Kornimate/medical-research-clean huggingface dataset:
pain multidisciplinar intervention in major trauma patients

Conditions: Trauma; Chronic Pain; Psychological Trauma

Summary: in spain, major trauma continues to be the leading cause of death among young people. however, mortality rates represent only a relatively small part of the impact of trauma injuries on the health of the population. pain and anxiety are two of the most poorly controlled factors that have a huge impact on a patient's quality of life.the type of therapy that has been shown to be most effective in treating post-traumatic pain is one that involves different specialists, given its multicausality, care should be multidisciplinary. this investigation project consists in an observational study performed by a multidisciplinary team in our center. major trauma patients with moderate, severe or incapacitating pain will be referred to consultations specialized in chronic pain and psychology. one year after the trauma, patients will be evaluated in terms of quality of life. the aim of this study is to determinate the impact that multidisciplinary treatment of post-traumatic pain has on the perception of quality of life in severely injured patients.


Eligibility criteria:
inclusion criteria: * major trauma patients with moderate, severe or incapacitating pain (according to eq-5d-5l scale). exclusion criteria: * death in the first 30 days after the trauma. * transferred to another center.
induction of cortical plasticity

Conditions: Adult Brain Tumor

Summary: the study aims to induce plastic reorganization by a therapeutic protocol to increase the rate of gross total resection (gtr) and to optimize the oncological result.

regarding the therapy of cerebral parenchyma tumors, the extent of resection (eor) has a significant impact on the prognosis. however, total resection is not possible in up to 65% of cases because these tumors frequently infiltrate eloquent areas such as language or motor centers. consequently, an optimal oncologic result from the surgical perspective cannot be achieved in a considerable large amount of patients. one possible solution is based on the tumor-induced shift of functional areas, which can move away from their original localization. earlier studies already described the resection of glioma residuals during a second surgery after plastic reorganization has taken place. the authors complained that this reorganization is not detectable without surgery. navigated transcranial magnetic stimulation (ntms) was developed for the noninvasive localization of motor and language areas, which enables us to detect the spatial shift of cortical motor and language functions in tumor patients. recent publications were already able to demonstrate that the individual and exact localization of the motor cortex leads to an increased eor and prolongs the progression-free survival (pfs). therefore, the current project intends to take advantage of this plastic reorganization for eor optimization in cerebral parenchyma tumors. in this context, ntms is supposed to also induce this plasticity within the frame of a repetitive stimulation protocol (rtms). besides other therapeutic applications, rtms also showed a positive effect on the improvement of aphasia as well as motor recovery in patients after stroke, even in randomized multicenter studies, by inducing plastic reorganization. moreover, rather than waiting for tumor-induced plastic reorganization, the investigators also aim to use the potential of rtms for spatial plastic reorganization of functional areas adjacent to intracerebral parenchymal tumors to move functionally eloquent brain regions away from the planned resection cavity.

Eligibility criteria:
inclusion criteria: * intracerebral tumor * cortical function is located within planned resection area as confirmed by preoperative navigated transcranial magnetic stimulation and/or intraoperative direct electrical stimulation mapping * informed consent for participation * age \>18 years exclusion criteria: * prognosis less than 6 months * contraindications for mri or ntms (cardiac pacemaker, deep brain stimulator, cochlea implant * karnofsky-performance-index \<60%
a hospital-based registry of preventive cardiology clinics

Conditions: Cardiovascular Morbidity; Cardiovascular Risk Assesment; Primary Prevention CVD

Summary: more research is needed to articulate the most effective ways to use these tools as screening tests in cardiovascular risk assessments and how they ultimately affect cvd mortality and morbidity outcomes. clinicians are encouraged to continue sharing decision-making with patients to combine their unique cardiovascular risk factors and develop a comprehensive, effective treatment plan.

study design: observational study duration of study: ongoing. sample size: all patients presenting to preventive cardiology clinics at the national institute of cardiovascular diseases (nicvd), karachi, pakistan.. sampling technique: non-probability consecutive sampling data collection procedure: verbal informed consent will be obtained from all the patients regarding their participation in the study and publication of study findings while maintaining confidentiality. consecutive patients presenting preventive cardiology clinics at the national institute of cardiovascular diseases (nicvd), karachi, pakistan, will be included in this registry. demographic characteristics, physical examination, clinical history, risk modification, lab assessment, and ascvd risk score at presentation and at every follow-up will be recorded using a structural questionnaire. data analysis procedure: the tentative analysis plan uses collected data for research publications. the statistical package for social sciences (spss 21) will be used to analyze baseline characteristics. the shapiro-wilk test will be applied to check the hypothesis of normality for quantitative (continuous) variables. descriptive statistics such as mean ± sd, median (iqr), skewness, maximum, and minimum will be calculated for quantitative (continuous) variables. frequency and percentages will be calculated for categorical variables.

Eligibility criteria:
inclusion criteria: * all individuals attending the preventive cardiology clinics. exclusion criteria: * • individuals who refused to give consent.
non-small cell lung cancer registry

Conditions: Non-Small-Cell Lung Cancer; Pleural Effusion, Malignant

Summary: this trial will evaluate two separate groups of patients with stage iiib/iv non-small cell lung cancer. the objective of group 1 is to investigate an fda-approved drug in stage iiib/iv non-small cell lung cancer patients that has spread to the bones. the objective of group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. this trial is seeking patients 18 years or older that have been diagnosed with stage iiib or stage iv non-small cell lung cancer that cannot be treated by surgery.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * histologically confirmed nsclc (squamous cell carcinoma, adenocarcinoma, large cell carcinoma). * unresectable stage iiib with pleural effusion or stage iv nsclc * ecog performance status of 0 or 1 exclusion criteria: * patients who received an iv bisphosphonate (e.g.pamidronate; zoledronic acid) * patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate) * patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys * known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate) * abnormal renal function or creatinine clearance * unstable brain metastasis * women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding * patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol

Keywords: lung cancer bone metastases bone markers ntx zoledronic acid registry unresectable stage iv non small-cell lung cancer (nsclc) unresectable stage iiib nsclc with pleural effusion
post-authorization safety surveillance study of asenapine in participants with bipolar disorder (p08307)

Conditions: Bipolar Disorder; Schizophrenia

Summary: this study will assess asenapine (sycrest®) use in participants with bipolar disorder; comparison will be made to the use of risperidone (risperdal®consta®) and olanzapine (zyprexa®). the occurrence of identified and potential clinically important risks will also be assessed.


Eligibility criteria:
inclusion criteria for the bipolar disease cohort: * a diagnosis of bipolar disorder exclusion criteria for the bipolar disease cohort: * none inclusion criteria for the potential schizophrenia cohort: * a diagnosis of schizophrenia exclusion criteria for the potential schizophrenia cohort: * a prior and/or concomitant diagnosis of bipolar disease

Keywords: mania manic depressive manic depressive
chemotherapy with or without surgical resection in locally advanced esophageal cancer

Conditions: Esophagus Cancer

Summary: in this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. all patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-fu, and radiation therapy to 45 gy. at the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 gy, along with one additional course of chemotherapy.

upon determination of eligibility, all patients will receive neo-adjuvant therapy with: paclitaxel + carboplatin + 5-fluorouracil + radiation after neo-adjuvant therapy and restaging are completed, patients will be randomized to receive one of two treatments: * surgical resection (arm a) * paclitaxel + carboplatin + radiation (arm b)

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage i, ii, or iii. * received no previous treatment for esophageal cancer. * measurable or evaluable disease * able to perform activities of daily living with minimal assistance * adequate bone marrow, liver and kidney function * be at least 3 weeks from any major surgical procedures. * have an indwelling central venous access catheter. * patients must be able to understand the nature consent of the study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * age \< 18 years * history of a prior malignancy within the past 5 years * history of significant heart disease * inoperable on the basis of co-existent medical problems please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
df4 master study (safety and efficacy study)

Conditions: Ventricular Tachycardia; Ventricular Fibrillation; Sudden Cardiac Death; Heart Failure

Summary: the purpose of the study is to proof the safety and efficacy of the new icd sytem (iforia/ilesto). the devices are available with df-1 and df4 connection. a special focus is set on the icd system with df4 connection.


Eligibility criteria:
inclusion criteria: * patient has provided written informed consent. * patient has standard icd/crt-d indication. * patient accepts home monitoring concept. * patient is able to attend the planned hospital follow-up visits. * patient has legal capacity and ability to consent. exclusion criteria: * patient has a standard contra-indication for icd/crt-d therapy. * age \< 18 years * patient is pregnant or breastfeeding. * patient is expected to receive ventricular assist device or heart transplantation within the next 12 months. * life expectancy of less than 12 months. * participating in any other clinical study of an investigational cardiac drug or device.
a study to evaluate the safety and effectiveness of restylane-defyne for punctual occlusion

Conditions: Mild to Moderate Dry Eye Disease

Summary: a study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with restyalne defyne and the other eye injected with saline solution. participants will be evaluated over four visits.


Eligibility criteria:
inclusion criteria: * twenty-one (21) to 80 years of age * baseline ocular surface disease index score of at least 13 with no more than 3 responses of "not applicable" for each eye individually * in the study eye, a baseline schirmer test with anesthetic of ≤ 10 mm/5 minute * literate, able to speak english and able to complete the questionnaire independently * willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. exclusion criteria: * use of ophthalmic cyclosporine or lifitegrast within 30 days prior to day 0. * history of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery. * corneal transplant in either eye * ocular surgery (such as cataract surgery or lasik) in either eye within six months of the baseline visit. * a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease). * the history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer. * active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e. antihistamines, decongestants, oral or aerosol steroids). * use of steroids, including administration by systemic, inhaled or topical ocular routes (dermatologic steroids not applied to the eyelids are allowed). * participation in a clinical trial during the past 30 days * women who are pregnant, planning a pregnancy, or nursing at study entry

Keywords: dry eye disease restyalne defyne
a randomized,double blind, placebo controlled study to assess efficacy,safety and tolerability of bgg492 in migraine prevention

Conditions: Patients With Migraine Equal of /More Than 3 and Equal of/ Less Than 12 Migraine Attacks/4 Weeks for Each of the Last 6 Months Preceding the Screening

Summary: it will provide a first evaluation of efficacy, safety and tolerability of bgg492 in patients with non-chronic migraine having more than 3 and less than 12 migraine attacks per 4 weeks.


Eligibility criteria:
inclusion criteria: * male and female smoking and non-smoking subjects of 18 to 65 years of age (inclusive) * patients diagnosed with non-chronic migraine with or without aura of duration of at least 12 months prior to the study start * patient diagnosed with migraine (according to the international headache society categories 1.1 and with equal to/more than 3 and equal to/ less than 12 migraine attacks per 4 weeks for each of the last 6 months preceding the screening * patients willing to abstain from activities that require focused attention, e.g. driving a car or other vehicles, operating machines or engaging in potentially dangerous activities that require focused attention and intact physical balance exclusion criteria: * patients diagnosed with basilar, ophthalmoplegic or hemiplegic migraine as shown in the current/past medical history. * patients having an experience of non-migraine headaches on more than 6 days per 4 weeks in the past 6 months prior to study start * patients receiving regular treatment during the four (4) weeks preceding the baseline with psychoactive drugs (e.g. hypnotics, benzodiazepines, neuroleptics) except antidepressants (eg. ssris, snris, tri- or tetracyclics). * patients receiving migraine prevention medications during past three (3) months preceding baseline * patients receiving topiramate as migraine prevention medication during past six (6) months preceding baseline * patients receiving metamizole as acute treatment of migraine during past three (3) months preceding baseline * patients using (or having used within four (4) weeks before the treatment start) drug treatments that are potent inhibitors of oatp transporters (e.g. rifampin). * any psychiatric condition (e.g., schizophrenia, dementia, bipolar disorder) as shown in the past medical history prior to study start * patients with recent (within the last three \[3\] years prior to study start) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, orthostatic hypotension etc.). * pregnant or nursing (lactating) women. baselines (1 and 2). * patients with history of drug or alcohol abuse within the 12 months prior to dosing other protocol-defined inclusion/exclusion criteria may apply

Keywords: non-chronic migraine, migraine prevention
comparison of intraoperative intravenous lidocaine infusion and transversus abdominis plane (tap) block for post-operative analgesia following laproscopic cholecystectomy

Conditions: Post Operative Pain

Summary: this study is aimed to determine the post operative pain after laparoscopic cholecystectomy by dividing patients into three different group. group a will receive lidocaine 2mg/kg bolus at induction followed by 1.5mg/kg/hr infusion. group b will receive bilateral subcostal tap block with 0.375% 20ml ropivicaine on each side. group c will not receive any additional pain regime apart from the routine intraoperative analgesics. pain score will be assessed post operatively for 24 hours at regular intervals using visual analog score.


Eligibility criteria:
inclusion criteria: * age group (18-65) * undergoing elective laproscopic cholecystectomy * asa status i or ii exclusion criteria: * participation in any other trial * known hypersensitivity to study medications * chronic opioid used * seizure disorder
the mi-heart project

Conditions: Myocardial Infarction; Coronary Disease

Summary: the purpose of the study is to examine ways in which a clinical information system can help patients better recognize the signs and symptoms of an acute myocardial infarction (heart attack) and to take actions to decrease morbidity and mortality that may be related to delay in seeking treatment. the software-based intervention will use the best scientific evidence to create tailored strategies using a patient's specific health data. this approach is based on well-established cognitive and behavioral educational models.


Eligibility criteria:
inclusion criteria * patients at high-risk for an acute myocardial infarction, including any 2 of these risk factors: males age \> 45; females age \>55; family history of premature coronary heart disease (chd); current cigarette smoker; hypertension; or elevated total cholesterol with low hdl and/or high ldl. or have: * active angina (chest pain due to coronary heart disease) * history of coronary heart disease according to the treating physician * past history of myocardial infarction documented by electrocardiogram or arteriography * diabetes mellitus * renal dialysis exclusion criteria * hospitalization within previous 4 weeks * persons living in a home with previously enrolled patients * patients disoriented to person, place, or time at onset of study

Keywords: acute myocardial infarction diabetes mellitus renal dialysis heart attack coronary heart disease
the ham infliximab study

Conditions: HTLV-I-associated Myelopathy

Summary: an open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' htlv-i-associated myelopathy/tropical spastic paraparesis (ham/tsp). eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months. following 2 baseline assessments including magnetic resonance imaging (mri) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (csf) participants will be treated with a total of 7 infusions of the anti-tnf-alpha antibody infliximab over a period of 48 weeks. after the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. study assessments will be clinical, virological, immunological and radiological. mris of the spinal cord will be obtained at weeks 12 and 72. csf will be examined, on therapy, at week 12.


Eligibility criteria:
inclusion criteria: * are able to give informed consent * are 16 years or older * have 'definite' ham/tsp according to the criteria of "definite ham/tsp" agreed in belem 200361 * have early or progressing disease as defined here: * "early ham/tsp": patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (bladder symptoms if the original and only presenting symptoms as assessed by history are not included) * "progressing ham/tsp" * new or worsening motor symptoms in a patient with definite ham of \> 2 years duration within the last 3 months exclusion criteria: * hepatitis b or hepatitis c infection * hiv infection * overt sepsis, abscesses or opportunistic infections * active tb (untreated or on treatment) * strongyloides stercoralis (untreated) * known hypersensitivity to inflixmab, other murine proteins or to any of the excipients * malignancy * moderate or severe heart failure (nyha class iii/iv) * pregnancy or breastfeeding * unhealed surgical wounds * planned impending surgery - treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory * current immunosuppressive or immunomodulatory therapy

Keywords: ham/tsp htlv-i