Kornimate/medical-research-clean huggingface dataset:
smoking, stress, hiv and mobile technology

Conditions: Cigarette Smoking

Summary: the present investigation aims to address disparities in cigarette use outcomes among black/african american adults with hiv. the specific aims of this study are: (1) to modify a recently developed, culturally adapted, mobile application for black smokers by integrating information specifically relevant to black persons with hiv/aids. (2) to conduct a randomized clinical trial for anxiety-sensitivity reduction and cigarette cessation among black smokers with hiv.

the current trial aims to refine and conduct a comprehensive cultural and hiv-sensitive adaptation of an initially tested, novel mobile intervention (masp+) targeting anxiety sensitivity (as) among black/african american (daily) cigarette users with hiv/aids. the masp+ app prompts users remotely throughout the day to assess mood symptoms, cigarette cravings or nicotine withdrawal symptoms, and general mental health. when respondents indicate they are struggling with cigarette urges or cravings, or if they are experiencing heightened levels of stress or anxiety, the app selects and delivers a tailored message from a library of messages and videos. the masp+ app has the potential to deliver highly effective and accessible treatment to a highly underserved subpopulation within the black community considered to be at exceptionally high risk of smoking problems (social, psychological, physical) and smoking relapse.

Eligibility criteria:
inclusion criteria: * hiv-infection (via self-report and picture of medication, lab tests, or diagnosis) * 18+ years of age * self-identify as black / african american * daily smoking (minimum of 10 cigarettes per day on average for at least 2 years) * motivated to quit smoking (≥ 5 on a 10-point scale) * willingness to discontinue cigarette use two weeks after baseline visit. * english literacy (score of 4 or greater on realm-sf) * moderate to high anxiety sensitivity (score of 5 or greater on ssasi) * provide a current picture of their cigarette package to verify smoking status * willing to complete all study surveys/assessments * agree to use nicotine replacement medications (nrt; nicotine patch and lozenges) * agree to attempt to quit smoking two weeks after completion of the baseline survey and receipt of study materials exclusion criteria: * actively receiving (ongoing) pharmacotherapy or psychotherapy directly focused on the treatment of smoking cessation, and/or substance use, not provided by the study * non-fluent/limited english proficiency * self-reported pregnancy or intentions to become pregnant in near future * legal status that would interfere with participation * being non-black * cognitive impairment (assessed via the 6-item cognitive impairment test)

Keywords: hiv minority stress mhealth smoking cessation anxiety sensitivity
hyperalgesia and nmda receptor antagonist

Conditions: Pain

Summary: nmda receptor is administered and postoperative remote hyperalgesia is investigated.

nmda receptor is adminstered and postoperative tertiary hyperalgesia is investigated. qst and pain measures for remote hyperalgesia are compared between control and magnesium or ketamine group.

Eligibility criteria:
inclusion criteria: * asa1-2 exclusion criteria: * contraindication to the study drugs

Keywords: pain
six vs 12 months of trastuzumab with docetaxel following fec as adjuvant treatment in n+ breast cancer

Conditions: Breast Cancer

Summary: this trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following fe75c as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing her2

anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. in at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. in two large randomized studies the dose dense administration with g-csf support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. in one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. trastuzumab (anti-her2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing her2

Eligibility criteria:
inclusion criteria: * women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma * her2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or fish/cish positivity. a score of 2+ by immunohistochemistry is acceptable only if fish/cish positive * within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed. * tumor involvement of at least one axillary lymph node (n0 with her2/c-neu over expression are also eligible) * absence of any clinical or radiological evidence of local or metastatic disease * premenopausal or postmenopausal women aged 18-75 years old * adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3) * adequate liver (bilirubin \<1.0 times upper limit of normal and sgot/sgpt \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl) * adequate cardiac function (lvef\>50%). normal electrocardiogram and absence of significant heart disease * written informed consent exclusion criteria: * positive pregnancy test. * psychiatric illness or social situation that would preclude study compliance. * other concurrent uncontrolled illness. * prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents. * previous history of other invasive malignancy other than non-melanomatous skin cancer.

Keywords: early breast cancer axillary node positive her2 overexpression adjuvant chemotherapy dose dense docetaxel trastuzumab fec
early and systematic shoulder rehabilitation following cervical lymph node dissection

Conditions: Rehabilitation

Summary: a prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.

pre-inclusion: information, collection of consent, collection of antecedents and biometric data, clinical examination (goniometric measurement and visual analogic scale of pain), collection of dash, eortc qlq-c30 and h\&n35 questionnaires. surgical intervention (j0) and randomization into 2 groups: group 1 - systematic early rehabilitation group 2 - without systematic rehabilitation m3, m6, m12: collection of complications, adjuvant treatments, number of physiotherapy sessions performed, clinical examination (goniometric measurement and visual analogic scale of pain), collection of dash, eortc qlq- c30 and h\&n35 questionnaires.

Eligibility criteria:
inclusion criteria: * proficiency in the oral and written french language * unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve * karnofsky index ≥ 80% * age ≥ 18 years exclusion criteria: * cognitive disorders * predictable difficulties in compliance with treatment and/or follow-up * pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer * comorbidity preventing rehabilitation of the shoulder * time to start rehabilitation after 6 weeks postoperatively * pregnant women * minors * majors under guardianship * refusal to participate in the study

Keywords: rehabilitation shoulder dysfunction cervical lymph node dissection head and neck cancer
assignment of the verbal component score and addition of pupil reaction to the glasgow coma scale

Conditions: Brain Injuries, Traumatic

Summary: in this study, it is aimed to determine the prognostic value of gcs-p and the gcs-p score, which is formed by assigning a verbal score, in patients with traumatic brain injury, where all parameters can be evaluated. in the model to be created, a new total score will be obtained with motor score + eye response + assigned verbal score-pupil score and this score will be compared with gcs and gcs-pupil score.


Eligibility criteria:
inclusion criteria: * admitted to hospital due to traumatic brain injury, * 18 years and older, * who were alive at the time of admission, * patients whose gcs and pupil reactivity can be evaluated completely. exclusion criteria: * younger than 18, * not alive at the time of admission, * patients whose gcs score and pupil reactivity are not correctly evaluated (facial trauma, past eye diseases or eye defects, etc.).

Keywords: gcs gcs-pupil score brain trauma consciousness
systemic reactions to allergen immunotherapy amd skin testing

Conditions: SYSTEMIC REACTION

Summary: allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis and treatment of atopic diseases. allergen immunotherapy has proved to be effective in reducing the symptoms of allergic rhinitis and asthma1-2. despite its clinical benefit, there is risk of systemic reactions associated with these procedures. the systemic reaction rate to skin testing for aeroallergens is significant lower than the rate of reactions to immunotherapy, but it is not negligible. lin et al reported only 2 patients who had systemic allergic reactions to skin testing for respiratory allergies in 10,400 patients tested.3 they determined the overall risk of inducing anaphylactic reactions by skin testing to be less than 0.02% and other studies have produced similar results.4-5 the rate of systemic reactions to skin testing is likely underscored. thompson et. al reported a systemic reaction rate of 6% of patients receiving skin testing.6 it is important to recognize the risk of systemic reactions seeing skin testing is commonly done. it is also imperative to recognize the treatments for these reactions to prevent progression. hypothesis the systemic reaction rate to allergen immunotherapy and skin testing to aeroallergens is higher than previously reported. biphasic anaphylactic reactions rarely occur with allergen immunotherapy and skin testing.


Eligibility criteria:
inclusion criteria: * male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice. exclusion criteria: * non male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Keywords: allergic reaction
impact of metabolic changes and vitamin d status on virological response in patients with hcv infection treated by daas

Conditions: HCV

Summary: 1. study changes in lipid profile and the impact of insulin resistance on virological response in patients with hepatitis c viral infection treated by direct acting antiviral agents 2. the assessment of serum vitamin d levels in hcv infected patients and predictive value of pre-treatment serum vitamin d level for achieving sustained virological response at 12 weeks post-treatment

patients and methods: this cross-sectional study will include 100patients of chronic hcv infection who attend el raghy assiut university hospital, either inpatients or outpatients. chronic hcv infection will be diagnosed based on detectable hcv rna with anti-hcv ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease. patients will receive treatment to hcv by daas and follow up for 12 weeks to confirm sustained virological response method: patients presenting in this study will be subjected to the following: 1. full history and clinical evaluation. 2. body weight (kg) and height (m). 3. bmi will calculate as weight divided by squared height (kg/m2). 4. waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together. 5. blood pressure (mmhg) was measured twice in the upper arm after a 10-min period of rest and taken an average. laboratory investigations will include: * complete blood count (cbc) * liver function test * hcv ab and hcv rna by pcr * hbs ag * alpha fetoprotein * lipid profile * serum urea and creatinine * fasting blood sugar (fbg)and serum fasting insulin level * insulin resistance determined via homeostasis model assessment (homa-ir) ir = fasting insulin (µu/ml) × fasting glucose (mmol/l) ----------------------------------------------------------------- 22.5 an index value of ˃ 2. 5 was defined as ir (huang et al., 2011) * vitamin d level: vitamin d deficiency wasdefined as a 25 (oh)-vitamin d serum level \< 20 ng/ml, vitamind insufficiency as 25 (oh)-vitamin d levels of 20 - 29.9ng/ml, and normal vitamin d levels ≥ 30 ng/ml (holick mf et al.,2011) * abdominal ultrasound * electrocardiogram (ecg)

Eligibility criteria:
inclusion criteria: * chronic hcv will receive daas for treatment exclusion criteria: 1. decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant 2. co-existing liver disease (hepatitis b virus, autoimmune hepatitis, human immunodeficiency virus) 3. extra-hepatic malignancy except after two years of disease free interval. 4. patients with diabetes mellitus. 5. patients with chronic kidney disease. 6. pregnancy or in ability to use effective contraception. 7. patients with history of using lipid lowering therapy 8. relapser or failure of previous hcv treatment
integrated care for inflammatory bowel disease patients in the netherlands with the novel telemedicine tool myibdcoach: a randomized controlled trial

Conditions: Inflammatory Bowel Disease

Summary: inflammatory bowel diseases (ibd) is an invalidating disease mainly diagnosed in young people. the disease is characterized by a heterogenic phenotype and the disease course by flares and remissions. as in most chronic diseases the economic burden of ibd is important due to direct health care costs and disability. health care reorganization for ibd patients in the netherlands is necessary for several reasons. first chronic (sub)clinical mucosal inflammation results in irreversible bowel damage and complications and none of the presently available drugs is effective for all patients and many drugs have possible severe side effects. to prevent complications of the disease and side effects ibd should be monitored carefully. in the netherlands however there is a shortage of gastroenterologists where the incidence of ibd is rising. secondly evidence exists that direct involvement of health care workers, patient empowerment and integrated care can improve the outcome of chronic diseases. thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not systematically followed in routine care. finally the government demands registration of efficacy endpoints for expensive drugs in the near future. therefore the investigators developed a web-based telemedicine tool for ibd patients in collaboration with the dutch ibd patient's organization (ccuvn). "myibcoach" contains e-learning modules, monitors disease activity, disability, quality of life, adherence, infections, smoking status, side effects, stress and malnutrition on fixed time points with validated questionnaires, allows the patient to communicate with health care workers and gives feedback to the back office and the patient. a feasibility study in 30 ibd patients in 3 centres showed a high satisfaction and compliance of ibd-patients and health care workers with this telemedicine tool. the aim of this study is to compare standard care for ibd patients in 3 hospitals with a care via the telemedicine tool myibdcoach.


Eligibility criteria:
inclusion criteria: * diagnosed ibd * age 18-75 years * patients who have access to internet by computer, tabloid or smartphone exclusion criteria: * not able to give informed consent * not able to understand and use the dutch language * in the two weeks after a hospital admission patients can not be included

Keywords: telemedicine patient empowerment integrated care
intraoperative investigation of a directional lead and local field potentials for the optimization of stimulation efficacy

Conditions: Parkinson

Summary: the current study aims to explore the functional use of lfps recorded intraoperatively for the optimization of a directional dbs lead programming aim-1: to determine whether intraoperative lfps recorded from the segmented dbs electrode can predict the optimal stimulation parameters. aim-2: compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral lfp patterns correlate with the presence of stimulation side effects.

this is a feasibility study designed to evaluate the usefulness of intraoperative lfp recordings obtained from the implanted dbs lead to predict ideal stimulation parameters. additionally this study will compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral lfp patterns correlate with the presence of stimulation side effects. approximately 15 subjects will be enrolled in this clinical investigation. the clinical investigation will be conducted at 2 centers in the usa. subjects participating in this clinical investigation will monitored during dbs implant procedure and programming. the expected duration of enrollment is 8 months. the total duration of the clinical investigation is expected to be 1 year.

Eligibility criteria:
inclusion criteria: * age 18-70 years * ability to provide informed consent * diagnosis of idiopathic parkinson's disease, and dbs consensus team review supporting the placement of stn dbs. exclusion criteria: * subject is not a surgical candidate; * in the investigator's opinion the subject unable to tolerate multiple programming sessions within a single setting; * subject unable to comply with the follow-up schedule
assessing the predictive value of high frequency algorithm of pure ep for low amplitude signal detection

Conditions: Cardiac Arrhythmias

Summary: prior multicenter study demonstrated superiority of pure ep to conventional mapping. this superiority was seen when comparing small, fractionated signals of interest, near-field vs far-field distinction, and general signal quality (2). hence, investigators propose a retrospective study to assess the predictive value of high frequency algorithm (hfa) for identifying local physiologic signal under 0.3 mv distinctive of noise.

accurate interpretation of intracardiac egms remains essential to the field of electrophysiology (ep). conventional electro-anatomical mapping systems (eams) have made significant improvements in egm quality and noise reduction since their emergence, however their use of variable gain amplifiers and high/low pass filters, often provide visualization of low amplitude signals that lead to saturation artifact or necessitate signal clipping. pure eptm (biosig technologies, inc., westport, ct, usa), in contrast does provide the ability to record this unaltered signal with more customizable display options. their proprietary amplifier and high-resolution analog-digital converters with radiofrequency (rf) suppression eliminates the need for gain switching, optimizing resolution of the full range of input signals (1). prior multicenter study demonstrated superiority of pure ep to conventional mapping. this superiority was seen when comparing small, fractionated signals of interest, near-field vs far-field distinction, and general signal quality (2). hence, investigators propose a retrospective study to assess the predictive value of high frequency algorithm (hfa) for identifying local physiologic signal under 0.3 mv distinctive of noise.

Eligibility criteria:
inclusion criteria: all patients (male + female) with age \> 18 years from january 2022 till june 2022 will be included in the study. exclusion criteria: all patients in which pure ep was not used from january 2022 till june 2022.
danish multicenter stent trial

Conditions: Ischemic Heart Disease; Stable Angina; Unstable Angina

Summary: the purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents


Eligibility criteria:
inclusion criteria: * stable, unstable or silent angina, * de novo lesion exclusion criteria: * allergy to ticlopidine * recent myocardial infarction * expected survival \> 1 year
study to see whether breath-hold techniques during rt are effective in helping to improve sparing of the heart

Conditions: Breast Cancer; Adverse Effect of Radiation Therapy

Summary: the study hopes to determine whether patients with left-sided breast cancer are at an increased risk of cardiac changes due to radiation to the breast +/- anthracycline-based chemotherapy +/- herceptin and whether a deep inspiration breath hold (dibh) technique during radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the conventional free breathing (fb) technique thus reducing cardiac toxicity as measured by cardiac mri using left ventricular end-diastolic volume (lvedv) as a metric. bio fluid samples will also be collected to investigate specific biomarkers of breast cancer: bnp, piiinp and citp

patients with left-sided breast cancer who receive adjuvant breast or chest wall radiation have increased risk of treatment related cardiovascular morbidity. the risk of cardiac morbidity and mortality is increased when a patient receives radiation following adjuvant chemotherapy and herceptin. the dose-volume histogram (dvh) parameters associated with increased cardiac toxicity include volume of heart irradiated, total radiation dose received by the left ventricle (lv), v25 and mean cardiac dose. even though modern rt treatments like 3dcrt and imrt can reduce the mean dose to the heart, the maximum dose to the left side of the heart/lv may not be reduced if the target is close to the heart. the hypothesis is that dibh rt can safely and effectively reduce the heart dose, especially the dose to the lv, that could lead to reduction in the incidence of radiation induced cardiovascular morbidity and mortality. radiotherapy has detrimental effects on cardiac function due to remodeling of the cardiac tissue that receive radiation. we believe that the radiation related acute effects on heart tissue can be detected with cardiac functional mri. the study will quantify the acute rt related effects. to our knowledge, cardiac mri has not been explored as a non invasive technique to quantify rt +/- chemotherapy related effects.

Eligibility criteria:
inclusion criteria: * female patients with pathologically confirmed left sided breast cancer eligible for adjuvant breast/chest wall plus or minus regional nodal radiotherapy * women patients with age group between 18 and 70 years old * karnofsky performance score ≥ 70 * ability to hold breath for at least 20 sec (for dibh cohorts only) * life expectancy \>10 years exclusion criteria: * for patients with prior anthracycline based chemotherapy or herceptin, if there is \< 1.0 cm of heart on at least 3 slices ( 3 mm slices) on the fb scan, the patient will be considered a screen failure. * previously irradiated or recurrent breast/chest wall tumours or previous malignancy other than non-melanoma skin cancer unless disease free for a minimum of 5 years prior to study entry * patients that require a shell for breast immobilization * patients requiring a boost * stage iv disease

Keywords: deep inspiration breath hold radiation therapy cardiac toxicity left-sided breast cancer