Kornimate/medical-research-clean huggingface dataset:
safety of everolimus in combination therapy, in patients with her2-overexpressing metastatic breast cancer

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: this study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with her-2 overexpressing metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female or male patients ≥18 years with who performance status ≤ 1 * her-2 overexpressing metastatic breast cancer cells confirmed by histology * progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy * patients neurologically stable with adequate bone marrow, liver and renal function exclusion criteria: * patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start * patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start * patients who have previously received vinorelbine or mtor inhibitors other protocol-defined inclusion/exclusion criteria may apply

Keywords: her2-overexpressing metastatic breast cancer breast cancer cancer of the breast human mammary carcinoma her-2 metastatic everolimus trastuzumab vinorelbine
the mcce vs egd trial

Conditions: Anaemia; Acute Coronary Syndrome

Summary: anaemia is common in patients with acute coronary syndrome (acs) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (mace). esophageal-gastro-duodenoscopy (egd) is commonly used as an initial investigation for anaemia but is often non-diagnostic. magnetically controlled capsule endoscopy (mcce) being less invasive and with comparable diagnostic accuracy as egd, might be used as an alternative initial investigation for anaemia in patients with acs.

anaemia is common in patients with acute coronary syndrome (acs) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (mace). esophageal-gastro-duodenoscopy (egd) is commonly used as an initial investigation for anaemia but is often non-diagnostic. magnetically controlled capsule endoscopy (mcce) being less invasive and with comparable diagnostic accuracy as egd, might be used as an alternative initial investigation for anaemia in patients with acs.

Eligibility criteria:
inclusion criteria: subjects are patients older than 18 years old with: 1. the diagnosis of acs as defined by symptoms of chest pain or shortness-of-breath, abnormal electrocardiogram and positive enzyme, requiring coronary intervention 2. new-onset anaemia as defined by hb\<11 g/dl on admission blood taking exclusion criteria: 1. history of active haematological disease including hemoglobinopathies such as thalassemia, myelodysplastic syndromes, haematological malignancy, aplastic anaemia, or autoimmune haemolytic anaemia. 2. patients with known active gastrointestinal malignancy. 3. contraindications for ce: suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required; history of laparotomy, gastric or bowel surgery; presence of metallic implants that is not mri conditional. 4. contraindications for egd: possible gastrointestinal perforation, medically unstable patients, patient with known pharyngeal diverticulum, and patients with recent head and neck trauma. 5. inability to take 1-month dapt such as non-deferrable surgery within 1 months, severe allergy or hypersensitivity reaction to aspirin or p2y12 inhibitors, or patients in whom 1 months dapt is not indicated. 6. patients whose life-expectancy is less than 6 months. 7. patients who are pregnant or lactating. 8. patients who are unable to give informed consent. 9. patients who are in active heart failure or fluid-overload state. 10. patients who have chronic renal failure as defined by estimated glomerular filtration rate \<15 ml/min/1.73m2.

Keywords: capsule endoscopy esophago-gastro-duodenoscopy
the influence of the manipulation of the sacroiliac joint on low back pain

Conditions: Low Back Pain; Sacroiliac Disorder

Summary: the primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint

one of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: pharmacological treatments like nsaids have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective. a total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the physiotherapy unit of gévora health center (badajoz, spain) voluntarily entered the study

Eligibility criteria:
inclusion criteria: * dysfunction or sacroiliac joint hypomobility (si) * having stopped taking anti-inflammatory medicines or analgesics three days before the study began exclusion criteria: * destructive injuries of the spine and pelvis * fractures * lumbar surgery * sacroiliac instability * spondylolisthesis * pregnancy in progress * cauda equina syndrome * abdominal aneurysm * infection * inflammatory arthritis * tumors * osteoporosis

Keywords: sacroiliac joint low back pain osteopathic manipulation
the impact of communication with healthcare providers via wechat on survival outcomes for lung cancer patietns

Conditions: Lung Cancer

Summary: the use of smartphone-based wechat applications offers significant advantages in cancer patient education, rehabilitation monitoring, and postoperative symptom management. through the wechat platform, patients can access health education materials, engage in online consultations, and interact with doctors and other patients at any time. this ongoing education and psychological support help alleviate patient anxiety and improve their quality of life. this study aims to conduct a prospective observational study in our hospital to explore the impact of wechat communication on the prognosis of patients with different histological types and stages of lung cancer.


Eligibility criteria:
inclusion criteria: * (1) lung cancer patients receiving treatment at shanghai pulmonary hospital (2) ecog performance status of 0-2 (3) no other serious internal medical conditions (such as severe heart failure, hypertensive crisis, diabetic ketoacidosis, severe liver or kidney impairment, etc.) (4) no history of other malignant tumors in the past 5 years, and no detection of other tumor history during follow-up after lung cancer diagnosis (5) relevant pathological results exclusion criteria: * (1) patients refused enrollment in this study; （2）patients refused follow-up.
transcranial magnetic stimulation effects on nicotine craving

Conditions: Nicotine Dependence

Summary: the proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of repetitive transcranial magnetic stimulation (rtms) on nicotine craving and cue-reactivity among adult regular smokers.

this pilot protocol proposes to test and further develop tms for the purpose of studying brain function in nicotine users. specific primary aims include: aim # 1. to test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of tms in cigarette smokers. aim # 2. given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rtms will impact measures of craving and the reinforcing effects of nicotine. design: the study was a randomized, blind, sham-controlled crossover study in which participants will involve two study visits. participants will have an initial assessment about tobacco use habits and craving patterns. participant will look at images related to and not related to cigarette smoking. participants will receive two different types of brain stimulation with repetitive tms (10 hz): sham rtms and active rtms over prefrontal cortex. craving assessments will be performed before and after each stimulus experiment. participants will be measured cortical excitability with tms before and after each stimulus experiment.

Eligibility criteria:
inclusion criteria: * right handed males and females, between the ages of 18 and 50 * daily smokers who smoke at least 10 cigarettes per day for at least past 1 year * mentally capable of reading, writing, giving consent, following instructions exclusion criteria: * history of seizures * taking medications that lower seizure threshold * implanted metal devices (e.g., pacemakers, metal plates, wires) * pregnant * history of brain surgery or history of loss of consciousness \>15 minutes * any unstable major axis i psychiatric disorder in the past month (e.g. psychotic disorders) * current substance use disorders other than nicotine and caffeine use, in the past 30 days * any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring

Keywords: nicotine craving smoking tms prefrontal cortex
prophylactic noradrenaline infusion and its impact on post-induction hypotension

Conditions: Post Induction Hypotension; Sepsis

Summary: researchers aim to evaluate the influence of prophylactic noradrenaline infusion on post-induction hypotension

if post-induction hypotension is not addressed promptly, it can lead to severe complications such as reduced blood flow, acute kidney damage, and myocardial ischemia. as a result, early detection and proactive intervention are crucial. researchers of the current study decided to investigate impact of noradrenaline administered as a prophylaxis on post induction hypotension

Eligibility criteria:
inclusion criteria: * adult patients with sepsis undergoing source control surgery. exclusion criteria: * patient refusal * patient with cardiac pathology ( ischemic heart disease or heart failure) * preoperative hemodynamic instability (defined as map \< 65 mmhg) * rapid sequence induction

Keywords: hypotension noradrenaline sepsis
diagnostic accuracy study of indocyanine green for perfusion assessment

Conditions: Hypoparathyroidism

Summary: background near-infrared fluorescence guided surgery with indocyanine green (icg) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. icg can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. icg was already approved in 1956 for clinical use of tissue perfusion. however, until now there is still no (parathyroid) universal standard imaging protocol for icg-guided fluorescent surgery including quantitative evaluation. main research question to develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with icg including quantitative evaluation of the fluorescent signal. • design (including population, confounders/outcomes) this will be a proof-of-concept, prospective cohort study of patients undergoing an icg-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. the main study endpoint is quantification of the fluorescent signal of icg stratified by the occurrence of hypoparathyroidism. hypoparathyroidism will be defined as a decrease in pth of \&gt;70% at the first postoperative day. furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism. secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, pth, albumin) and postoperative medication use. expected results we expect that the results of this study will lead to the development of a universal standard imaging protocol for icg-guided fluorescent total thyroidectomy.


Eligibility criteria:
inclusion criteria: 1. age \&gt;18 years 2. patients undergoing icg-guided total thyroidectomy as surgical procedure for thyroid cancer, graves' disease or goiter 3. patients are eligible for surgery 4. patients are mentally competent 5. written informed consent exclusion criteria: 1. patients with known allergy for icg or iodinated contrast 2. pregnant or lactating women 3. patients with previous neck surgery 4. patients with dialysis dependent renal failure and kidney transplant
a pilot study of the effects of isotretinoin on cognition, learning and memory

Conditions: Acne Vulgaris

Summary: this prospective study tested the effects of isotretinoin in a cohort of patients receiving standard therapy for acne vulgaris. subjects completed questionnaires and standardised computer based cognitive testing using cantab to test for cognitive effects particularly on learning and memory. test were conducted before starting isotretinoin, after 3 months and again a month after finishing therapy. this was carried out as a pilot study to 1. test the hypothesis that oral isotretinoin, over its 4-month treatment time, will result in a decline in learning and memory as measured using the cantab series of test. 2. generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group 3. test of cantab, questionnaires and data collection forms 4. select most appropriate outcome measures 5. identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies it was not considered to randomise subjects to placebo.


Eligibility criteria:
inclusion criteria: 1. adult subjects age 16 and over with acne vulgaris 2. cases should be candidates for isotretinoin therapy should have severe acne not responding to treatment and at risk of scarring and have discussed the risks, pregnancy prevention program and benefits of this treatment according to normal clinical practise exclusion criteria: 1. subjects already on treatment with isotretinoin 2. subjects with below normal intelligence who would not understand the cantab psychological tests 3. subjects with neurological disease e.g. epilepsy or pre-existing mental health problems 4. pregnant females or females not taking preventive precautions 5. subjects on sedative or psycho-active medications that could interfere with the outcomes tested

Keywords: isotretinoin hippocampus memory learning cantab
mri and cardio-pulmonary exercise testing in evaluating exercise intolerance in patients with stage i-iii breast cancer after chemotherapy treatment

Conditions: Healthy Subject; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this pilot research trial studies magnetic resonance imaging (mri) and cardio (heart)-pulmonary (lung) exercise testing in evaluating exercise intolerance in patients with stage i-iii breast cancer after treatment with chemotherapy drugs called anthracyclines. anthracyclines are related with heart problems, cardiac abnormalities, bone and muscle dysfunction. patients with breast cancer who are exposed to anthracycline drugs may also experience progressive fatigue and exercise intolerance which may limit daily activities and is an important barrier for patients returning to work. using mri and cardio-pulmonary exercise testing (cpet) may help doctors understand the causes of fatigue and exercise intolerance in patients receiving anthracycline chemotherapy and this may also allow doctors to plan better treatments to protect patients' heart, cardiovascular system, bone and muscle function.

primary objectives: i. to determine the feasibility of performing upright treadmill cardio-pulmonary exercise stress testing utilizing magnetic resonance imaging. ii. to determine the reproducibility of measures of peak oxygen uptake (v02) and cardiac output as well as arterio-venous oxygen difference (a-v02) difference in survivors of breast cancer treatment and control participants. outline: patients undergo cpet using a one-way breathing mask in 2 separate days 1-2 weeks apart. patients also undergo mri before and within 60 seconds after exercising.

Eligibility criteria:
inclusion criteria: * women with stage i-iii breast cancer who began their cancer treatment 1-2 years prior to this study and have received anthracycline based chemotherapy * women matched to age with our 16 post-cancer treatment participants exclusion criteria: * those with contraindications for mri such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices * those with contraindications for exercise tolerance test (ett) testing, including unstable angina or inability to exercise on a treadmill or stationary cycle * those who are pregnant, claustrophobic, or unable to provide informed consent
assessment of stability of mail-in capillary hemoglobin a1c test kit

Conditions: Diabetes

Summary: the purpose of this study is to determine the stability of capillary hba1c blood samples collected by the participant with this kit and mailed to the laboratory at children's mercy hospital.

participants are given home lab kit for obtaining hba1c by capillary blood and shipping it to children's mercy hospital and clinics. they will mail in sample before their next visit and this result will be compared to the hba1c performed during this visit.

Eligibility criteria:
inclusion criteria: * male or female diabetic patients ages 1-17 years who have an a1c test drawn within 24 hours * participants receiving medical care in the endocrine clinic at children's mercy hospital exclusion criteria: * not meeting above inclusion criteria

Keywords: diabetes
daily sodium intake in anuric hemodialysis patients and interdialytic weight gain

Conditions: End Stage Kidney Disease

Summary: this study will evaluate the efficiency of dietary intervention on intradialytic weight gain. uniric hemodialysis patients without serious dietary complications, who accumulate above 2.5 kg (or above 4%) of their dry weight, will undergo a series of dietary consultations for sodium restriction. one month after the intervention, their intradialytic weight accumulation will be measured.

inter dialytic weight gain (idwg) ascribed to fluid retention is one of the major clinical problem that patients in hemodialysis need to cope with between 2 subsequent hemodialysis especially in patients with no residual renal function. fluid retention is associated with morbid conditions such as lower-extremity edema, ascites, pulmonary vascular congestion or edema, hypertension, and worsening heart failure. gain weight above 2 kg between 2 subsequent hemodialysis found to be in higher risk of all-cause mortality and cardiovascular death .lowering daily sodium intake found to mitigate fluid retention ,however there are only a few researches that check it. 2idwg also associated with poorer quality of life. dietary sodium restriction recommendation since the beginning of hemodialysis are based on association of this restriction with balance of hypertension and fluid retention. sodium intake recommended for patients in hemodialysis is limited to 2 grams a day. nevertheless, there are only a few studies that examine the efficiency of this restriction because of the complexity of measurement of sodium intake. one recently published study which used a 24-h recall to measure sodium intake, found a direct correlation between idgw and mortality form any reason. in spite of this complexity, idwg has been found to be in a direct relation with patients' nutrition status. one of sodium-related issues is malnutrition. malnutrition in dialysis is a risk factor for patients' morbidity and mortality. higher sodium intake is associated with higher calorie and protein intake, while adherence to restriction of sodium intake is poor in hemodialysis. this is a reason for high importance to study effects of sodium restriction in people with more than 2.5 kg (or 4% of dry body weight) idwg while following up their nutritional status

Eligibility criteria:
inclusion criteria: 1. adults \>18 years providing signed informed consent. 2. any patient more than 3 months in hemodialysis who reach his assigned dry weight. 3. intradialytic weight gain of more than 2.5 liters or 4% of dry body weight in two mid-week sessions. 4. residual renal function of less than 200 ml per 24 hr. 5. expected to stay on hemodialysis for at least 6 month. exclusion criteria: 1. malnutrition as assessed by sga: score c. 2. dementia 3. active malignancy 4. active infection
integrating buprenorphine into hiv treatment

Conditions: Opiate Dependence; HIV Infections

Summary: we hypothesize that integrating drug treatment into hiv treatment will improve hiv outcomes as well as drug treatment outcomes in heroin users. this study will test this hypothesis by randomizing patients to two groups. the first group will receive hiv treatment and buprenorphine treatment contemporaneously at their hiv clinic. the second group will receive hiv treatment at their hiv clinic, and go to another facility to receive buprenorphine treatment services. we will look at hiv outcomes such as cd4 counts, hiv viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.

this study will test the hypothesis that integrating buprenorphine within the context of primary care hiv treatment will improve outcomes for hiv-infected heroin users vs providing buprenorphine services at a separate, off-site facility. as a means of engagement, we will offer the oasis education group each week at each facility. for those randomized to integrated care, subjects will attend one education session weekly at the time of their hiv clinic. during these sessions, subjects will receive contemporaneous hiv clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) for those randomized to separate care, subjects will attend hiv clinic appointments monthly, and will attend weekly education sessions at the oasis facility. during these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management. we will measure outcomes by reporting attendance, cd4 counts, hiv viral loads, urine toxicology testing on at least a quarterly basis. we will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.

Eligibility criteria:
inclusion criteria: * hiv+ as verified by lab report * dsm-iv diagnosis of opioid dependence * speaks/understands english * age 18 years or older exclusion criteria: * lft's (transaminase) \>5x uln * dsv-iv criteria for benzodiazepine abuse or dependence within the last month * dsm-iv criteria for alcohol dependence within the past 6 months * actively suicidal * methadone dose exceeds level allowing safe transition to buprenorphine * pregnant women and women trying to become pregnant * unable to provide informed consent * clinical judgement that patient is inappropriate

Keywords: heroin hiv buprenorphine integration drug treatment