Kornimate/medical-research-clean huggingface dataset:
neoadjuvant osimertinib + chemotherapy for egfr-mutant stage iii nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this is a phase ii, single-arm, multi-center study of neoadjuvant osimertinib in combination with chemotherapy for the treatment of patients with resectable egfr-mutant stage iii (n2) non-squamous non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented n2 positive non-squamous nsclc with resectable (stage iiia or t3-4n2 iiib) disease (according to version 8 of the iaslc cancer staging manual \[iaslc staging manual in thoracic oncology 2016\]). * complete surgical resection of the primary nsclc must be deemed achievable, as assessed by a mdt evaluation (which should include a thoracic surgeon, specialized in oncologic procedures). * eastern cooperative oncology group (ecog) ps of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing * a tumour which harbours one of the 2 common egfr mutations known to be associated with egfr-tki sensitivity (ex19del, l858r), either alone or in combination with other egfr mutations (ie, t790m, g719x, exon20 insertions, s7681 and l861q). exclusion criteria: * past medical history of ild, drug-induced ild, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ild. * history of another primary malignancy, except for the following: malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (ip) and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; adequately treated carcinoma in situ without evidence of disease * patients who have pre-operative radiotherapy treatment as part of their care plan * mixed small cell and nsclc histology * t4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky n2 disease deemed unresectable * patients who are candidates to undergo only segmentectomies or wedge resections * prior treatment with any systemic anti-cancer therapy for nsclc including chemotherapy, biologic therapy, immunotherapy, or any investigational drug * prior treatment with egfr-tki therapy * current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome p450 (cyp) 3a4 (at least 3 weeks prior)

Keywords: non small cell lung cancer neoadjuvant egfr-tki
cardiac rhythm disturbances in hard-to-treat epilepsy patients using loop ecg recorders

Conditions: Epilepsy

Summary: seizure-related cardiac arrhythmias are one of the possible causes of sudden unexpected death in epilepsy (sudep). identification of these patients is challenging because cardiac rhythm disturbances could emerge only during seizures. furthermore, patients could have transitioned sinus or av node blocks which could cause syncopes with brady-related seizures which could be treated as epilepsy-related seizures. implantable loop recorders have an ability to recording single-channel ecg for up to 36 months which give an ability to detect these heart disturbances. the purpose of this study is to look the incidence and types of arrhythmias which occur in 150 patients with hard-to-treat partial seizures and secondarily generalized seizures


Eligibility criteria:
inclusion criteria: 1. hard-to-treat focal epilepsy 2. aged 18 to 60 years 3. if female not pregnant exclusion criteria: 1. known clinical relevant structural cardiac disease 2. implanted pacemaker, including cardiac resynchronisation device, or defibrillator 3. use of beta blockers or other antiarrhythmic medication 4. diagnosis of psychogenic non-epileptic seizures

Keywords: epilepsy heart block sudden cardiac death loop recorder
haptoglobin phenotype and cardiovascular complications in diabetic patients

Conditions: Diabetes; Cardiovascular Disease; Myocardial Infarction

Summary: 3054 diabetic patients were screened for haptoglobin phenotype as part of the icare study (nct00220831) and composite the i care registry, 1434 hp 2-2 patients were treated as part of the i care study with vitamin e vs. placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication. all other patients were passively followed since april 2005 for cardiovascular events. we have decided to continue and follow these patients till end of december 2007 to determine the incidence of cvd in theses patients which are pre stratified by haptoglobin phenotype.

3054 diabetic patients from clalit medical services were screened for haptoglobin phenotype as part of the icare study (nct00220831) and composite the i care registry, 1434 hp 2-2 patients were treated as part of the i care study with vitamin e vs. placebo, this study was recently terminated due to significant differences between the groups and data was sent to publication. during the follow up period of the i care study all 3054 registry patients were followed in a passive way, which means that the patients were not called for follow up visits but the reports for cvd events were centrally collected from patient's hospital admission summaries. admission summaries were collected using the computerized systems of the clalit health services assuring that when ever a patient in the registry is hospitalized for what ever reason the study coordination them would be aware of that and receive the admission summary. an events adjudication committee adjudicated each event in a blinded fashion to determine the nature of the events. 1434 patients who were treated by vitamin e or placebo in the i care study were also followed by follow-up telephone calls. once i care study was officially terminated we have decided to continue and follow the whole 3054 registry patients in the same manner to complete a nearly 3 year follow up to determine in a prospective manner the incidence of cvd events in diabetic patients which were pre-stratified by haptoglobin type.

Eligibility criteria:
these are the same patients as in i care registry so the criteria are the same as was for i care study recruitment phase. inclusion criteria: * diabetic patients aged 55 and above exclusion criteria: * patient who takes antioxidant treatment will be asked to stop, or can't be included in the study * patients who had a cvd incident (mi, stroke, tia), unstable angina pectoris, uncontrolled htn, will have to wait a month after stabilization to be included in the study * allergy to vitamin e

Keywords: diabetes cardiovascular disease haptoglobin
predictors of the long-term functional benefits of a pulmonary rehabilitation program?

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (copd) undergoing pulmonary rehabilitation (pr), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-pr and hrqol, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.


Eligibility criteria:
inclusion criteria: 1. patients over the age of 40 will be eligible if 2. they are diagnosed with moderate-severe copd, 3. currently participate to a pr program, and 4. agree to participate. exclusion criteria: they will be excluded if: 1. they have any comorbidity that is more important (i.e., more likely to cause morbidity or mortality) than copd (e.g., active cancer), 2. they have contraindications to exercise (though they will not likely be referred to pr), 3. they have participated in a pr program in the past year, 4. and if they are unable to provide informed consent due to language difficulties or cognitive impairment.

Keywords: pulmonary rehabilitation chronic obstructive pulmonary disease psychiatric disorders
ovarian histopathology and laparoscopic assessment of premature ovarian failure

Conditions: Premature Ovarian Failure

Summary: 25 women with premature ovarian failure who attended fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group). \*pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation for assessment of autoimmune oophoritis, sections were immunostained with anti-lca (cd45) monoclonal antibody

25 women with premature ovarian failure who attended fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group).pelvic laparoscopy and ovarian biopsy to be examined histologically. all procedures were performed under general anesthesia the utero-ovarian ligament was stabilized with the round biopter introduced through the other. the round metal biopter 5 mm in diameter with an inner protective trocar. the tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. after correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness. the round biopter was removed, and a grasper was introduced to recover the excised tissue. ovarian biopsy specimens were fixed in 10% formalin and embedded in paraffin forming tissue blocks. two sections, 4μ thick were cut from each block. one was stained with routine haematoxylin and eosin (h\&e) stain while the other was immunostained with anti-leukocyte common antigen (lca). for assessment of autoimmune oophoritis, sections were immunostained with anti-lca (cd45) monoclonal antibody

Eligibility criteria:
inclusion criteria: * woman under age of 40y. * infertility. * history of oligomenorrhea or amenorrhea for 1 year or more fsh level \>20 iu/l at least 2 occasions 4-6 weeks apart (fsh level 20-40 iu/l indicates ovarian insufficiency, while level above 40 iu/l indicates complete failure). * history of thyroid dysfunction, postpartum thyroiditis and or thyroid surgery. * symptoms or signs suggestive of thyroid dysfunction or goiter. * family history of thyroid dysfunction or goiter. * presence of thyroid antibodies or other antibodies. * type 1 diabetes mellitus. * prior irradiation to head and neck exclusion criteria: * women above 40 yrs. * follicle stimulating hormone (fsh) less than 20miu/ml * women using hormonal treatement, exposed to radiation to abdomen or pelvis, chemotherapy, or ovarian surgery.
does the optic disc grading done visually by your doctor agree with optic nerve testing which is done by machines?

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to determine how well the ddls (disc damage likelihood scale) (which is a method used by the eye doctor to evaluate how healthy the optic nerve is) measures up to the standard glaucoma tests: oct (optical coherence tomography), the hrt (heidelberg retinal tomography) and the hvf (humphrey visual field).

the disc damage likelihood scale (ddls) has been shown to be a reproducible method for clinicians to evaluate the optic nerve for glaucomatous damage and is highly correlated to diagnosis of glaucoma, severity of glaucoma as evidenced by visual field loss and heidelberg retina tomography (hrt) evaluation. in comparison with the commonly used cup-disc ratio, the ddls has less inter-observer variation and captures glaucomatous aspects of the optic nerve not assessed by the cup-disc ratio. the optic nerve imagers do not have the potential to completely replace the clinical examination of the optic nerve since they do not assess many critical features such as optic nerve pallor, hemorrhages, asymmetry of disc size, edema, etc. the ddls presents the opportunity to provide a system to clinicians to increase the quality and objectivity of clinical optic nerve evaluation. the purpose of this study is to investigate the correlation of the ddls grading to oct, hrt and hvf testing of glaucomatous and normal optic nerves.

Eligibility criteria:
inclusion criteria: * vision 20/50 or better * less than 3 diopters of astigmatism * 3 diopters or less of myopia or hyperopia * pattern standard deviation on hvf less than 2.5db in normals * pattern standard deviation on hvf greater than 2.5 db in glaucoma patients exclusion criteria: * abnormalities of cornea or ocular media * significant ocular pathologies affecting visual field * history of hypotony * ocular surgery within 6 months * nystagmus * unreliable visual fields * oct signal strength scan less than 6

Keywords: primary open angle glaucoma low tension glaucoma pigmentary glaucoma exfoliative glaucoma
effect of progesterone therapy on traumatic subarachinoid haemorrhage on clinical outcome and resistive vasculer indices of middle cerebral artery transcranial doppler

Conditions: Traumatic Brain Injury

Summary: traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . delayed neuronal ischemia and rebleeding are most common and serious. progesterone can delay both .

progesterone is an neurosteroid that can help integrity of blood brain barrier . traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

Eligibility criteria:
inclusion criteria: * traumatic subarachinoid hemorrhage exclusion criteria: * history of malignency * history of cerebrovasculer stroke * morbid obese

Keywords: progesterone transcranial doppler
pharmacokinetic study of buparlisib in subjects with renal impairment.

Conditions: Renal Impairment

Summary: to characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.


Eligibility criteria:
inclusion criteria: * other than renal impairment, subjects should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria for renal impaired patients). * subjects must have a bmi between 18 kg/m2 and 34 kg/m2 and weight at least 50 kg and no more than 120 kg. * additional criteria for renal impaired subjects: - subjects must have stable renal disease without evidence of renal progressive disease defined as moderate renal impairment (egfr 30-59 ml/min/1.73m2) or severe renal impairment (egfr 15-29 ml/min/1.73m2). * additional criteria for matched healthy control subjects: - matched to at least one renal impaired subject by gender, race, age (± 10 years), and weight (± 20%). * an estimated gfr as determined by mdrd equation within normal range as determined by egfr ≥ 90 ml/min/1.73m2 exclusion criteria: * significant illness, including infections, or hospitalization within the 2 weeks prior to dosing, except for the renal impaired subjects who due to their renal disease may be affected by significant medical problems which require frequent hospitalizations. * any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study * subject has a medical history of cardiac disease and/or clinically significant ecg abnormalities within 6 months prior to screening. * subject has an active or a history within 6 months prior to screening of clinically significant hematologic, endocrinologic, pulmonary, cardiovascular, hepatic, or allergic disease, medically documented (other than clinical conditions associated with renal impairment for the renal impaired subjects only). * - additional exclusion criteria for renal impaired subjects: - severe albuminuria \> 300 mg/day. * subjects undergoing any method of dialysis. * subjects with renal impairment due to hepatic disease (hepatorenal syndrome). * subjects with clinically significant abnormal findings, not consistent with clinical disease, upon physical examination, ecg or laboratory evaluation. * use of any prescription or non-prescription medication that has the potential to interact with buparlisib within two weeks prior to dosing or during the study. * - additional criteria for matched healthy control subjects: - use of any prescription or non-prescription medication or vitamins during 14 days prior to dosing. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: renal impairment healthy volunteers clinical pharmacology study
prevention of milk-borne transmission of hiv-1c in botswana

Conditions: HIV Infection; Infant Risk for HIV Infection by MTCT

Summary: the purpose of this study is to find the most effective and safe treatment to prevent the passage of hiv from an infected mother to her baby.

1. to assess the effectiveness of the addition of a single dose of nevirapine (nvp) to zidovudine (zdv, also known as azt) as used in the botswana mother-to-child transmission (mtct) national program, in reducing transmission of hiv-1 from mother to child. to determine if maternal nvp (per hivnet 012 protocol) is necessary in the setting of maternal zdv from 34 weeks gestation through delivery and single-dose prophylactic infant nvp at birth plus zdv from birth to 4 weeks for the reduction of transmission of hiv-1 from mother to child. 2. to assess the effect of prophylactic azt given to infants during breast feeding on hiv transmission. 3. to confirm the safety and tolerance of one dose of nvp given to mothers and infants 4. to evaluate the safety and tolerance of azt given to infants for up to 6 months of age 5. to determine the association between assigned infant feeding strategy and maternal morbidity and mortality 6. to determine the rates of virologic response to nnrti-containing haart at 26 and 52 weeks after initiating treatment, among hiv+ women who previously received single dose nvp versus placebo during labour.

Eligibility criteria:
inclusion criteria: * mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to hiv-1 testing and participation; hiv-1 infected by elisa confirmed by western blot; etc.
handwriting analysis in movement disorders.

Conditions: Movement Disorders

Summary: movement disorders are a group of neurological conditions that cause problems with movement, either in the form of excessive, reduced, or slow movements. some commonly known movement disorders include parkinson disease, dystonia, ataxia, and tourette syndrome. multiple movement disorders have unique handwriting characteristics that can be measured using an inkless pen and a digitalized tablet. handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. handwriting deteriorates in patients with neurodegenerative diseases. this study aims to discern variations in the kinematics (movement patterns) involved in handwriting between individuals with movement disorders and healthy controls. participants will be invited to carry out a series of handwriting tasks. the pen motions will be captured using an inkless pen and a digitizing tablet linked to a laptop. the entire set of tasks is designed to be completed within 30 minutes. the data will then be collected, processed, and analyzed utilizing a handwriting analysis software.

background: handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. various brain structures including the cerebral cortex, basal ganglia, and cerebellum are involved in learning and performing handwriting. many neurological disorders impact these brain structures in unique ways, leading to distinct effects on handwriting. changes in handwriting performance are a prominent feature of parkinson disease (pd), ataxias, and other movement disorders. handwriting analysis can serve as a tool to distinguish and monitor the progression of movement disorders. patients suffering from pd exhibit impairments of previously learned motor skills, including handwriting. it has been demonstrated that patients in the early stages of parkinson disease exhibit variations in handwriting when compared to healthy individuals. the current research will investigate kinematics, visuospatial adaptation, and learning in different movement disorders through handwriting analysis. data collection and measurement techniques: the subject will be seated comfortably at a table with the digitalized tablet positioned to allow a natural writing position for the subject. pen movements will be recorded using a non-inking pen and wacom cintiq 16-inch digitizing tablet connected to a laptop. a practice session will be provided to each participant to familiarize them with the inkless writing pen and tablet. before each task, participants will be given instructions on how to perform the task. participants will be instructed to complete several writing exercises aimed at evaluating various aspects of their handwriting skills. each task will be repeated multiple times and the entire set of handwriting exercises will be completed within 30 minutes.

Eligibility criteria:
inclusion criteria: (1) diagnosed with a movement disorder. exclusion criteria: 1. action tremor or weakness in the dominant hand interfering with writing task. 2. unable to write or understand english
a community and tech-based approach for hypertension self-management

Conditions: Hypertension; Self-management; Technology; Community-based Participatory Research

Summary: the prevalence of hypertension among u.s. adults increased from 32% to 46% and african americans are disproportionately impacted. self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. african americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. substantial evidence has demonstrated the important role of community support in improving patients' self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered. the purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (tbi) to support self-managing hypertension (called coachman) to improve bp control.

coachman targets barriers to hypertension knowledge, medication adherence, problem solving skills, patient-provider communication, and social support in an effort to improve blood pressure control. the investigators will conduct a two-arm randomized control trial (rct) using a community participatory research approach and mixed methods to evaluate the efficacy of tbi intervention with community support (coachman) compared to enhance usual care (ecu) among 60 african americans with uncontrolled hypertension. the investigators aim to: 1. identify key content, design, and resources from a community of stakeholders, including determining facilitators and barriers of hypertension self-management among african americans that will inform the development of coachman using a mixed methods approach methods. 2. evaluate the feasibility and acceptability of coachman to improve bp control. 3. compare the difference in bp control between technology-based intervention (tbi) and enhanced usual care (euc).

Eligibility criteria:
inclusion criteria: * self-identifying as african american * age 30 years or older * diagnosed with hypertension, with a blood pressure \>140/80 mmhg * prescribed at least one antihypertensive medication * able to read and understand english * own a smartphone exclusion criteria: * history of cognitive impairment * currently using a medication management app