Kornimate/medical-research-clean huggingface dataset:
spectro-irm and evaluation response to prostatic radiotherapy

Conditions: Prostate Cancer

Summary: context: prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in european and north-american men. after external radiotherapy or brachytherapy, the prostate specific antigen (psa) value is often fluctuating and psa nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. moreover, psa bounces and blips render patients and physicians very anxious about any possibility of a relapse. in this context, biomarkers that could predict the response to radiation earlier than psa for patients with prostate cancer appear long overdue. magnetic resonance spectroscopy at 3 tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as choline, creatine, polyamines and citrate within the prostate gland. objectives: the investigators are conducting a french prospective study on the evaluation of the response to irradiation with mr spectroscopy (eris). their purpose is to monitor the early response of radiation with 3d mr spectroscopy during the first year after completion of radiation and its impact on biochemical control. therefore, the eris trial aims to investigate whether or not there could be a correlation between the time course of psa and that of choline and citrate.


Eligibility criteria:
inclusion criteria: 1. patients with a biopsy-proven prostatic adenocarcinoma 2. gleason score between 4 and 10 3. maximal baseline psa \< 50 ng/ml 4. age over or = to 18 yr 5. exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy 6. written informed consent from the patient exclusion criteria: 1. lymph-node metastases 2. bone metastases 3. maximal baseline psa ≥ 50 ng/ml 4. prior radical prostatectomy 5. contra-indications for mri (pace-maker, hip prothesis...)

Keywords: localized
bioequivalence of two liraglutide formulations in healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).


Eligibility criteria:
inclusion criteria: * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs and blood and urinary laboratory assessments * bmi (body mass index) of 18.0-27.0 kg/m\^2, both inclusive exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator * impaired renal function * any clinically significant abnormal ecg, as judged by the investigator * active hepatitis b and/or active hepatitis c * positive human immunodeficiency virus (hiv) antibodies * known or suspected allergy to trial product(s) or related products * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures * history of alcoholism or drug abuse, or positive results in alcohol or drug screens * smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products * habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator * excessive consumption of a diet deviating from a normal diet as judged by the investigator
a prospective monocentric study to assess the concordance of lung mri compared to chest ct scan to assess the extent and severity of bronchial and parenchymal pulmonary lesions in adult patients with primary immune deficiency (pid) .

Conditions: Primary Immune Deficiency

Summary: currently, there is no official recommendations for the respiratory surveillance of patients with pid.however, it is recommended to perform a chest ct scan each 5 years or before any significant therapeutic change. the methods of surveillance need to meet two contradictory imperatives: * monitor frequently enough not to diagnose with delay an aggravation of bronchiectasis or interstitial pneumonitis, an infectious complication by a slowly growing pathogen such as a non-tuberculous mycobacterium, or lymphoid proliferation. * do not expose these often young patients to significant irradiation by a considerable number of scans during their life. in addition, some patients with pid have increased radiosensitivity without a safe irradiation threshold having been determined. to make thoses requirements effective, the solution is to combine radiological monitoring and absence of irradiation. therefore, it makes sense to study whether chest scans can be replaced by mri, non-irradiating imaging. but the question that needs to be answered is whether the information provided by the chest mri is not inferior to that provided by the scanner. the objective of this study is to assess the ability of mri performed with ultrashort echo time to analyze the extent and severity of bronchial and pulmonary parenchymal lesions during the follow-up of patients with primary immunodeficiency, comparing them to those of the chest ct scan.


Eligibility criteria:
inclusion criteria: * patients aged 18 or over * adult patients with pid * patients who have performed efr (functional respiratory tests) within 6 months * patients who have signed a consent form * patients affiliated with a health insurance plan. exclusion criteria: * pregnant woman * contraindications to mri: * patients with magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), * patients with intraocular metal or in the brain (aneurysm clip), * patients with prostheses in the thoracic position and contraindicated for mri examination * claustrophobic patients. * to be deprived of liberty or under guardianship.

Keywords: primary immune deficiency mri chest ct scan
gemcitabine, docetaxel, and cetuximab in patients with unresectable advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: this purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (nsclc), in combination with a novel agent cetuximab.

upon determination of eligibility all patients will receive: * docetaxel + gemcitabine + cetuximab

Eligibility criteria:
inclusion criteria: to be included in the study, you must meet the following criteria: * 18 years of age or older * non-small cell lung cancer confirmed by biopsy * unresectable stage iii or iv disease * measurable disease * must not have received any prior chemotherapy for lung cancer * able to perform activities of daily living without considerable assistance * adequate bone marrow, kidney, and liver function * signed informed consent exclusion criteria: you cannot participate in the study if any of the following apply to you: * history of serious heart disease within six months prior to study entry * prior treatment with agents that target the egfr pathway * history of any other uncontrolled or significant disease 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. you can then decide if you wish to participate.

Keywords: lung cancer
inhaled nitric oxide in pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the purpose of the study is to determine if inhaled nitric oxide, a potent and selective pulmonary vasodilator, is beneficial in patients with acute pulmonary embolism causing increased right ventricular afterload.

the early phase of severe pulmonary embolism is associated with high mortality. right ventricular failure induced by the increase in right ventricular afterload is the final cause of deterioration leading to circulatory failure in patients who die from severe pulmonary embolism. therefore, reduction of right ventricular afterload remains the central therapeutic strategy. in acute pulmonary embolism, the increase in pulmonary vascular resistance is caused by reduction in the cross-sectional area of the pulmonary vascular bed from obstructing emboli. pulmonary arterial constriction further increases pulmonary vascular resistance, whereby vasoactive humoral factors may be contributing, which are released from activated platelets accumulating at the site of the clot. consequently, administration of vasodilators of the pulmonary circulation may be regarded as a therapeutic option to antagonize increased pulmonary vasoconstriction or compensate for impaired vasodilation. inhaled nitric oxide (no) acts as a powerful selective pulmonary vasodilator. the aim of the study is to determine, if short-term inhalation of no is beneficial in respiratory compromised patients with right ventricular dysfunction after acute pulmonary embolism.

Eligibility criteria:
inclusion criteria: * patients with acute pulmonary embolism within 24 hours after onset of symptoms. * patients with hypoxaemia not present before pulmonary embolism and acute right ventricular dysfunction. exclusion criteria: * age \< 18 years. * chronic lung disease, left heart failure, suspected or documented intracranial bleeding. * pregnancy, methaemoglobinaemia. * patients who previously needed thrombolysis or surgical embolectomy. * negative d-dimer test.

Keywords: pulmonary embolism inhaled nitric oxide
intravenous tapentadol in post-bunionectomy pain

Conditions: Bunion; Pain

Summary: the purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol iv in an adult population with moderate to severe pain following bunionectomy.


Eligibility criteria:
inclusion criteria: * scheduled to undergo primary unilateral first metatarsal bunionectomy * female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active * qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (nrs). exclusion criteria: * history of malignancy within the past 2 years * current or history of alcohol or drug abuse. * clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately * history of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures * severely impaired renal function * moderately or severely impaired hepatic function * contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients * use of prohibited concomitant medication, or not allowed use of restricted concomitant medication

Keywords: bunionectomy postsurgical pain acute pain
nebulized dexmedetomidine versus neostigmine/atropine in postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: in our study, we will compare a new route of nebulization for effectiveness between dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural puncture headache (pdph) after cesarean section.

a written informed consent will be taken from the patients. the study will involve female adults (age 18-40years) of american society of anesthesiologists (asa) i-ii who are listed for elective cesarean section under spinal anesthesia and suffer from postoperative postdural puncture headache (pdph). patients will be assigned randomly to three groups (30 subjects each) after pdph diagnosis was established. first 90 patients developed pdph will be assessed for study eligibility. group d (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 ml saline) twice daily for three days. group n (patients will receive nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. group s (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of postdural puncture headache (pdph) after elective cesarean section under spinal anesthesia. exclusion criteria: * hypersensitivity of dexmedetomidine, neostigmine or atropine * overactive thyroid gland * myasthenia gravis * closed angle glaucoma * high blood pressure and coronary artery disease. * withdrawal of consent
cmr right ventricular contractile reserve following lung resection

Conditions: Lung Cancer; Surgery; Anesthesia

Summary: feasibility study investigating cmr dobutamine stress testing before and after lung resection

we hypothesise that following lung resection, 1. the subtle decrease in rv function and increase in afterload we have demonstrated at rest is associated with a marked impairment of rv function on exercise, termed impaired rv contractile reserve (rvcreserve), 2. impaired rvcreserve is associated with impaired functional capacity . in this study we aim to assess the feasibility of dobutamine stress cardiovascular magnetic resonance (cmr) scanning to assess rvcreserve pre- and post-operatively in patients undergoing lung resection. additionally, we hypothesise that one lung ventilation (with and without lung resection) is associated with biomarker evidence of rv injury.we will perform peri-operative cardiac biomarkers to differentiate between the contribution of major surgery (gastrectomy, lung resection and oesophagectomy), one lung ventilation (lung resection and oesophagectomy) and lung resection on rv injury.

Eligibility criteria:
inclusion criteria: * 1) provision of informed consent 2) age \>16 years 3) planned elective 1. lobectomy lung resection or 2. oesophagectomy surgery with one lung ventilation or 3. gastrectomy exclusion criteria: 1. pregnancy 2. on-going participation in any investigational research which could undermine the scientific basis of the study 3. atrial fibrillation at baseline 4. any contraindication to a. cmr, i. cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. aneurysm clips iii. metal injuries to the eye iv. loose metal in a part of the body b. dobutamine stress testing as per the society for cardiovascular magnetic resonance64 i. severe systemic arterial hypertension (≥220/120 mmhg) ii. unstable angina pectoris iii. severe aortic valve stenosis (peak aortic valve gradient \>60mmhg or aortic valve area \< 1cm2) iv. complex cardiac arrhythmias including uncontrolled atrial fibrillation v. hypertrophic obstructive cardiomyopathy vi. myocarditis, endocarditis, or pericarditis vii. uncontrolled heart failure 5. lung resection specific 1. wedge, segmental or sub-lobar lung resection 2. pneumonectomy 3. isolated right middle lobectomy -
comparison of acute tart cherry supplement formulation and dose on inflammation and oxidative capacity

Conditions: Inflammation; Oxidative Stress

Summary: a comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.

participants will be randomly allocated to a group: one tart cherry capsule daily, two tart cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo. participants will arrive to the lab at 8 am after an overnight fast of 10 hours. they will provide a blood sample and then ingest their study treatment. participants will stay in the lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for another blood draw. at this time if they are in a twice daily group they will receive their second treatment for the day. all participants will come back to the lab 24 hours later where they will give a blood sample and receive their next treatment. if they are in the twice daily group they will be provided with their next dose and given instructions to consume it in 8 hours. participants will arrive 24 hours later for a final blood draw with no supplementation. blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours post-ingestion. samples will be analyzed for plasma oxygen radical absorbance capacity (orac), uric acid (ua), and c-reactive protein (crp).

Eligibility criteria:
inclusion criteria: * free of cardiovascular, metabolic and inflammatory conditions * non-smokers * no known allergy to cherries or cherry juice * not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.). exclusion criteria: * quit smoking less than one year ago. * currently being treated for arthritis or an inflammatory condition. * currently being treated for uncontrolled cardiovascular disease, high blood pressure, diabetes, fibromyalgia, or irritable bowel syndrome. * pregnant. * regularly consume cherries or are allergic to cherries or dairy. * currently use anti-inflammatory medications, * have used corticosteroids in the last two months.
treatment of advanced hodgkin's disease (stages iib-iii-iv)

Conditions: Advanced Hodgkin Disease

Summary: the purpose of this study is to compare the toxicities of the coppebvcad vs beacopp vs abvd regimens.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of hodgkin disease * clinical stage iib, iii, iv * no prior treatment for hodgkin disease or other malignancy * age 18-65 year * good cardiac, pulmunar, renal and hepatic function * performance status 0-3 (karnofsky 100- 40) * written informed consent exclusion criteria: * hiv positivity * large cell, anaplastic, cd30+ lymphoma
deep sclerectomy versus trabeculectomy in normal tension glaucoma

Conditions: Normal Tension Glaucoma

Summary: the purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (iop) as trabeculectomy in patients with normal tension glaucoma.

subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. all patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

Eligibility criteria:
inclusion criteria: * signed informed consent * normal tension glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (oct) and possible equivalent visual field defects, iop never more than 21 mmhg, and open anterior chamber angle * glaucoma unstable with current medication assessed by a glaucoma specialist exclusion criteria: * secondary glaucoma e.g. due to previous injury or uveitis * exfoliation syndrome * pigment dispersion syndrome * previous transscleral or endoscopic cyclophotocoagulation * previous other glaucoma surgery * previous retinal detachment * previous intraocular surgery like vitrectomy and other retinal surgery * wet age-related macular degeneration * diabetic retonopathy * previous corneal transplant or previous refractive surgery * fuchs' dystrophy and other abnormalities compromising corneal clarity like scars * the patient does not want to participate in the study * the patient does not speak finnish, swedish or english * dementia * only eye with vision worse than 20/200 or loss of central visual field
characterizing hemorrhage in acute spinal cord injury with mri

Conditions: Traumatic Spinal Cord Haemorrhage

Summary: the study is designed to determine whether hemorrhage within the injured spinal cord is influenced by mean arterial pressure (map) augmentation with vasopressors and by venous thromboembolism (vte) prophylaxis with anticoagulants in the first two weeks following a traumatic spinal cord injury (tsci).

this will be a single-center prospective observational study of patients with an acute cervical traumatic spinal cord injury

Eligibility criteria:
inclusion criteria: * acute tsci injury involving bony spinal levels between c0 and t1 * baseline asia impairment scale (ais) grade of a, b, or c * admission to study site within 24 hours of injury * male or female age 19 or older * able and willing to provide informed consent exclusion criteria: * pathological fracture due to metabolic condition or neoplasia * spinal cord injury due to infection * presence of pacemaker, aneurysm clip or other device which is a contraindication to mri * bmi \> 40 and unable to fit within the mri scanner * multiple life threatening injuries (iss \>16) that make transport to mri not in the patient's best interest * any condition that, at the time of admission, prevents a complete isncsci assessment from being performed

Keywords: vasopressors magnetic resonance imaging
predictors of anticoagulation control on warfarin therapy

Conditions: Atrial Fibrillation; Deep Vein Thrombosis; Heart Valve Replacement

Summary: the goal of this research study is to develop better dosing of anticoagulation medication in both caucasian and african americans through analysis of various genetic factors.

this is a prospective cohort study among adult patients requiring warfarin therapy. patients presenting for anticoagulation will be identified at the start of therapy and followed throughout their course until they reach maintenance dose. we will then develop a dosing equation for warfarin using patient, environmental and genetic factors.

Eligibility criteria:
inclusion criteria: * all caucasians and african americans who are new to warfarin therapy exclusion criteria: * under 21 years of age * non caucasian * non african american * have an abnormal inr before warfarin or heparin therapy * unable to provide consent

Keywords: atrial fibrillation deep vein thrombosis anticoagulation warfarin coumadin
a trial of cognitive behavioral therapy in familial dysautonomia

Conditions: Dysthymia; Anxiety Disorders; Familial Dysautonomia; Paroxysmal Hypertension; Autosomal Recessive Disease

Summary: to determine the effect of cognitive behavioral therapy (cbt) in the severity of anxiety and depression in adult patients with familial dysautonomia. patients will be enrolled in an 8-week cbt program. all cbt sessions will be done either in person at the nyu dysautonomia center or over the phone to help accommodate disability and potential physical limitations of our patient population.

cognitive behavioral therapy (cbt), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function. patients will participate in eight forty-five minute sessions of cbt with a mental health therapist in order to help treat generalized anxiety disorder, anxiety disorder due to another medical condition (familial dysautonomia), major depressive disorder, persistent depressive disorder (dysthymia), substance/medication- induced depressive disorder, depressive disorder due to another medical condition.

Eligibility criteria:
inclusion criteria: * diagnosis of fd (genetically confirmed) * dsm-v criteria of major depressive disorder or anxiety disorder * stai score ≥ 25 or a phq-9 depression scale score ≥ 5 or greater * willing and able to complete 8 cbt sessions * maintain constant psychoactive medication through out study and no concurrent talk therapy from another therapist. exclusion criteria: * currently suicidal or having current suicidal ideations * currently under psychiatric treatment for depression or anxiety * have started any psychoactive medication within 3 months prior to screening

Keywords: familial dysautonomia