Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of folfox4 + weekly cetuximab vs folfox 4+biweekly cetuximab by metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: to assess the efficacy of folfox4 in combination with cetuximab, weekly and folfox4 in combination with cetuximab, biweekly.

this multicenter randomized phase ii study will enroll approximately 150 patients with metastatic colorectal cancer. patients are randomized in arm a(folfox4 in combination with weekly cetuximab) or arm b (folfox4 in combination with biweekly cetuximab). both efficacy and safety data will be collected. the investigator will assess response to treatment every 8 weeks based on the imaging. following permanent treatment cessation, patients will be followed-up for survival.

Eligibility criteria:
inclusion criteria: * signed written informed consent * male or female ≥ 18 years of age * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * metastatic colorectal carcinoma not suitable for curative-intent resection- availability of tumor sample (or able and willing to provide tumor sample) for egfr assessment * presence of at least one lesion measurable unidimensionally by ct scan or mri. (target lesion(s) must not lie within an irradiated area) * karnofsky performance status of \> 80 at study entry * leucocytes ≥ 3.0 x 10 9/l and neutrophils ≥1.5 x 10 9/l, platelets ≥ 100 x 10 9/l, and hemoglobin ≥ 9 g/dl. * bilirubin ≥ 1.5 x uln * asat and alat ≤ 2.5 x uln (≤5 x uln if liver metastasis are present) * serum creatinine ≤ 1.5 x uln exclusion criteria: * brain metastasis (known or suspected) * previous chemotherapy for metastatic disease. prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is \> 6 months. * surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry * concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * any investigational agent(s) within 4 weeks prior to entry * previous exposure to egfr-pathway targeting therapy * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months * acute or subacute intestinal occlusion or history of inflammatory bowel disease * pre-existing neuropathy \> grade 1. in case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy ≥ 1. * known grade 3 or 4 allergic reaction to any of the components of the treatment. * any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial) * pregnancy or lactation * inadequate contraception (male or female patients) if of childbearing or procreational potential * known drug abuse/ alcohol abuse * legal incapacity or limited legal capacity * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
symbicort smart satisfaction from patient perspective 2009

Conditions: Asthma

Summary: to characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving symbicort maintenance and reliever therapy (smart) in malaysia.


Eligibility criteria:
inclusion criteria: * have been prescribed symbicort smart (1 or 2 inhalation twice daily) by their dr's for the past 3 months * informed consent exclusion criteria: * symbicort smart treatment \< 3 months * patients requiring short courses of oral steroids more than twice in a month

Keywords: control satisfaction
néevo®/néevodha® p.l.u.s. program (progress through learning, understand & support)

Conditions: Pregnancy

Summary: this is an observational study in which patients who have been prescribed néevo®/néevodha® are invited to participate in surveys about their pregnancy and experiences with néevo®/néevodha®. the purpose of this study is to increase the understanding of the role of l-methylfolate among patients who are candidates for néevo®/néevodha®, provide patients with personalized education and support during their pregnancies, and contribute to the overall understanding of the needs and concerns of women facing intermediate- to high-risk pregnancies.

surveys used to conduct this study will be administered via telephone or online by infomedics, inc., a company with a system for developing such patient-physician feedback programs. participating physicians will ask their patients to participate in the program after néevo®/néevodha® has been prescribed and provide them with a patient brochure containing an introduction to the program and instructions on how to enroll. patients interested in participating self-enroll, take a brief survey before starting their néevo®/néevodha® prescription, and then a follow-up survey 4 weeks after they have started taking néevo®/néevodha®. as patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. patients will also receive a copy of their own reports, to help encourage them to continue taking néevo®/néevodha® as directed. patients will also receive educational materials about diet and nutrition during pregnancy.

Eligibility criteria:
inclusion criteria: * new néevo®/néevodha® start. * only for women who are pregnant and taking brand name néevo®/ néevodha® under a physicians care. exclusion criteria: * patients who are not pregnant. * if participant indicates that she did not get a prescription for néevo®/ néevodha®, she will not be able to complete the survey(s). * for the follow-up survey, if the participant indicates that she has not been taking néevo®/néevodha®, she will not be able to complete the survey( (s).

Keywords: neevo neevo dha l-methylfolate anemia during pregnancy folic acid vitamin b12 prenatal vitamins hemoglobin iron deficiency pregnancy
expanded access to abt-414

Conditions: Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to abt-414 prior to approval by the local regulatory agency. availability will depend on territory eligibility. participating sites will be added as they apply for and are approved for the eap. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: * participant must have epidermal growth factor receptor (egfr) amplification or egfrviii mutation. * health care provider (hcp) must have prior clinical trial experience with abt-414. * the participant must not be eligible for an abt-414 clinical trial. * pediatric participants may be evaluated on a case by case basis.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
a study to evaluate the safety and efficacy of tofacitinib modified release tablets compared to tofacitinib immediate release tablets in adult patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * currently taking a stable dose of methotrexate * no evidence of active or latent or inadequately treated tuberculosis exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease * clinically significant infections within the past 6 months

Keywords: tofacitinib, cp-690,550, janis kinase, jak inhibitor, modified release, xeljanz
the impact of preoperative exercise and nutritional optimization on perioperative outcomes for patients undergoing treatment for rectal cancer: the propel trial

Conditions: Rectal Cancer; Colorectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III

Summary: the purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. the names of the groups in this research study are: * group a: prehabilitation program * group b: usual care

this is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. investigators hope that prehabilitation will result in improved outcomes after surgery. participants will be randomized into one of the study groups: group a: prehabilitation program, or group b: usual care. randomization means that a participant is placed into a group by chance. the research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires. it is expected that about 40 participants will take part in this research study.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years at time of enrollment. * english-speaking. * diagnosis of clinical stage ii-iii rectal cancer. * planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (tnt), or 3) chemotherapy only; and anticipated surgical resection to follow. * able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent. exclusion criteria: * distant metastatic disease known at the time of diagnosis. * functional incapacity (i.e., incapable of performing exercise testing). * comorbid conditions or cognitive/physical impairments that contraindicate exercise. * currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer. * currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial. * currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. this study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.

Keywords: rectal cancer colorectal cancer rectal cancer stage ii rectal cancer stage iii
a first-in-human multi-part phase 1 study in healthy volunteers to evaluate the safety, tolerability, pharmacokinetics, and drug-drug interaction potential of single and multiple doses of alg-097558

Conditions: COVID-19

Summary: a multi-part study of alg-097558 to evaluate safety, tolerability, pharmacokinetics and drug-drug interaction potential after single and multiple doses in healthy volunteers


Eligibility criteria:
inclusion criteria for all subjects: 1. male and female between 18 and 55 years old 2. bmi 18.0 to 32.0 kg/m\^2 3. female subjects must have a negative serum pregnancy test at screening 4. subjects must have a 12-lead electrocardiogram (ecg) that meets the protocol criteria exclusion criteria for all subjects: 1. subjects with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation 2. subjects with a past history of cardiac arrhythmias, risk factors for torsade de pointes syndrome (e.g., hypokalemia, family history of long qt syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc. 3. subjects with a history of clinically significant drug allergy 4. excessive use of alcohol defined as regular consumption of ≥14 units/week 5. unwilling to abstain from alcohol use for 1 week prior to start of the study through end of study follow up 6. subjects with hepatitis a, b, c, e or hiv-1/hiv-2 infection or acute infections such as sars- cov-2 infection 7. subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 ml/min/1.73 m\^2 at screening, calculated by the chronic kidney disease epidemiology collaboration \[ckd-epi\] formula)

Keywords: healthy volunteer
generalized anxiety therapy effectiveness

Conditions: Generalized Anxiety Disorder

Summary: this study will examine the effectiveness of digital cbt versus psychoeducation in improving anxiety for those with generalized anxiety disorder.

this study aims to examine the effectiveness of app-based digital cbt for anxiety compared to psychoeducation in individuals with a diagnosis of generalized anxiety disorder. the primary outcomes are anxiety symptom reduction and remission after 10 weeks.

Eligibility criteria:
inclusion criteria: * adults aged ≥22 years old * score ≥15 on the 7-item generalized anxiety disorder questionnaire (gad-7) * diagnosis of gad * current resident of the usa * oral and written fluency in english * regular access to the internet via a mobile or tablet device using android ( 8 or higher) or ios (13 or higher) * participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the irb-approved informed consent form exclusion criteria: * must not be currently receiving or be expecting to start psychological treatment for anxiety during study participation, or have previously received cognitive behavioral therapy (cbt) or acceptance and commitment therapy (act) for anxiety in the past 6-months (self-report) * if on psychotropic medication, this must be stable for at least 60 days * past or present psychosis, schizophrenia, or bipolar disorder, or current ocd * past 12 months alcohol or substance use disorder of moderate or greater severity * moderate or greater suicide risk * hearing or vision impairment that prevents effective use of the audio-visual content of digital cbt or psychoeducation * intellectual disability or any neurocognitive or neurodevelopmental disorder that would prevent participants from following study procedures * any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities

Keywords: generalized anxiety disorder gad anxiety digital cbt
prognosis of a first-ever stroke in persons living with hiv

Conditions: Cerebrovascular Accident, Acute; HIV

Summary: with aging of the persons living with hiv, cardiovascular diseases now account for substantial mortality and morbidity. stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age. the prognosis of ischemic stroke depends mainly on the care in stroke units in the acute phase of the disease (thrombolysis/thrombectomy). it is important that hiv patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance. it would also be important to know whether hiv patients need specific protocols for stroke emergency management. the study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a stroke unit, whether they are infected or not infected by hiv.


Eligibility criteria:
inclusion criteria: * patients unexposed to hiv: hiv-1 seronegative or patients exposed to hiv: hiv seropositive for over 6 months with or without antiretroviral treatment. confirmed by elisa and western blot tests * admitted for ischemic stroke, defined as a sudden cerebrovascular event confirmed by mri * at least 18 years of age * paired with patients unexposed to hiv, admitted for ischemic stroke, same gender and age exclusion criteria: * antecedents of a symptomatic ischemic or hemorrhagic cerebrovascular event * no social security benefits; * absence of signed informed consent for the study * patients currently pregnant or breast-feeding
nebulized bupivacaine analgesia for cleft palate repair

Conditions: Cleft Palate

Summary: in this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

a written informed consent will be taken from the guardian of children. patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. the study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive; nebulized bupivacaine 0.50% 0.25 mg.kg-1 (group b1) or nebulized bupivacaine 0.50% 0.50 mg.kg-1 (group b2) or same volume of saline placebo (group c).

Eligibility criteria:
inclusion criteria: * children (age 1-7 years) of american society of anaesthesiologists physical status (asa) i-ii * elective cleft palate repair ± cleft lip surgery under general anesthesia . exclusion criteria: * coronary artery disease * hypertension * developmental delay * allergy to study drug
iron supplementation for geriatric hip fractures

Conditions: Hip Fractures; Fragility Fracture; Osteoporotic Fractures

Summary: geriatric hip fracture is an important disease that affects the health life of the elderly in china. geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. and anemia is a common comorbidity. at present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in china. more and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. this study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. the study was a randomized, parallel controlled clinical study. due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. the method of randomization was stratified block randomization. the experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. if there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. the outcomes include 6-minute walk distance, harris score, eq-5d score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.


Eligibility criteria:
inclusion criteria: 1. \>65 years old patients with hip fracture 2. patients with iron deficiency or anemia, * preoperative hemoglobin \ 9g/ dl, * serum ferritin \< 100 ng/ ml or serum ferritin 100-299 ng/ ml or transferrin saturation (tsat) \<20% exclusion criteria: 1. coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, and cardiac device implantation (including cardiac resynchronization) within preoperative 30 days 2. acute coronary syndrome, transient ischemic attack or stroke occurred within 30 days before surgery; 3. refused to sign the consent form to be included in the clinical trial group; 4. can't walk before injury; 5. use erythropoietic preparation within 3 months before surgery and oral iron preparation within 4 weeks 30 days before surgery(\> 100 mg/ day) 6. patients with liver and kidney dysfunction 7. other conditions that the researchers considered inappropriate for inclusion
a pharmacokinetic interaction study between apatinib mesylate and transporter pgp substrate digoxin in advanced solid tumor subjects

Conditions: Advanced Solid Tumor

Summary: apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#vegfr-2#, induces transporter pgp function in vitro. this study in patients with advanced cancer evaluated the effect of apatinib on transporter pgp function by comparing the pharmacokinetics of transporter pgp-specific probe drugs in the presence and absence of apatinib. the probes used substrate digoxin.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of advanced solid tumors. 2. ecog ps score: 0-1; 3. expected survival ≥ 3 months; 4. major organs must function normally, meeting the following criteria: 1. hematology 1. hb≥100 g/l; 2. anc≥1.5×109/l; 3. plt≥90×109/l; 2. blood biochemistry: 1. tbil≤ 1.25×uln; 2. alt and ast≤2.5×uln; 3. alp≤2.5×uln; 4. serum cr ≤ 1.5 × uln or endogenous crcl ≥ 60 ml/min (cockcroft-gault formula); 5. albumin \> 30 g/l; 6. k+\>3.0mmol/l; 5. able to understand and sign an informed consent form (icf). exclusion criteria: 1. primary liver cancer; gastric cancer; 2. active brain metastasis (medically uncontrolled), carcinomatous meningitis, spinal cord compression; 3. presence of clinically symptomatic third space fluid; 4. uncontrolled hypertension (sbp ≥ 140 mmhg and/or dbp ≥ 90 mmhg despite optimal pharmacological treatment); 5. uncontrolled clinically significant heart disease, including but not limited to the following: (1) \>2 nyha 2 congestive heart failure; (2) left ventricular ejection fraction (lvef) \< 50% (3) heart rate \<60 (4) grade ii or greater myocardial ischemia or myocardial infarction(5) qtc interval ≥ 450 ms in males and ≥ 470 ms in females; 6. abnormal coagulation function; 7. prior radiotherapy, systemic chemotherapy (\ ctc-ae grade 1; 8. history of psychotropic substance abuse, alcoholism or drug abuse; 9. use of study drugs in other clinical trials within 4 weeks prior to the first dose； 10. use of a potent cyp3a4 inhibitor or inducer within 2 weeks prior to the first dose; 11. use of any prescription or over-the-counter medication, vitamin products or herbs within 2 weeks before taking the investigational drug; 12. other factors that may lead to the termination of the participation in the study at the discretion of the investigators.