Model: martian786/TREC_Clinical_Trials_finetune_V1
Author: martian786
Pipeline: sentence-similarity
Library: sentence-transformers
Tags: sentence-transformers, safetensors, mpnet, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:11583, loss:TripletLoss, arxiv:1908.10084, arxiv:1703.07737, base_model:sentence-transformers/all-mpnet-base-v2, base_model:finetune:sentence-transformers/all-mpnet-base-v2, endpoints_compatible, region:us
Base models (finetune): id: sentence-transformers/all-mpnet-base-v2
Card metadata: tags: sentence-transformers, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:11583, loss:TripletLoss
base_model: sentence-transformers/all-mpnet-base-v2
widget: source_sentence: The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After  starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range:
TSH: 2.35 mU/L
Free T4: 2.7 ng/dl
Anti-TPO: 75 IU/ml
sentences: Subjects who meet inclusion/exclusion criteria will be entered into the randomized trial.
      Randomization will be 1:1 between control group and ablation group. Those randomized to the
      control group will receive ICD therapy and routine drug therapy (including antiarrhythmic
      drugs as indicated). Subjects randomized to the ablation group will receive ablation therapy
      plus ICD for ventricular tachycardia. Patients that refuse ICD therapy and undergo ablation
      only will be enrolled in a prospective registry.

      Follow-up will be performed prior to hospital discharge for incision check and device
      interrogation as is standard of care. In addition, routine device and clinical follow-up will
      be scheduled at 1, 3, 6, 12, 18, and 24 months. Electrocardiography (ECG) will be performed
      pre-implant and prior to hospital discharge. Echocardiography (TTE) will be performed
      pre-implant and at 12 and 24 months.

      Patients that refuse ICD implantation will not be randomized and will be approached for
      inclusion into a registry if they undergo catheter ablation without an ICD. Basic
      demographics and medical history will be collected from registry subjects upon enrollment.
      Registry subjects will receive follow-up for routine clinical care every 6 months to check on
      their overall status.

      120 subjects will be randomized. An additional 60 subjects will enrolled into the registry.

      As of the time protocol revision C changes were made (07Nov2016), 33 subjects have been
      randomized. There has not been any preliminary or interim analysis of any data at this point.
      The study-sponsor has not had any access to any clinical follow-up for the patients enrolled
      to date., This study is classified as a randomized double-blind clinical trial. Will be held in the
      Department of Physiotherapy of the university clinic of the Federal University of Pernambuco,
      located in University City, Recife-PE. Data for the survey will be collected during the
      course of the Masters in Physiotherapy, from April 2015 to September 2015, for further
      analysis.

      The analyzed groups shall consist of women aged 30-50 years referred to the Department of
      Physical Therapy - UFPE, with clinical diagnosis of fibromyalgia and migraine performed by
      doctors of Rheumatology clinics and Neurology, Hospital das Clinicas, UFPE. Being invited to
      participate and informed about its content, saying their participation by signing a Term of
      Consent. Data collection is in accordance with the Declaration of Helsinki, and will begin
      after the project was approved by the Ethics Committee for Research on Human beings of the
      Federal University Health Sciences Center of Pernambuco, in accordance with Resolution
      466/2012 of the National Research Ethics Committee of the Ministry of Health, the body that
      regulates research involving human subjects. The study will be registered in the digital
      Clinical Trials platform after obtaining the registration number of the Ethics Committee.
      Initially there will be a pilot study with 20 women, then the results will be used to
      calculate the sample size using the G Power (version 3.1.9.2, Germany), considering a
      statistical power (β) of 80% with a significance level (α) of 5%.

      Will be excluded those that have some other rheumatologic disease, cardio-respiratory or
      cardiovascular that prevents the realization of aerobic exercise protocol; low attendance
      during the implementation of the exercise program (over three consecutive absences);
      cognitive impairment or neurological disease that compromises the understanding and the
      exercises; Body mass index ≥ 30.0 (obesity, according to the World Society of Health);
      pregnant women and patients classified as level of active or very active physical activity by
      IPAQ (International Physical Activity Questionnaire).

      3.1. Randomization

      Initially, patients will undergo will a simple randomization through the site
      www.randomization.com, resulting in two groups:

        1. Aerobic Training: Submitted to a protocol consisting of heating, aerobic training with
           adequate heart rate and slowdown;

        2. Control Training: Heating Protocol with speed and low intensity (heart rate will next
           basal).

      Randomization will be performed by an examiner A, not research participant to ensure
      allocation concealment (patients and principal investigator will not be aware of which group
      are allocated). All women will be evaluated (both groups) through questionnaires and
      spirometry before the start and the end of the exercise protocol. Every four weeks, the
      patients will be submitted to revaluations through the questionnaires. The evaluation of
      these volunteers will be conducted by an examiner B (principal investigator), blinded to
      randomization; and the exercise protocol implementation will be the responsibility of the
      examiner C, only one will know to which group the patients belong. Corroborating the
      double-blinding, the evaluator to perform statistical analysis of the data will not know to
      which group belongs the results.

      3.2. Evaluation

        -  Socio-demographic questionnaire Prepared by the researcher to characterize the groups,
           which answer questions for identification and history (name, date of valuation,
           telephone, address, date of birth, age, weight, height, body mass index / BMI,
           profession, education, marital status, physical activity and frequency, use of
           medication, type of medication, medication time). One minunciosa history regarding the
           use of drugs will be held: types, frequency, duration of treatment.

        -  Identification of the impact of migraine Will be evaluated by the Migraine Disability
           Assessment Test (MIDAS), which contains five items that measure the amount of days lost
           in the activities of daily living (ADLs) and professional (AVPs) due to the presence of
           migraine in the last three months; the patient declares the amount of days and, from the
           result of the sum of the scores, ranks the degree of disability of the individual (0-5
           points: grade I / minimal disability; 6-10 points: grade II / mild disability; 11-20
           points: grade III / moderate disability;> 20 points: grade IV / severe disability).

        -  Clinical characteristics of the headache Will be filled the journal Headache, based on
           criteria established by the International Headache Society (ICHD-III beta version,
           2013); assesses the amount and duration of migraine attacks over a period of 30 days,
           pain intensity, symptoms associated with headache, medication use.

        -  Investigation of sleep quality The Pittsburgh Sleep Quality Index (PSQI), used to
           measure the subjective quality of sleep; consists of 19 items divided into seven
           components that punctuate 0-3 (total score of 0-21 points, the higher the score, the
           worse the quality of sleep). Was adapted and validated for the Brazilian population by
           Bertolazi and colleagues (2011), with a high reliability (α Cronbach = 0.82).

        -  Quality of life assessment Measured by the FIQ (Fibromyalgia Impact Questionnaire),
           consisting of 19 questions divided into 10 items: the first item has 10 sub-items with
           four response options ranging from 0-4 points; the second and third items, the patient
           should choose an option on a scale of 0-7; in the other, is given a score of 0-10 in
           response (the higher the score, the greater the impact of fibromyalgia on quality of
           life). Adapted and validated for the Brazilian population.

        -  Tracking of symptoms of anxiety and depression The presence of depression will be
           assessed by the Beck Depression Inventory (BDI), consisting of 21 questions that add up
           to a maximum score of 63 points (level of depression: 0-9 points = No; 10-18 points =
           mild depression; 19- 29 points = moderate depression;> 30 points = severe depression).
           It is validated and adapted for the Brazilian population, with a Cronbach's alpha of
           0.81. The Beck Anxiety (BAI) will be used to identify and classify anxiety; consists of
           23 statements that have the maximum score of 63 (0-10 points: minimum Anxiety, 11-19
           points: Light Anxiety, points 20-30: moderate anxiety,> 31 points: severe anxiety), is
           validated and adapted to Brazilian population.

        -  Evaluation of the level of physical activity Proposed by the World Health Organization
           (1998), the International Physical Activity Questionnaire (IPAQ) aims to measure the
           total physical activity level (AFT) from the energy expenditure (METs.min-¹). Will be
           used to short IPAQ (version 8), which consists of 4 questions with two sub-items (b) on
           activities of daily living, professional life activities and practice of walking; where
           the frequency and duration respond if (days and hours / minutes) of activities and its
           intensity (moderate or vigorous = 3.3-4 METs = 5.5 to 8 METs) for one week. From the
           data obtained, sum up the frequency and duration of activities (walk + moderate +
           vigorous intensity) and, from this result, classifies individuals in: sedentary;
           irregularly active; active or very active. This questionnaire is validated and adapted
           for the Brazilian population, with excellent reproducibility (ICC = 0.79).

        -  Assessment of exercise tolerance Ergospirometry or cardio-pulmonary function test
           assesses precisely, the cardio-respiratory capacity and metabolic by direct measurement
           of maximum oxygen consumption and determining the maximum ventilatory thresholds. He is
           currently considered the gold standard for evaluation of exercise tolerance by providing
           non-invasive and very precise exercise intensities featuring aerobic or anaerobic
           metabolism (anaerobic threshold - LA). It is the most appropriate test for prescription
           of aerobic exercise intensity in sedentary individuals or with regular physical
           activity. Oxygen consumption (VO2 max) appears to be the most accurate indicator of
           exercise capacity. The test will be performed on a treadmill, coupled with a spirometer
           and a computer system in a climatically standardized environment. To minimize air
           leakage, will be employed the use of face masks with tiny dead-space. The main
           parameters obtained in the test are the ventilatory thresholds: anaerobic threshold (AT)
           and respiratory compensation point, which will characterize the aerobic and anaerobic
           workouts. The variables obtained during the test, with clinical relevance are: maximal
           oxygen uptake (VO2 max), carbon dioxide release (VCO 2), rate of gas exchange (R),
           estimated lactate threshold, expired minute volume (VE) , ventilatory reserve (RVE),
           ventilatory equivalents, end-expiratory pressures (PEF), ventilatory pattern, arterial
           gas tensions / oxyhemoglobin saturation, physiological dead space, electrocardiograms,
           heart rate, peripheral O2 saturation (SpO2) and blood pressure (BP ).

      The responses to the cardiopulmonary exercise testing (CPX) are obtained by means of an
      incremental protocol, which consists in progressive load increases at predetermined time
      periods. A typical incremental protocol should provide: a resting phase (2-3 minutes or
      more), in which we observe a lack of hyperventilation before starting the test; a heating
      period with zero charge (2-3 minutes); incrementing a time (8-12 minutes) and an active
      period of recovery with no load (3-6 minutes if possible). For the intervention protocol,
      heart rate obtained just below the anaerobic threshold, recommended for proper intensity to
      gain fitness with greater security and compliance will be used. Generally, oxygen consumption
      levels in the anaerobic threshold are lower in these patients.

      -Re-Reviews Initially, will be held the evaluation of patients through questionnaires and
      cardiopulmonary stress test to investigate exercise tolerance before the start of exercise
      protocol (review 1). Every 4 weeks, the patients of both groups will be reassessed by the
      re-application of all questionnaires: 4 weeks - review 2; 8 weeks: evaluation 3. At the end
      of the 12 weeks of training, the review 4 will be held, with repetition of the questionnaires
      and cardiopulmonary exercise testing.

      3.3. Intervention protocol The intervention protocol will be made by the examiner C, one who
      is not blind to the research. After randomization and evaluation, patients will be allocated
      to one of the groups: experimental or control. After the evaluation of cardiorespiratory
      capacity of patients, will be established starting parameters appropriate to the level of
      physical activity each based on heart rate obtained just below the anaerobic threshold
      (ensuring aerobic work).

      The experimental group will follow the following protocol: performing heating for 5 minutes
      at low speed on a treadmill; after heating, the speed is increased gradually until the
      patient reaches the proper heart rate for aerobic training obtained during cardiopulmonary
      exercise testing, maintaining the same for 20 minutes to perform the aerobic workout;
      completed, the velocity will be decreased to regain speed heating maintained for 5 minutes
      and finishing training. It is envisaged that in practice using the FC to ensure proper
      aerobic exercise for 20-60 minutes at a frequency of 3-5 times per week are effective in
      increasing the functional capacity of individuals with low fitness (American College of
      Sports Medicine - ACSM, 2006). In the control group, these women will be guided to perform 10
      minutes of heating on the treadmill with a low speed that does not cause patient effort
      (monitored by the Borg scale and FC close to the basement).

      Both groups will be followed for 12 weeks, with a driving frequency of 3 times per week.
      Heart rate and saturation of peripheral oxygen (SpO2) will be continuously monitored through
      the use of finger pulse oximeter during the course of all practices of all the volunteers of
      research to ensure that HR is within the established for each group, Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb
      in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg.
      It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes
      against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX
      activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that
      If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be
      blocked by saturation of deficient stores of GPX solely and the mechanism of action requires
      more than repletion of deficient stores. It's important not only to estimate the optimal dose
      but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels
      in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment
      modality which can suppress the autoimmunity in more than 400 million AIT patients. Because
      there've been no way to suppress autoimmune war and replacement of LT4 had been the only
      treatment modality for palliation. An other independent part of the study is to test the
      effect of Se in adolescent AIT patients., source_sentence: 48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation.
During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease.
sentences: PART A The SAD treatment group is comprised of 3 cohorts where subjects will be randomized to
      either PTI-428 or placebo. Following the conclusion of at least 3 SAD treatment groups, a set
      of adult subjects diagnosed with CF will participate in an assigned MAD treatment group. The
      MAD treatment group is comprised of 3 cohorts. MAD Cohort 1 will enroll adult subjects with
      CF currently on stable ORKAMBI® background therapy for a minimum of 3 months at the time of
      randomization. MAD Cohorts 2 and 3 will enroll adult subjects with CF who are not currently
      on any background therapies. Subjects in all MAD cohorts will be randomized to either PTI-428
      or placebo. Each dose will be administered once daily (QD) for a total of 7 Days.

      PART B Following the conclusion of MAD Cohort 1, a set of adult subjects diagnosed with CF
      currently on stable ORKAMBI® background therapy for a minimum of 3 months will participate in
      Part B. The Part B Phase II treatment group is comprised of 2 cohorts where subjects will be
      randomized to either PTI-428 or placebo. Each dose will be administered QD for a total of 28
      days.

      PART C Following the conclusion of Part B Phase II, a set of adult subjects diagnosed with CF
      will participate in Part C. The Part C Phase II treatment group is comprised of 3 cohorts.
      Part C Cohort 1 will enroll adult subjects with CF who are eligible to take, but not
      currently taking, ORKAMBI® in accordance with the approved label. Part C Cohort 2 will enroll
      adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3
      months at the time of randomization. Part C Cohort 3 will enroll adult subjects with CF who
      are not currently on any background therapies and are pancreatic sufficient. Each PTI-428 or
      placebo dose will be administered QD for a total of 28 days., Major depressive depression(MDD) is an severe public mental disorders. The purpose of current
      study is using big data analysis based on clinical features and immunochemistry to
      investigate and establish an relapse predict model for patients with first episode MDD.

      This study includes two steps. Step 1: Big data analysis based on the clinical features and
      immunochemical figures of 30000 patients with first episode MDD will be conducted to
      construct a relapse predict model.

      Step 2: 300 patients with first episode MDD will be recruited in this step. Physicians prefer
      to give corresponding treatment recommendation based on the predictive factors to verify this
      relapse model., This study is an multicenter, single-arm, prospective, safety and performance clinical study., source_sentence: A 57-year-old man was admitted to the clinic because of weight loss and persistent dry cough 4 months ago. Chest computed topography showed bilateral multiple infiltrates in the upper lobes and thickened bronchial walls. There is a documented positive serum MPO-ANCA in his medical record. Transbronchial biopsy revealed necrotic granulomas with multinucleated giant cells and the Wegener's granulomatosis was diagnosed for him. He is treating with corticosteroid and cyclophosphamides since 4 months ago. His Birmingham Vasculitis Activity Score (BVAS) is above 4 since the beginning of his disease. His last physical exam and lab study was performed yesterday and showed the results bellow:
A wellbeing, well-nourished man, non-icteric, cooperative and alert
Weight: 73 kg
Height: 177
BP: 120/80
HR: 90/min
RR: 22/min
Hgb: 13 g/dl
WBC: 8000 /mm3 (Neutrophil: 2700/mm3)
Plt: 300000 /ml
AST: 40 U/L
ALT: 56 U/L
Alk P: 147 U/L
Bill total: 1.2 mg/dl
ESR: 120 mm/hr
MPO-ANCA: 153 EU
sentences: In this study, an oral nutrition supplement has been developed that take into consideration:
      the nutritional requirements, treatment side-effects and taste preferences of head and neck
      cancer patients; the acceptance of a supplement when experiencing radiation therapy
      side-effects; and the taste preferences of head and neck cancer patients which may affect the
      supplement intake. We hope to increase dietary intake during the last 2 weeks of radiation
      therapy., The objective of the work described in this protocol is to determine the optical signatures
      of cervical dysplasia using optical technologies., The ANCA-associated vasculitides can be life threatening. Glucocorticoids and
      cyclophosphamide therapy is effective in about 80% patients. However, the side effects such
      as bone marrow suppression, infection, cystitis, infertility, myelodysplasia preclude further
      use of cyclophosphamide in some patients and the relapse rate is high.

      Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate
      mofetil(MMF), could exhibit multifarious effects on endothelial cells, including inhibition
      of ICAM-1 expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis,
      which contribute to the efficacy of MMF in the treatment of vasculitic lesions such as lupus
      nephritis with vasculitic lesions. This study was a feasibility study to assess the safety
      and effectiveness of MMF in inducing remission in subjects with ANCA-associated SVV compared
      with pulse intravenous cyclophosphamide. After enrollment, subjects were followed
      longitudinally, and formal measurements of disease activity were determined using the
      Birmingham Vasculitis Activity Score (BVAS)., source_sentence: The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife.  They have three children.  He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in.  His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs.
sentences: The investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG
      to 130Hz stimulation and dopaminergic medications for two visits of at least 6-month apart.
      The 6 patients remaining on 60Hz stimulation after our previous study consisting of 7
      patients will be assessed once again as visit-2 after previous visit-1 of their last study.
      We anticipate to have 20 patents complete for visit-1 and at least 18 patients complete for
      visit-2 in this randomized double-blind prospective crossover study with their usual
      medication "on" state, with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS
      off). Swallowing function on modified barium swallowing test and swallowing questionnaire,
      FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III
      will be assessed under each DBS condition. Changes in measurements between 60Hz and 130Hz at
      each visit and under 60Hz between two visits will be analyzed, with swallowing function and
      FOG as primary, and the rest as secondary outcomes, correcting for potential carryover
      effect. Changes between other DBS conditions might also be explored in this 2-year study.

      This would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG
      and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and FOG
      refractory to 130Hz stimulation and dopaminergic medications, which will have significant
      impact on the treatment of difficult axial symptoms of high morbidity and mortality., Approximately 28,900 patients will be diagnosed with squamous cell cancers of the oral cavity
      and pharynx in the year 2002. Of these, an estimated 7,400 patients will present with
      metastases or develop recurrent disease, which is not amenable to surgery or radiation
      therapy. Palliative chemotherapy is thus the only treatment option. Currently, combinations
      of cisplatin and 5-fluorouracil are used as first line treatment strategies, with median
      times to progression of 2.5 to 3 months and median survival rates of 5 to 7 months. The time
      to achieve maximum response with combination therapy is on average 4 months.

      Taxanes, with their unique mechanism of microtubule stabilization, have demonstrated response
      rates similar to standard, first line combination regimens. Several phase II studies have
      evaluated the efficacy of single agent docetaxel in head and neck cancer patients. Cumulative
      response rates were approximately 30%, with higher response rates observed in patients
      receiving no prior chemotherapy. Docetaxel has also been used in combination with cisplatin
      and cisplatin and 5-fluorouracil. Although response rates with such combination regimens were
      superior to the use of single agent docetaxel, grade 3 and 4 toxicities were also more
      prevalent.

      Capecitabine (Xeloda®), a fluoropyrimidine carbamate, is an oral prodrug, which is converted
      in tumor tissues to 5-fluorouracil through multienzymatic activation. Capecitabine (Xeloda®)
      has documented activity in breast and colorectal cancers and is widely administered. Because
      5-fluorouracil has efficacy in the treatment of head and neck cancer, it is reasonable to
      consider that such tumors will respond to capecitabine. To date, there are no published
      trials using capecitabine (Xeloda®) in the treatment of metastatic head and neck cancer
      patients. However, clinical trials are ongoing in the U.S. and Europe with promising results.

      In preclinical models, a synergistic interaction between capecitabine and docetaxel has been
      documented. One possible explanation for the synergy is that docetaxel up-regulates tumor
      levels of thymidine phosphorylase, the enzyme essential for the activation of capecitabine
      and 5'-dFUrd to 5-fluorouracil. Clinically, O'Shaughnessy, et al. recently reported improved
      survival with docetaxel/capecitabine combination therapy in patients with metastatic breast
      cancer, who previously failed anthracycline-containing chemotherapy. In this phase III study,
      patients were stratified according to previous exposure to paclitaxel and then randomized to
      capecitabine (Xeloda®) (1250 mg/m2 twice daily, days 1-14) plus docetaxel (75 mg/m2 day 1,
      repeated every 21 days) versus docetaxel alone. Grade 3 and 4 toxicities were more common in
      the docetaxel/capecitabine combination arm. Capecitabine (Xeloda®) and docetaxel were
      interrupted and the dosages reduced by 25% in patients who experienced a second occurrence of
      a given grade 2 toxicity, or any grade 3 toxicity, suggesting that the starting dosages were
      perhaps too high.

      The role of chemotherapy in metastatic head and neck cancer is limited to palliation of the
      symptoms of disease. Platinum and 5-fluorouracil combinations remain standard first line
      treatment strategies. The taxanes have been shown to have similar efficacy to such first line
      regimens and are often used as salvage treatment for patients with metastatic disease. Given
      that docetaxel has documented clinical efficacy in head and neck cancer and that there are
      preclinical data to suggest synergy with docetaxel and capecitabine, it is reasonable to
      consider using these agents in combination to treat head and neck cancer patients. Moreover,
      capecitabine and docetaxel have distinct mechanisms of action and no overlap of key
      toxicities. A recent phase I/II study by Tonkin, et al. in metastatic breast cancer patients
      demonstrated activity and less toxicity when docetaxel 30 mg/m2/week (day 1 and 8 q21 days)
      was combined with capecitabine 1800 mg/m2/day (14 of 21 days). In another phase I study by
      Nadella, et al. weekly docetaxel (36 mg/m2 ) was combined with 14 days of capecitabine (up to
      1500 mg/m2/day) over a course of 28 days. Antitumor responses were observed in patients with
      breast, colon, and bladder cancers. Hence, we propose this study whereby patients with
      previously treated, metastatic/recurrent head and neck cancer will receive treatment with
      docetaxel and capecitabine.

      To reduce the potential for toxicity, we will use a modification of the Nadella regimen.
      Docetaxel will be administered weekly at a dosage of 30 mg/m2 for 3 out of every 4 weeks and
      capecitabine will be administered at a flat dosage of 2000 mg per day (1000 mg p.o. b.i.d.)
      for two weeks out of every 4 weeks. The justification for using a flat dosage of capecitabine
      versus a calculated dosage is based on pharmacokinetic data that show no change in clearance
      of capecitabine with changes in BSA. We plan to use a fixed dose of 2000 mg qd (1000 mg q am
      and 1000 mg q pm). Fixed dosing of capecitabine is convenient and feasible, as shown in a
      prior University of Michigan study in breast cancer patients. In another study Schott, et al.
      informally piloted the combination of weekly docetaxel 36 mg/m2 and 1500 mg twice daily (3000
      mg/day) x 14 days capecitabine in metastatic breast cancer patients, and found it to be
      without unexpected or untoward side effects. Additionally, to take advantage of the time
      course of upregulation of TP in the preclinical models, the capecitabine dose will be given
      on days 5-18. In a flat dosing scheme, the Nadella regimen would have administered an average
      dose of 2125 mg qd for 14 days, assuming an average BSA of 1.7 m2. We plan to round this
      dosage downward to 2000 mg per day x 14 days; therefore, our regimen will use a slightly
      lower dosage of capecitabine. We feel that our proposed slightly lowered dose (closer to
      Nadella phase I dosing vs. Tonkin) of capecitabine is justified for the following reasons:

        1. The Nadella study was performed in a group of patients with solid tumor malignancies
           that were refractory to conventional therapy or for whom no effective therapy existed.
           ECOG performance status (PS) was 1 or 2 in 5/17 (30%) patients, 10/17 patients had
           received 2 or more lines of previous chemotherapy, and 7/17 patients had received
           previous radiotherapy. Based on data from previous treatment of head and neck cancer
           patients at the University of Michigan, the patient population to be enrolled in this
           trial is expected to be 60% PS 0 and 40% PS 1, and some will have received prior
           chemotherapy and/or radiotherapy. Like the Nadella patient population, a majority of our
           patients have been pretreated and are of poorer health.

        2. Dose interruptions and modifications are built into the protocol so that appropriate
           changes in treatment can be made in patients with Grade I or II toxicity, before the
           toxicity becomes Grade III or greater. Since the docetaxel is given weekly, and the
           capecitabine is administered daily, if patients are experiencing toxicity within a
           cycle, the dose of either can be held or modified., Perampanel is a non-competitive antagonist of the AMPA (
      2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved
      by the European Medicines Agency as adjunctive treatment for partial-onset seizures in
      patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and
      safety of perampanel as add-on treatment in patients with refractory epilepsy.

      The investigators retrospectively collected and analyzed the data of patients with refractory
      epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In
      total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean
      duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD =
      2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the
      responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were
      reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%),
      dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1)., source_sentence: 41 year old man with history of severe intellectual disability, CHF, epilepsy presenting with facial twitching on the right and generalized shaking in at his NH which required 20 mg valium to cease seizure activity. Per outside medical patient was felt to have focal epilepsy with secondary generalization, likely due to anoxic brain injury at birth, and probably related to the atrophic changes seen on MRI, particularly in the left temporal lobe.
The patient first developed seizures at age 13 found by family to have a generalized convulsion. He had a second seizure two years after his first episode. He was maintained on Dilantin and phenobarbital. The patient went 20 years without another seizure. He was recently tapered off Dilantin, and it was felt that perhaps this medication was necessary to maintain him seizure free. The patient had no further events during the hospital course and was back at his baseline at the time of discharge. Full EEG reports are pending at the time of dictation.
Past Medical History:
Epilepsy as above, CHF, depression
sentences: The purpose of this study is to characterize

      1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of
      de-identified patient records., BACKGROUND There is no consensus regarding the injury mechanism in complex prolonged Whiplash
      Associated Disorders (WAD) cases. Often, tissue damage and physiological alterations is not
      detectable. In order to improve future rehabilitation, a greater understanding of the
      mechanisms underlying whiplash injury and their importance for treatment success is required.
      It is also important to investigate if pathophysiological changes can be restored by
      rehabilitation.

      AIM The projects aims to investigate neck muscle structure and function, biomarkers and the
      association with pain, disability and other outcomes before and after neck-specific
      exercises.

      METHODS Design These are sub-group trials, each one independent of the others, in a
      prospective, multicentre, randomized controlled trial (RCT) with two parallel treatment arms
      conducted according to a protocol established before recruitment started (ClinicalTrials.gov
      Protocol ID: NCT03022812). Physiotherapist-led neck-specific exercise previously shown to be
      effective for the current population constitutes the control treatment for the new
      Internet-based neck-specific exercise treatment. In the RCT, a total of 140 patients will be
      included (70 from each group), whereof 30 (both randomization arms equally) consecutively
      will be asked to participate in the present sub-group study. The sub-group studies aims to
      start September 2019. Independent physiotherapists in primary health care will distribute the
      treatment.

      In sub-group of individuals, additional measurements will be performed before and after
      interventions end (3 months follow-up). The physical measurements will be performed by
      independent specially trained test-leaders blinded to randomization.

      Additionally, 30 neck healthy individuals without serious diseases matched for age and gender
      will consecutively be investigated.

      Study population

      The inclusion criteria for patients are:

        -  Chronic neck problems corresponding to WAD grades 2-3 verified by clinical examination

        -  Average estimated pain in the last week at least 20 mm on the visual analogue scale
           (VAS)

        -  Neck disability of more than 20% on the Neck Disability Index (NDI) [10]

        -  Working age (18 - 63 years)

        -  Daily access to a computer/tablet/smart phone and Internet

        -  Neck symptoms within the first week after the injury (i.e., neck pain, neck stiffness,
           or cervical radiculopathy).

      For the present sub group study additional criteria were:

        -  Right handed

        -  Dominant right sided or equal sided pain

      Inclusion criteria for healthy controls:

      • Age and gender matched healthy individuals without neck pain and disability (VAS <10mm, NDI
      <5%) that feel overall healthy without known diseases.

      Exclusion criteria for patients:

        -  Individuals with any of the following signs of head injury at the time of whiplash
           injury will be excluded: loss of consciousness, amnesia before or after the injury,
           altered mental status (e.g., confusion, disorientation), focal neurological changes
           (changes in smell and taste).

        -  Previous fractures or dislocation of the cervical spine

        -  Known or suspected serious physical pathology included myelopathy,

        -  Spinal tumours

        -  Spinal infection

        -  Ongoing malignancy

        -  Previous severe neck problems that resulted in sick leave for more than a month in the
           year before the current whiplash injury

        -  surgery in the cervical spine

        -  Generalized or more dominant pain elsewhere in the body

        -  Other illness/injury that may prevent full participation

        -  Inability to understand and write in Swedish

      Additional criteria in the present sub group:

        -  Increased risk of bleeding,

        -  BMI >35

        -  Contraindications of MRI such as metal, severe obesity, pacemaker and pregnancy.

      Exclusion criteria for healthy controls:

        -  Earlier neck injury,

        -  Recurrent neck pain,

        -  Earlier treatment for neck pain.

        -  Increased risk of bleeding,

        -  BMI >35

        -  Contraindications of MRI

      Recruitment and randomization Information about the study will be provided by healthcare
      providers, reports in newspapers, social media, and the university's website. Interested
      patients will contact the research team through the project website. After completing a small
      survey on the website, a project team member (physiotherapist) will perform a telephone
      interview and ask about the patient's medical history. An appointment for a physical
      examination and additional interview for the present sub-group study is made as a last step
      to ensure that the criteria for study participation are met. If the study criteria are met,
      written and oral informed consent are obtained, and the patient will fill out a questionnaire
      and undergo physical measurements of neck-related function. Baseline measurements must be
      completed for inclusion.

      Healthy individuals will consecutively be recruited among friends, family and staff at the
      university or the university hospital to suit the age and gender of a patient.

      Intervention for the patient group The intervention consists of neck-specific exercises
      distributed in two different ways, twice a week at the physiotherapist clinic for 3 months
      (NSE group) or with 4 physiotherapy visits only combined with a web-based system (NSEIT
      group).

      A. In the NSE group, patients will get an explanation and justification for the exercise
      consisting of basic information about the musculoskeletal anatomy of the neck relevant to the
      exercises given by the physiotherapist in order to motivate the patient and help make them
      feel safe and reassured. The patients undergo a 12-week training programme with a
      physiotherapist 2 days/week (total 24 times). Exercises are chosen from a clear and written
      frame of exercises. The training includes exercises for the deep neck muscles, continuing
      with the endurance training of neck and shoulder muscles. The exercises are individually
      adjusted according to the individual's physical conditions and progressively increased in
      severity and dose. Exercise-related pain provocation is not accepted. The patient may also
      perform exercises at home. At the end of the treatment period, the participants are
      encouraged to continue practising on their own. The exercises have been used with good
      results in previous RCTs.

      B. In the NSEIT group, patients will receive the same information and training programmes as
      the NSE group, but with 4 visits to the physiotherapist instead of 24. Exercises are
      introduced, progressed, and followed up to ensure correct performance. The exercises are
      performed and most of the information is given with the help of Internet support outside the
      healthcare system. Photos and videos of the exercises (a clear stepwise progression) and
      information are available on the Web-based system. A SMS reminder is automatically available
      if the exercise diary is not completed. The time required for training is the same as in
      group A, but without the patient having to go to the physiotherapy clinic. The Internet
      programme was developed by experienced physiotherapists/ researchers together with
      technicians and clinicians. Technicians are available to assist the participants if any
      technical difficulties arise. The patients will be introduced to the exercises and get
      information and support at the physiotherapy visits.

      Variables and measurements Background data and data in the RCT include personal details,
      questionnaires and test results regarding pain, physical and psychological functioning,
      health and cost-effectiveness described elsewhere (ClinicalTrials.gov Protocol ID:
      NCT03022812).

      Measurements will be done at baseline for both groups and at 3 months follow-up for the
      patient when treatment ends. Except for blood and saliva samples that will be collected twice
      (baseline and repeated after 3 months), the measurements will be performed at baseline only
      for the healthy individuals., Mesial temporal lobe epilepsy (MTLE) is the most common cause of medication-resistant
      epilepsy in adults. The standard treatment for refractory MTLE is surgical resection by
      craniotomy. Stereotactic laser interstitial thermal therapy (LITT) is a new surgical
      technique being used to treat MTLE. Under MRI-guidance, a laser probe is inserted into the
      seizure focus and heat is used to destroy the tissue. Compared to temporal lobectomy, LITT
      results in shorter hospital stays, low complication rates, and possibly less cognitive
      decline; however, seizure freedom rates are potentially lower.

      During temporal lobectomy, neurophysiologic intraoperative monitoring (NIOM) can be used to
      better identify epileptogenic tissue and guide resection. This tool has been unavailable
      during LITT procedures. Recently, the investigators demonstrated in two cases that NIOM with
      a depth electrode is technically feasible during LITT and can identify epileptiform activity
      intra-operatively.

      This is a prospective trial of NIOM during LITT for mesial temporal lobe epilepsy. The
      investigators will assess the safety of performing NIOM during LITT and whether data from
      NIOM (frequency and characteristics of epileptiform discharges recorded before and after
      ablation) are associated with seizure outcomes. If there is an association, NIOM could be
      used for prognostication and could potentially even be used to guide surgery.

      Hypotheses:

        1. NIOM performed by MRI-guided stereotactic depth electrode placed in the parahippocampal
           gyrus adjacent to the LITT catheter is safe, as compared to institutional LITT controls
           without NIOM and published LITT complication rates.

        2. Greater magnitude fractional decrements in discharge frequency from pre-ablation to
           post-ablation recordings will be significantly associated with better seizure outcomes,
           as measured by International League Against Epilepsy (ILAE) surgical outcome scores.

      Objectives:

      The primary project goals are to assess if NIOM by parahippocampal depth electrode is safe
      during LITT of MTLE and to assess if the fractional decrement of interictal discharges (ID)
      on NIOM can be significantly correlated with outcome. The study will be powered to address
      these questions a priori. Post hoc analyses consisting of a multivariate analysis of other
      patient demographic data, NIOM findings, operative parameters, quality of life scores, and
      neuropsychiatric outcomes will also be assessed.
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