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
the inclusion criteria included, but were not limited to, the following: 1. chronic atopic dermatitis that had been present for at least 3 years 2. history of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable (e.g, because of important side effects or safety risks) 3. willing and able to comply with all clinic visits and study-related procedures the exclusion criteria included, but were not limited to, the following: 1. prior treatment with dupilumab (regn668/sar231893) 2. presence of certain laboratory abnormalities at the screening visit 3. treatment with an investigational drug within 8 weeks of baseline visit 4. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit 5. certain other treatments and medical procedures undertaken within a particular time frame prior to the baseline visit 6. known history of human immunodeficiency virus (hiv) infection 7. history of malignancy within 5 years before the baseline visit (with certain exceptions) 8. planned surgical procedure during the length of the study 9. high risk of parasite infection 10. any other medical or psychological condition that in the opinion of the investigator or the sponsor's medical monitor, would place the participants at risk, interfere with participation in the study or interfere with interpretation of study results 11. pregnant or breast-feeding women

Keywords: eczema
efficacy of intracavernous platelet-rich plasma injection in the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: investigation of the efficacy of autologous platelet-rich plasma administration on the potency of patients with vasculogenic and/or neurogenic erectile dysfunction


Eligibility criteria:
inclusion criteria: - 1)40-70 years old male, sexually active heterosexual, 2) patients with a diagnosis of mild to moderate erectile dysfunction (iief score between 8-21) according to the international index of erectile function (iief) for at least 3 months, 3) patients who cannot achieve an erection despite peroral pde5 inhibitor and intracavernous alprostadil injection therapy exclusion criteria: 1. patients with psychogenic erectile dysfunction, 2) patients with a history of priapism, penile fracture, peyronie, penile curvature 3) patients with a history of radical prostatectomy, 4) patients with a history of major pelvic trauma, surgery, radiotherapy, 5) patients with a history of malignancy affecting survival, 6) patients with severe psychiatric illness that impairs adherence to treatment, 7) patients with any bleeding disorder or on anti-aggregants/coagulants.

Keywords: platelet-rich plasma erectile dysfunction
diagnostic accuracy of a host-response based diagnostic tool for distinguishing between bacterial and viral etiologies in pediatric patients

Conditions: Fever; Respiratory Tract Infections

Summary: this is a prospective clinical validation study of a novel regulatory approved (ce-ivd) diagnostic assay called immunoxpert™ that will enroll 1222 pediatric patients. the study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of immunoxpert™. additionally, statistical analysis will be performed to compare immunoxpert™ accuracy to current practice lab testing (e.g. wbc, crp, and pct) and clinical suspicion at time of requisition. enrolled patients will be managed according to the current standard of care and per standard institutional procedures.


Eligibility criteria:
inclusion criteria: * legal guardian signs an informed consent * documented peak temperature ≥ 38°c (100.4°f) * symptom duration ≤ 7 days * clinical suspicion of rti (or) fever without a clear source after clinical examination exclusion criteria: * another episode of febrile infection within the past 2 weeks * antibiotic treatment of over 48 hours * congenital immune deficiency (cid) * a proven or suspected hiv, hbv, hcv infection * active malignancy * current treatment with immune-suppressive or immune-modulating therapies, including without limitations: * use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the past two weeks * monoclonal antibodies, anti-tnf agents * intravenous immunoglobulin (ivig) * cyclosporine, cyclophosphamide, tacrolimus * g/gm-csf, interferons * other severe illnesses that affect life expectancy and/or quality of life such as: * severe psychomotor retardation * post-transplant patients * severe congential metabolic disorder
lumigan® in patients with primary open angle glaucoma (poag) or ocular hypertension (oht)

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this is an observational study of lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with primary open angle glaucoma (poag) or ocular hypertension (oht).


Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma or ocular hypertension * prescribed lumigan® exclusion criteria: * none
efficacy of pentoxifylline as add on therapy in covid19 patients

Conditions: COVID

Summary: with potential antiviral effects on severe acute respiratory syndrome (sars) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. as the main regulator of camp metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as tnf-a, il-1 and il-6. given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for covid-19 patients.


Eligibility criteria:
inclusion criteria: * positive covid-19 test * age \>/= 18 y.o. exclusion criteria: * allergic reaction to pentoxifylline * ongoing anticoagulation * history of gi bleeding * history of seizures * cardiac or other vascular stents * history of severe renal disease * history of intracranial hemorrhage.
bay2328065 single dose escalation, safety and tolerability, pharmacokinetics, relative bioavailability, food effect

Conditions: Endometriosis

Summary: this single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of bay2328065


Eligibility criteria:
inclusion criteria: * healthy male volunteers, aged 18 - 45 years * body mass index (bmi): 18 ≤ bmi ≤ 30 kg/m² * smoking less than 10 cigarettes / day * signed informed consent * use of an accepted method of contraception for the duration of the study. exclusion criteria: * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors * known severe allergies, non allergic drug reactions, or multiple drug allergies * medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters * clinically relevant findings in physical examination; ecg, blood pressure; laboratory values
cognitive and physical exercise (cope) prehabilitation pilot feasibility study

Conditions: Cognitive Impairment; Physical Impairment; Postoperative Complications

Summary: cognitive and functional impairment are debilitating problems for survivors of major surgery. efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. an area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. no work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. it is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. the primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. the secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.


Eligibility criteria:
inclusion criteria: * adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery exclusion criteria: * blind, deaf, or unable to speak english, as these conditions would preclude our ability to perform the proposed cognitive and physical program * pregnancy * prisoners * severe frailty or physical impairment that prohibits participation in prehabilitation program * patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation * less than 2 weeks from scheduled surgery * patients without home internet access
a phase ii/iii trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine in metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: to evaluate the efficacy of surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

this is a multicenter, randomized, open-label, active-controlled, phase ii/iii trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Eligibility criteria:
inclusion criteria: 1. fully understand and voluntarily sign an informed consent form, willing and able to follow the study process; 2. age range is 18-75 years old (inclusive); 3. pancreatic cancer confirmed by histology or cytology; 4. stage iv metastasis pancreatic cancer patients; 5. have not received previous systematic anti-tumor treatment in the stage of metastatic pancreatic cancer; 6. according to recist 1.1, there is at least one measurable lesion; 7. eastern cooperative oncology group (ecog) performance status score of 0 or 1; 8. expected survival time ≥ 12 weeks; exclusion criteria: 1. use of systematic anti-tumor therapy within 4 weeks prior to the first dose； 2. presence of other malignancies in the past 3 years; 3. received major surgical surgery within 60 days before the first dose; 4. have received any surgery or invasive treatment within 4 weeks before the first use of the drug; 5. received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose; 6. any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine; 7. received inducers or inhibitors of cytochrome p450 (cyp) 3a and cyp2c8 within 2 weeks or 5 half-lives (whichever is longer) before the first dose; 8. use of immunosuppressive drugs within 4 weeks before first dose; 9. known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis; 10. patients who currently have hypertension that cannot be controlled by medication;

Keywords: first-line treatment in patients
nutritional and anti-infective interventions for malnutrition in pregnancy (beleuman welbodi)

Conditions: Pregnancy; Malnutrition in Pregnancy; Nutrition Disorders; Stunting

Summary: acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. the benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. this study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. the outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.


Eligibility criteria:
inclusion criteria: * pregnant women and consenting to study participation * fundal height not greater than 32 cm * mid-upper arm circumference ≤23 cm * planning to reside in the study area during pregnancy and 6 months post partum * attending 1 of the 40 antenatal clinic sites exclusion criteria: * \< 16 years of age without adult willing to consent * known pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension
treatment goals in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the pagopsa study objective is to ascertain if guideline-based psoriatic arthritis clinical care achieves individual patient goals as articulated by patients, and to identify predictors of achieving individual patient goals from psoriatic arthritis treatment.

psoriatic arthritis (psa) is a heterogeneous autoimmune disease that occurs in one in three people with the skin disease psoriasis. psa can cause arthritis (joint inflammation), enthesitis (tendon and ligament inflammation), sausage digits (swollen entire finger or toe), spondyloarthritis (spinal inflammation). skin involvement by psoriasis is also highly variable in terms of psoriasis type and location. through combined skin and musculoskeletal involvement, psoriatic disease has a significant life impact with decrease quality of life including uncomfortable symptoms, ability to participate in life and functioning. medications used to treat psa have sometimes an uneven effect on the various psa manifestations where some are more effective for skin while others more effective for the joints. in this context, clinical care and treatment of psa is a complex process which balances disease activity with medication risks and benefits as well as patient priorities. professional psa treatments guidelines state that psa treatment goals are disease remission or low disease activity. several studies to date have shown that physicians tend to overestimate remission and low disease activity in psa patients when compared to disease activity indices. also patients and physicians frequently do not align on perceptions of remission or low disease activity. in the proposed study the investigators aim to identify predictors of successful treatment from a patient perspective on a range of disease measures including psoriasis, arthritis, enthesitis, dactylitis, patient reported outcomes, and laboratory assessments which are routinely collected in the clinical care of psa. secondary endpoints are to quantify longitudinally how stable a state of treatment success is from a patient perspective, and to define score ranges for disease measurements, including health-related quality of life measures, that correspond to treatment success from a patient perspective. the impact of this research is that the investigators will be able to define parameters predictive of achieving treatment success from a patient perspective, which will then inform goals of care for psoriatic arthritis.

Eligibility criteria:
inclusion criteria: * english speaking/reading adults * patients of the johns hopkins arthritis center and/or the johns hopkins psoriatic arthritis clinical program * followed every 3-4 months for regular psoriatic arthritis clinical care * meet classification criteria for psoriatic arthritis (caspar) * able to interact with touch screen computer. exclusion criteria: none

Keywords: patient treatment goals
pilot study of the effects of erythritol on endothelial function in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the study will determine whether acute and chronic consumption of a beverage containing erythritol will improve endothelial function in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * otherwise healthy exclusion criteria: * pregnant * bmi\>35 kg/m2 * long acting insulin treatment * other major illness, drug abuse * treatment with an investigational drug within 12 weeks * treatment with dietary or vitamin supplements * smoking within 3 months

Keywords: endothelium diabetes mellitus oxidative stress