Kornimate/medical-research-clean huggingface dataset:
pf-00299804 in patients with head and neck squamous cell carcinoma

Conditions: Head Neck Cancer Squamous Cell Metastatic; Head Neck Cancer Squamous Cell Recurrent

Summary: epidermal growth factor receptor (egfr) is often over-expressed, and have been related to poor prognosis in patients with hnscc. egfr targeting strategies showed clinical anti-tumor efficacy in patients with hnscc. pf-00299804 is a second-generation quinazoline-based irreversible pan-her inhibitor. in preclinical studies, pf-00299804 has much lower ic50 values than gefitinib in cell lines engineered to express egfrviii mutations (1.2 nm versus 2,700 nm) and produces tumor growth inhibition in gefitinib-resistant xenografts. a phase ii trial of pf-00299804 in patients with recurrent or metastatic hnscc is currently ongoing and preliminary report in asco 2010 showed its anti-tumor activity against hnscc. the investigators suggest a phase ii trial of pan-her inhibitor pf-00299804 in patients with recurrent or metastatic hnscc previously treated with platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of head and neck * age ≥ 18 * ecog ps 0-2 * documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab * at least one bidimensionally measurable disease * adequate organ function for treatment * availability of tumor tissue for molecular analysis (archival or rebiopsy tissue) exclusion criteria: * nasopharyngeal carcinoma * eligibility for local therapy (surgery or radiotherapy) * previous treatment with small molecule egfr tyrosine kinase inhibitors * more than one systemic chemotherapy * any major operation or irradiation within 4 weeks of baseline disease assessment * any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug * cns metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment * patients with known interstitial lung disease * patients with uncontrolled or significant cardiovascular disease (ami within 12 months, unstable angina within 6 months, nyha class iii, iv congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, congenital long qt syndrome, any significant ventricular arrhythmia, any uncontrolled second or third degree heart block, uncontrolled hypertension) * concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ) * pregnant or breast-feeding women * other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Keywords: pf-00299804, head and neck cancer, squamous cell carcinoma
long-term study to assess the safety and tolerability of nbi-1065845 as an adjunctive treatment in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this study will evaluate the long-term safety and tolerability of nbi-1065845 as an adjunctive treatment in participants with mdd.


Eligibility criteria:
key inclusion criteria: * participant has a primary diagnosis of recurrent mdd (moderate or severe) or persistent depressive disorder. * participant has had an inadequate response to oral antidepressant treatments in the current episode of depression. * participant must have been taking oral antidepressants for at least 8 weeks prior to screening. * willing and able to comply with all study procedures and restrictions in the opinion of the investigator. key exclusion criteria: * a current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than mdd. * are considered by the investigator to be at imminent risk of suicide or injury to self or others. other protocol defined inclusion and exclusion criteria apply.

Keywords: mdd depression major depressive disorder nbi-1065845 tak-653
rct glargine vs nph for treatment of dm in pregnancy

Conditions: Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus (T2DM); Gestational Diabetes Mellitus, Class A2

Summary: we are asking you to take part in this research study because you are diagnosed with pregestational type 2 diabetes mellitus or gestational diabetes mellitus requiring insulin therapy in pregnancy. currently, many hospitals differ among use of insulin for management of dm in pregnancy, with nph, glargine and detemir being the most commonly used forms of basal insulin. outside of pregnancy, nph is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. detemir has been well studied in pregnancy and found to be noninferior to nph. unfortunately, glargine has not been as well studied in pregnancy. thus, with this study we want to compare glargine and nph. the purpose of this study is to compare two different forms of insulin (glargine and nph) that we regularly use to manage diabetes mellitus in pregnancy.

this is an open-label, noninferiority, prospective randomized study. patients will be randomized to either be treated with nph insulin for management of diabetes mellitus in pregnancy, or with glargine insulin. we will include all pregnant patients managed by the maternal fetal medicine team at loyola university of medical center that have pregestational type 2 diabetes mellitus or gestational diabetes mellitus requiring insulin. our primary outcome is hypoglycemia. we provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events. patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in myloyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance. the study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the rct.

Eligibility criteria:
inclusion criteria: * patient requiring initiation of insulin therapy for gestational diabetes mellitus or type 2 diabetes mellitus in pregnancy * at least 18 years old * insulin started prior to 34 weeks gestation * established prenatal care by 14 weeks gestation exclusion criteria: * those under the age of 18 years old * those unable to consent in english * allergy to insulin * controlled with only diet modification or the use of oral antihyperglycemics * has diagnosis of type 1 diabetes mellitus * receiving insulin through an insulin pump

Keywords: glargine nph hypoglycemia
active matrix metalloproteinase-8 (ammp-8) chair-side test in different periodontal disease

Conditions: Periodontal Diseases

Summary: the aim of this study to evaluate the diagnostic accuracy of a new qualitative ammp-8 poc test in different periodontal health and disease and as compared to the established quantitative laboratory method (elisa)

mmp-8 has been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. a positive ammp-8 test could be an early indicator of these excessive and undesired tissue reactions.

Eligibility criteria:
inclusion criteria: * systemically healthy * nonsmokers exclusion criteria: * participants were not included if they had systemic disease such as diabetes, cardiovascular. * participants who took regular medications that could affect of periodontal tissue * participants who received antibiotics less than 10 weeks before the study

Keywords: aggressive periodontitis healthy peri-implant chairside test chronic periodontitis
the durable trial: evaluating the durability of starter insulin regimens in patients with type 2 diabetes (ioov)

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare insulin lispro low mixture \[lm\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro lm to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. this study will also determine whether the safety of insulin lispro lm and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. the addendum study (intensification addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro lm or insulin glargine.


Eligibility criteria:
inclusion criteria: * must have type 2 diabetes. * must be at least 30 and less than 80 years of age at the time of visit 1. * must be on at least two oral antidiabetes medications for at least 90 days. * must have an hba1c 1.2 to 2.0 times the upper limit of normal reference range at the local lab. exclusion criteria: * must not have used insulin on a regular basis in the last 12 months. * must not have had more than one episode of severe hypoglycemia in the last 24 weeks. * must not have a body mass index (bmi) of greater than 45 (morbid obesity). * must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease. * must not be pregnant or intend to get pregnant during course of the study.

Keywords: diabetes type 2
clinical study to assess the efficacy and safety of thvd-201 in patients with oab

Conditions: Overactive Bladder

Summary: the primary purpose of this study is to assess the efficacy and safety of thvd-201(combination of tolterodine and pilocarpine) in patients with overactive bladder during the period of treatment, 12 weeks. this study also includes an open label extension period of an additional 12 weeks following the treatment to assess long-term efficacy and safety of thvd-201 in patients with overactive bladder.


Eligibility criteria:
inclusion criteria: * 20 - 85 years * history of oab (pure urge or mixed urinary incontinence with predominant urge incontinence) for ≥ 6 months. * in the case of females, at least 2 years has passed since menopause. or all pre-menopausal female subjects must have been using a highly effective method of birth control during the study. subject of childbearing potential must have had a negative pregnancy test prior to enrollment. exclusion criteria: * predominate stress incontinence, insensate incontinence (those incapable of distinguishing discrete incontinence episodes) and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator. * history of neurogenic bladder. * pvr \> 200ml * history of clinically significant renal disease or estimated creatinine clearance defined by cockcroft and gault formula \< 30 ml/min. * history of malignant tumor within the past 5 years. * history or presence of tachyarrhythmia or cardiac disease that in the opinion of the investigator might have confounded the results of the study or posed additional risk to the subject. subjects who had a value for qtc \> 450 msec at the screening visit. * patient with asthma * psa ≥ 10 ng/ml in male who is 50 years and over.

Keywords: overactive bladder tolterodine (detrusitol) pilocarpine
effects of lightweight meshes in laparoscopic inguinal hernia repair on quality of life and male fertility aspects

Conditions: Inguinal Hernia

Summary: a randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.


Eligibility criteria:
inclusion criteria: * primary, unilateral or bilateral, inguinal hernia patients * informed consent exclusion criteria: * sterilized patients

Keywords: inguinal hernia laparoscopic repair prostheses male fertility
first human dose study of anti-il-20 in psoriasis: a study of safety, tolerability and early signals of biologic and clinical effects

Conditions: Inflammation; Psoriasis

Summary: this trial is conducted in the united states of america (usa). the aim of this clinical trial is evaluate the safety and tolerability of anti-il-20 in patients with psoriasis and to determine the preliminary efficacy in an expansion phase of this trial. this trial consists of 3 parts: a single dose (sd) dose-escalation phase for 16 weeks, a multiple dose (md) dose-escalation phase for 22 weeks, and a md expansion phase for 22 weeks. initiation of the md expansion phase will depend on results from the sd and md dose-escalation phases and only if an acceptable safety profile is present. subjects participating in the expansion phase are not allowed to have participated in the previous phases (sd and md dose-escalation phases) of the trial.


Eligibility criteria:
inclusion criteria: * subjects with moderate to severe stable chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis * affected body surface area (bsa) greater than or equal to 15% * physician's global assessment (pga) score of 3 or more * female subjects of non-childbearing potential or postmenopausal for at least 1 year. male subjects must agree to use effective method of birth control * body mass index (bmi) less than or equal to 38.0 kg/m2 exclusion criteria: * concomitant anti-psoriatic treatment * infectious disease requiring systemic anti-infectious treatment within the 2 weeks prior to administration of trial drug * known history of human immunodeficiency virus (hiv) * hepatitis b and/or c (determined by test) * live virus or bacteria vaccines within the last month before drug administration * known active herpes/herpes zoster/cold sores * kidney insufficiency * liver insufficiency * lymphoproliferative disease * history or signs of malignancy within the last 5 years
percutaneous coronary intervention with the angiolite drug-eluting stent: an optical cohenrece tomography study

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel angiolite drug-eluting stent (ivascular, barcelona, spain) utilizing intracoronary optical coherence tomography (oct).

this is a prospective registry including patient scheduled for a clinically-indicated percutaneous coronary intervention (pci) of a de novo epicardial lesion with indication for drug-eluting stent implantation. following study enrolment and pci/stent with the angiolite des, patients will be scheduled for follow-up surveillance coronary angiography and oct with the c7-xrtm fourier domain oct system with c7 dragonflytm catheter (st jude medical, minneapolis, mn) or with the terumo lunawaytm oct system with fastview catheter (terumo medical corporation, tokyo, japan). an adaptive design component of the study will randomize patients to either 3-month or 6-month angio/oct follow-up. clinical follow-up will occur at 30 days, 3 months, 6 months, 12 months and 24 months post pci.

Eligibility criteria:
inclusion criteria: * patients scheduled for clinically-indicated pci of a de nove epicardial lesion, including those with chronic stable angina, acs (defined as nstemi or acs with negative cardiac enzymes) or in the setting of elective pci. * indication for des implantation * target lesion must have visually estimated stenosis ≥50% and one of the following: stenosis ≥70% or evidence of ischemia * strong preference for single stent coverage per lesion, but if unexpected clinically indicated second stent placement with overlap is needed, these patients will not be excluded from optical coherence tomographic follow-up * target lesion, if possible, should be predilated/pretreated exclusion criteria: * age \>85 years * acute st segment elevation mi (stemi) * cardiogenic shock * known left ventricular ejection fraction \<30% * contraindication for dual antiplatelet therapy (dapt) for at least 6-month duration * iodinated contrast allergy * renal impairment with serum creatinine \>2.0 mg/dl * anticipated medical non-compliance * life-expectancy \<12 months * chronic total occlusion (cto) in the target vessel * bifurcation lesion requiring a two-stent strategy * in-stent restenosis * severe lesion/segment angulation/tortuosity * severe vessel/lesion calcification * simultaneous pci within the same or different vessel during the same procedure * lesion unsuitable for oct (proximal lesions \<10 mm from ostium of left main or right coronary arteries) * lesion length \>18 mm * stent length \>24 mm * stent diameter ≤2.5 mm and \> 4.0 mm * unprotected left main coronary artery disease (≥50% diameter stenosis) * \>1 lesion * planned use of 2 overlapping stents
a study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of subcutaneous azd6912 in healthy participants

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of single ascending doses of azd6912 administered subcutaneously (sc) in healthy participants.

in this first-in-human (fih) study, eligible participants will be randomly assigned to 6 cohorts in a 3:1 ratio to receive either a single dose of azd6912 sc or placebo. the first 2 participants in each cohort will be dosed as a sentinel pair, with one receiving azd6912 sc and the other receiving placebo. the study will comprise of, a screening period of 70 days, a treatment period where participants will stay at the clinical unit from the day before study intervention administration until at least 240 hours and will be discharged on day 11. outpatient visits would start weekly from day 15, then bi-weekly from day 43, 4-weekly from day 99, and 6-weekly from day 155, with additional follow-up visits approximately every 4 weeks as needed until complement activity returns to the normal range. the study will last approximately 25 months, including the optional japanese cohorts, with each participant participating for about 38 weeks or longer until complement activity returns to normal range (per local laboratory).

Eligibility criteria:
inclusion criteria: * females must have a negative pregnancy test. * contraceptive use by males and females should be consistent with local regulations. * have a body mass index (bmi) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg. * for optional japanese participants only: * participants must be of japanese descent defined as: first generation (born to 2 japanese parents and 4 japanese grandparents). * born in japan, and not have lived outside japan for more than 5 years. * lifestyle, including diet, must not have significantly changed since leaving japan. exclusion criteria: * history of any clinically important disease or disorder. * current or recurrent disease of clinical significance that could affect clinical assessments or clinical laboratory evaluations. * any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention. * history of congenital or acquired immunodeficiency or complement deficiency or an underlying condition that predisposes to infection. * history of any neisseria infection, unexplained, recurrent infections, or infection requiring treatment with systemic antibiotics. * evidence of hepatitis b infection (positive for hbsag or positive for anti-hbcab) or hepatitis c viral infection (hcv abs or hepatitis c rna positive) or hiv infection (positive for hiv type 1 or type 2 abs). * participants testing positive for covid-19 prior to dosing. * any cardiac abnormalities. * a cap activity \< 60% at screening. * known or suspected history of drug abuse, history of alcohol abuse or smoking.

Keywords: complement factor b small interfering ribonucleic acid cfb messenger ribonucleic acid
feasibility and safety of early discharge after transfemoral transcatheter aortic valve implantation

Conditions: Aortic Stenosis

Summary: the hypothesis behind this study is that there is a proportion of patients considered high or intermediate risk for surgery, but relatively low risk for tavi, which can be discharged early after the procedure (within the first 2-3 days) without additional risks. therefore, when performed in safety, an early discharge may cut periprocedural tavi costs significantly.

tavi (transcatheter aortic valve implantation) - a viable alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis. considered as being at unacceptable surgical risk. despite its widespread utilization, there are procedure specific complications and hospitalization associated costs that limit tavi expansion into patient populations with lower risk. cost-effectiveness of tavi has been investigated either compared with standard therapy for patients who are not candidates for surgical valve replacement or with conventional surgical replacement in high-risk patients. formal economic evaluation in inoperable patients demonstrated that the benefits of tavi were achieved at an acceptable incremental cost to society, at least in the context of the u.s. and u.k. health systems. in patients with severe, symptomatic as who are at high but not prohibitive surgical risk, the partner a trial demonstrated that tavi appeared to be an economically attractive strategy compared with aortic valve replacement, provided that patients are suitable for a transfemoral approach. on the other hand, results for trans-apical tavi compared with surgical replacement were economically unfavorable.

Eligibility criteria:
inclusion criteria: * none exclusion criteria: * none * beyond the applicable criteria of the ifu no further in- and exclusion criteria are defined.