Kornimate/medical-research-clean huggingface dataset:
temozolomide in treating patients with brain metastases

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients who have brain metastases.

objectives: * determine the activity of temozolomide in patients with brain metastases. * determine the toxicity of this treatment in these patients. outline: patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other). patients receive oral temozolomide daily on days 1-7 and 15-21. treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 180 patients (30 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * metastatic lesions to the brain * must not require immediate radiotherapy * if received prior radiotherapy, must have progressive disease * evaluable disease by ct scan or mri * neurologically stable patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * more than 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * sgot or sgpt less than 2.5 times uln * alkaline phosphatase less than 2 times uln renal: * blood urea nitrogen less than 1.5 times uln * creatinine less than 1.5 times uln other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other concurrent nonmalignant systemic disease * no acute infection requiring treatment with iv antibiotics * hiv negative * no frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow) prior concurrent therapy: biologic therapy: * no concurrent hematopoietic growth factors, including epoetin alfa * no other concurrent biologic therapy chemotherapy: * at least 4 weeks since prior chemotherapy, unless evidence of disease progression * no other concurrent chemotherapy endocrine therapy: * concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression * no concurrent radiotherapy surgery: * at least 3 weeks since prior surgery, unless evidence of disease progression, and recovered other: * no other concurrent investigational drugs

Keywords: adult tumors metastatic to brain
a study of participants in australia who have non-small cell lung cancer being treated with nivolumab

Conditions: Non-Small Cell Lung Cancer

Summary: this study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced nsclc who have been treated with nivolumab


Eligibility criteria:
inclusion criteria * adult male or female (≥18 years of age) patients with nsclc * treated with nivolumab on the australian pap * initiated nivolumab between may 2015 and august 2017 * attending clinician agreeable to provide patient data * local institutional ethics requirements satisfied exclusion criteria: * insufficient data available other protocol defined inclusion/exclusion criteria could apply
spinal and supraspinal control in chronic ankle instability

Conditions: Ankle Injuries; Ankle Sprains

Summary: ankle sprains are common sports injuries that often lead to chronic ankle instability (cai). patients with cai experience deficits in neuromuscular control (nmc), including proprioception and strength. it is believed that damage to the ankle's ligament mechanoreceptors and the peroneal nerve after the initial ankle sprain can cause alterations in nmc, resulting in postural control and dynamic joint stability dysfunction. inflammation related to recurrent ankle sprains may also contribute to neuromuscular impairments. evidence suggests that bilateral postural control deficits occur after an ankle sprain, suggesting alterations in the central nervous system (cns). rehabilitation for cai has been shown to lead to bilateral improvements in nmc, potentially due to neural alterations at both the spinal and supraspinal levels. cross-education, which refers to the muscular crossed effect of unilateral training, has also been proposed as a mechanism for improving contralateral strength in neurologically healthy individuals. while the exact mechanisms underlying cross-education are not yet fully understood, evidence suggests that it involves neural adaptations at both spinal and supraspinal levels. this study aims to investigate the cross-education effect of a 6-week, unilateral balance training on corticomotor excitability, motor neuron pool excitability, and static and dynamic balance in athletes with chronic ankle instability.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * being an athlete between the ages of 18-25, * being a player in a field team sport such as basketball, volleyball, and handball, * having a history of at least 2 significant grade ii las diagnosed by a physician, * related inflammatory symptoms, "giving away" sensation, obtaining a score ≤25 from the cumberland ankle instability tool (cait), * a score \<90% for the activities of daily living subscale and \<80% for the sport subscale from the foot and ankle ability measure, * recurrent episodes of las of the injured ankle which occurred within at least 12 months. exclusion criteria: * acute injury of lower extremity musculoskeletal structures in the last three months, * orthopedic surgery in any of the lower extremities, * bilateral ankle instability, * vestibular or balance disorder

Keywords: ankle, joint instability, cross-education, rehabilitation
osi-774 and bevacizumab in the treatment of patients with metastatic renal cell carcinoma

Conditions: Kidney Cancer

Summary: in this phase ii trial, we plan to evaluate the combination of tarceva and avastin in the treatment of patients with metastatic renal cell carcinoma. this trial will be one of the first phase ii trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on cancer biology (vhl/hif/vegf/egfr).

upon determination of eligibility, all patients will receive: tarceva + avastin

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic or unresectable clear cell kidney cancer confirmed by biopsy * previous nephrectomy * maximum of 1 previous regimen for metastatic disease * ability to perform activities of daily living with minimal assistance * measurable disease * adequate bone marrow, liver and kidney function * give written informed consent prior to study entry exclusion criteria: you cannot participate in this study if any of the following apply to you: * age \< 18 years * treatment with more than one previous regimen for metastatic disease * clinically significant cardiovascular disease * active brain metastases * history of cns disease * clinical history of coughing or vomiting blood. * history of thromboembolic disease. * peg or g-tube are ineligible. * current use of full dose anticoagulants or thrombolytic agents * chronic daily treatment with aspirin or nsaids * any clinical evidence or history of a bleeding or clotting disorder please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Keywords: kidney cancer
breathing exercises and auricular vagus nerve stimulation

Conditions: Breathing Exercises; Auricular Vagus Nerve Stimulation; Autonomic Nervous System

Summary: introduction: vagal modulation is achieved directly by transcutaneous auricular vagus nerve stimulation, whereas breathing exercises stimulate arterial baroreceptors. in this study, we aimed to compare these two methods, which have similar effects. methods: 88 healthy participants aged 18-35 were randomly divided into breathing exercises (group be) and vagus stimulation (group vns). thoracic expansion exercise was performed in the be group. in the vns group, biphasic electrical stimulation was applied to both ears with a pulse width of 300 microseconds, frequency of 10 hz, and 20 minutes. pulmonary function tests were measured on the first and last day. heart rate, systolic and diastolic blood pressure, rmssd, pnn50, lf/hf, lf power, and hf power values were measured before and after each of the ten sessions for both groups.


Eligibility criteria:
inclusion criteria: * healthy individuals between the ages of 18 and 35, * without orthopedic disability, * without any chronic disease and regular medication use, * who had not smoked for the last year, * who had no problems in reading, writing, or comprehension were included in our study. exclusion criteria: * active or chronic respiratory diseases and communication problems because they may adversely affect pulmonary function testing

Keywords: breathing exercises autonomic nervous system pulse rate variability respiratory functions auricular vagus nerve stimulation
anti-viral action against type 1 diabetes autoimmunity

Conditions: Diabetes Mellitus, Type 1

Summary: the study gppad-05 avant1a is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive covid-19 vaccination (comirnaty® 3 μg omicron xbb.1.5 or new variant comirnaty vaccines ) or placebo from age 6 months. the study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes. the primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against covid-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. secondary objectives are: 1. to determine whether vaccination against covid-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood. 2. to determine whether vaccination against covid-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and 3. to determine whether vaccination against covid-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood. further exploratory objectives are described in the study protocol. study participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (nct03316261). eligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit). randomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. consent will be obtained by the custodial parents prior to enrollment.


Eligibility criteria:
inclusion criteria: 1. ages between 3.00 and 4.00 months at the time of enrollment. 2. a high genetic risk (\>10%) to develop islet autoantibodies by age 6 years as determined by a hla dr/dq genotype, polygenic risk score and first-degree family history of type 1 diabetes status. 3. written informed consent signed by the custodial parent(s). exclusion criteria: 1. previous hypersensitivity to the excipients of the vaccine. 2. any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. these include immune deficiencies, and conditions or treatments that lead to immune suppression. 3. likely poor compliance due to expected change in residency. 4. diagnosis of diabetes prior to recruitment or randomisation 5. current use of any other investigational drug

Keywords: type 1 diabetes t1d diabetes mellitus autoantigen prevention at risk for developing type 1 diabetes juvenile diabetes autoimmune diabetes corona covid-19 viral infection viral infection surveillance immune response metabolism
sacral neuromodulation and pudendal somatic afferents

Conditions: Overactive Bladder, Non Obstructive Urinary Retention

Summary: sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.a tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is. this study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.


Eligibility criteria:
inclusion criteria: * overactive bladder * non-obstructive urinary retention exclusion criteria: * neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)
comparison of outcome of microneedling with autologous prp vs microneedling with topical insulin in treatment of post acne atrophic scars.

Conditions: ATROPHIC ACNE SCARS

Summary: microneedling with topical insulin is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. the skin responds to fine punctures with the release of growth factors. 8 it is a safe procedure that can be performed in the office without complications, with a good cost-benefit because it is economically viable without any effect on patient's daily activities. 9


Eligibility criteria:
inclusion criteria: * postacne atrophic scars ≥ 2 on goodman and baron's acne scar-grading system * either gender. * age 20-50 years. exclusion criteria: * lactation and pregnancy * skin cancers and infection * photosensitivity like sle ,xp * use of retinoids in last 6 months.
association between fatigue and balance in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the relationship between fatigue and balance was established. fatigue was correlated with 8 parameters of balance scales. moreover, there was a strong correlation between the level of fatigue from one side and depression, quality of life and disease severity from the other side.fatigue seems to be the main problem in patients with ms which may influence other signs and symptoms such as balance.

electromagnetic field significantly reduced fatigue level in patients with ms.this effect reflected significantly on other symptoms such as balance, depression, disease severity and the quality of life in those patients. virtual reality program significantly improving balance and balance perception .virtual reality program also improved quality of life by improving general health, physical function and decreasing physical limitation significantly. however, virtual reality programs did not improve fatigue.

Eligibility criteria:
inclusion criteria: * relapsing remitting type of ms. * age between 20-50 years. * ambulatory with or without an device. * complaining of fatigue, have a score of 4/10 or more on the fatigue visual analogue scale in last four weeks exclusion criteria: * an acute episode of ms within the last 30 days. * pregnancy at any stage. * severely blurred vision. * a pacemaker. * epilepsy of any type. * recent organ transplant. * cardiac arrhythmia. * large aneurysm. * heavy psychosis. * otitis media in last 2 weeks.

Keywords: multiple sclerosis fatigue balance
study evaluating the safety of hcv-796 in subjects with liver disease and in healthy adults

Conditions: Hepatitis C; Hepatic Insufficiency

Summary: the purpose of this study is to assess the pharmacokinetics (pk) of hcv-796 in subjects with chronic hepatic impairment and in matched healthy adults.


Eligibility criteria:
inclusion criteria: * men and women of non-childbearing potential. * hepatic impairment subjects: child-pugh class a, b, or c according to the c-p classification based on history, physical examination, and laboratory test results. * healthy volunteers: healthy as determined by the investigator. exclusion criteria: * history of alcoholism within 1 year. * hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function. * healthy volunteers: positive serologic findings for hepatitis b surface antigen (hbsag) and/or hepatitis c virus (hcv) antibodies.

Keywords: hepatitis c hepatic impairment healthy volunteer phase 1 hepacivirus
association between non-alcoholic fatty liver disease and iron status

Conditions: NAFLD - Non Alcoholic Fatty Liver Disease

Summary: the investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease. the aim of the study is to show the association between the severity of non-alcoholic fatty liver disease to low iron status.

patients that will pass a ct scan that includes the abdomen will be asked to participate at our study. these patients will be divided into two groups - with and w/o fatty liver. the severity of fatty liver will be determined using the ct scan (as well as other parameters, such as the size of subcutaneous fat layer). within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a bmi calculation and a blood pressure measurements). in the blood test we will examine liver functions, iron status etc. this is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

Eligibility criteria:
inclusion criteria: * age\>18 * bmi\>25 exclusion criteria: * pregnancy * unable to sign an informed consent (legally) * known solid/hematological malignancy * hemoglobinopathy or myelodysplastic disease (not including g6pd deficiency) * active or carrier of viral hepatitis * treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, haart, steroid treatment \> 3 months) * consumption of \> 120g ethanol per week * primary liver disease (eg. glycogen storage disease) * crp\>20 * acute intoxication * surgery in previous 7 days
translation, validity, and reliability of the foot posture index (fpi-6) - turkish version

Conditions: Foot Deformities; Pes Planus; Hallux Valgus; Metatarsalgia; Feet Pes Planus (Flatfoot)

Summary: individuals with foot-ankle problems (plantar fasciitis, metarsalgia, pes planus, pes planovalgus/varus) will be included in the study. permission was obtained from the research group that developed the scale to use the original foot posture index-6 (fpi-6). cross-cultural adaptation of the fpi-6 will be made in line with the guidelines published by ruberto and beaton. first of all, the fpi-6 will be translated into turkish by two translators whose native language is turkish and who can speak english at an advanced level. translations will be compared and discussed, and a turkish version will be obtained with the equivalents that best represent each item in the texts. secondly, this retranslated text will be independently translated back into english by two native english translators. in the third stage, two texts written in english will be synthesized by the authors, thus reaching a consensus on a single translation. finally, the inconsistent parts of the text will be checked by a multidisciplinary team consisting of two native english-speaking translators, members of the english language and literature department, authors who developed the scale, and physiotherapists. two independent physiotherapists will evaluate the participants' foot posture indexes by fpi-6 for inter-rater reliability. in addition, patients' quality of life, foot functions, hindfoot profiles will be evaluated. for the calculation of validity between measurements, rater-1 will apply the fpi-6 again to the same participants after 15 days for intra-rater reliability. patients' functional independence, activities of daily living, and quality of life will also be evaluated for criterion validity. american orthopedic foot and ankle society-aofas, sf-36 and foot function index questionnaires will be applied for the validity of fpi-6.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having foot-ankle problems (plantar fasciitis, metatarsalgia, pes planus, pes planovalgus/varus, hallux valgus, pes cavus, pain) exclusion criteria: * having undergone any lower extremity surgery in the last two years, * patients with congenital foot deformity and neurological problems, * individuals with lower or upper extremity pathology or a cognitive problem that may prevent or limit the application of the test protocol
temperature on evaporative dry eye

Conditions: Dry Eye

Summary: ocular surface temperature of a normal person is around 34.6 degree centigrade. after instilling the eye drop, depending on the temperature of the eye drop and the ocular surface, the ocular surface temperature will temporally increase or decrease sightly. warm feeling will make blood vessels dilated and more blood will pass through to bring more blood flow out of our body to the heated area of the body and makes cells more permeable. therefore, heating the ocular surface with heated eye mask after instilling artificial tears has the possibility to improve drug permeability on the ocular surface.

evaporative dry eye (ede) is common and can lead to ocular pain, decreased visual quality, and reduced quality of life. 3% diquafosol (dqs) ophthalmic solution and heated eye mask (hem) have been found to be beneficial in reducing signs and symptoms of dry eye. warm compress therapy temperature of 40 °c to 45 °c have been typically advocated to melt the meibium causing obstruction at the orifices of the meibomian gland, eventually allowing increased lipid layer of the tear film. while in impact of heat on the ocular surface (os) has not been extensively studied. controlled and precise application of heat has the ability to create a cascade of events in the skin and thus aids in facilitating a faster movement of molecules into and across the skin. possible mechanisms of enhancing drug permeation include on the ocular surface could be: (mechanisms may operate individually or concurrently): * increase in drug diffusivity in the vehicle and/or in the ocular surface * increase in partitioning and diffusion * alteration in the lipid structure * increased local blood flow therefore, the purpose of this rct is to assess the impact of instilling 3% dqs ophthalmic solution follow by hem raising the os temperature by 40 degrees centigrade for 10 minutes.

Eligibility criteria:
inclusion criteria: * age ≥18 years * the presence of at most one symptom including burning, foreign body sensation, itching or eye fatigue for 3 months * osdi score ≥ 13 and tbut \<5 s or nibut \< 10s * able and willing to comply with the treatment/follow-up schedule exclusion criteria: * a recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications * eyelids or intraocular tumors that should not put pressure * active allergy or infection or inflammatory disease that may have prevented the subjects from completing the study at the ocular surface * any structural change in lacrimal passage * glaucoma * diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of ocular surface * use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, antidepressive, and antihistamine medications within 3 months

Keywords: dry eye heated eye mask diquafosol tear breakup time ocular surface disease index