Kornimate/medical-research-clean huggingface dataset:
study of the activity of pd-1 inhibitors in metastatic uveal melanoma

Conditions: Uveal Melanoma

Summary: study of the activity of pd-1 inhibitors in metastatic uveal melanoma

the aim of the research is to study the activity of pd-1 inhibitors in patients with metastatic uveal melanoma and treated by nivolumab and pembrolizumab. these molecules have already received the authorities approvals. the data collected will be crucial for the understanding of the mechanism of pd-1 inhibitors and also for the futures studies.

Eligibility criteria:
inclusion criteria: * patients with metastatic uveal melanoma * patients who received at least once injection of nivolumab or pembrolizumab in the case of the disease's treatment exclusion criteria: * antecedent of another evolutionary tumor pathology
high body mass index and severity of coronavirus

Conditions: COVID-19 Pneumonia

Summary: a cohort study included 114 adult patients with confirmed covid-19 were categorized by bmi levels on admission: overweight (25-29.9 kg/m2), and obesity (four categories: 30-34.9 kg/m2, 35-39.9 kg/m2, 40-44.9 kg/m2, and ≥45 kg/m2).


Eligibility criteria:
inclusion criteria: * patients older than 18 years * confirmed covuid 19 infection * body mass index more than 25kg/m2 exclusion criteria: -
unilateral meniere disease: can double dose gadolinium and delayed imaging make the diagnosis?

Conditions: Meniere Disease

Summary: the purpose of this research study is to see if magnetic resonance imaging (mri) with a double dose of contrast, or dye, and delayed imaging with mri can help to diagnose meniere disease.

meniere's disease (md) is a medical condition causing attacks of vertigo, ringing in the ears, hearing loss and often a fullness in the ear. currently there is no definitive test to diagnose the problem. it is believed to be caused by inner ear abnormalities, specifically of an over-collection of lymphatic fluid.the goal of this trial is to determine if an mri with double dose of iv gadolinium can be diagnostic.

Eligibility criteria:
inclusion criteria: * diagnosis of unilateral meniere disease (md) per the committee on hearing and equilibrium of the american academy of otolaryngology-head and neck surgery (aao-hns) * glomerular filtration rate (gfr) \> 90 mls/min/1.73 m2 * creatinine (cr) level serum \< 1.6 mg/dl exclusion criteria: * age \< 18 years * diagnosis of bilateral md * history of prior temporal bone surgery * history of cochlear implant placement * pacemaker, cardiac implantable electronic device, shrapnel, aneurysm clips or other metal objects that are prohibited in the mr suite * gfr \< 90 mls/min/1.73m2 * cr level \> 1.6 mg/d * lack of iv access * contrast allergy to gadolinium agent * pregnancy * claustrophobia necessitating parenteral anxiolytics * patients who are unable to provide informed consent for themselves
sevice-learning in physiotherapy and heart transplantation and acute coronary syndrome

Conditions: Heart Transplantation

Summary: a service-learning programme in physiotherapy students will be performed. 30 physiotherapy students will be randomly assigned to an intervention group (n=16) or to a control group (n=16). intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. in addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics. the control group will have to perform a physiotherapy program without meeting real patients.

this study aims at determining the effect of a service-learning program on knowledge, ethical sensitivity and acquired transversal competences. on the other hand, we aim at evaluating the service performed, the skills acquired, the participation, the degree of participatory evaluation and the level of satisfaction of the intervention group. all variables will be measured with validated scales or questionnaires. both groups will have to describe the specific characteristics of the program, different phases of the process, types of exercises recommended, contraindications, safety ranges with respect to the intensity of the exercise, ways of calculating the intensity and self-control. likewise, they will have to defend the usefulness and duration of the final product through an oral presentation of the program to the patients themselves. finally, the possible doubts that should exist will be solved.

Eligibility criteria:
inclusion criteria: * physiotherapy students exclusion criteria: * prior courses on cardiac rehabilitation
comparison of technosphere® insulin versus technosphere powder (placebo) in insulin-naive subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: insulin-naive subjects with type 2 diabetes mellitus who are sub-optimally controlled on either maximum tolerated dose of metformin or maximum tolerated dose of metformin plus one or two other oral anti-diabetic medications will have either prandial technosphere® insulin or technosphere powder (placebo) added to their oral antidiabetic drugs.


Eligibility criteria:
inclusion criteria: * hba1c \> or = to 7.5% and \< or = to 10.0% * body mass index (bmi) \< or = to 45 kg/m2 * non smoker for at least 6 months before screening * clinical diagnosis of type 2 diabetes mellitus for more than 12 months * currently receiving as diabetes treatment only metformin or 2 or more oads and on stable doses for at least 3 months before enrollment * subjects receiving metformin must be on at least 1.5gm daily, or up to the maximum tolerated dose * subjects treated with a sulfonylurea must be on at least 50% of the total maximum approved dose for a given agent * subjects receiving a dpp-4 inhibitor must receive the maximum approved dose specific for that agent * metiglinide and alpha-glucoside inhibitors must be taken at the highest tolerated dose within the approved dose range * no previous or current treatment with insulin, except during an acute illness, gestational diabetes, or at time of initial diagnosis of diabetes * forced expiratory volume in one second (fev1) \> or = to 70% third national health and nutrition examination survey (nhanes iii) predicted * forced vital capacity (fvc) \> or = to 70% nhanes iii predicted * forced expiratory volume in one second as a percentage of forced vital capacity (fev1/fvc) \> or = to nhanes iii lower limit of normal (lln) exclusion criteria: * history of chronic obstructive pulmonary disease (copd), clinically proven asthma, or any other clinically important pulmonary disease (eg, pulmonary fibrosis) * any clinically significant radiological findings on screening chest x-ray * use of medications for asthma, copd, or any other chronic respiratory conditions * evidence of serious complications of diabetes (proliferative retinopathy, autonomic neuropathy with symptoms of gastroparesis or cardiac arrhythmia; sensory neuropathy that makes manipulation of the gen2c inhaler difficult) * renal disease or renal dysfunction * significant cardiovascular dysfunction or history thereof within 12 months of screening; serious arrhythmia, treatment with medications to control/treat arrhythmias; myocardial infarction; cardiac surgery; history of valvular heart disease * previous or current use of amiodarone * treatment with glucagon-like peptide-1 (glp-1) analogs, thiazolidinediones (tzd), or weight loss drugs (eg, sibutramine, orlistat) within 3 months of screening * history of pulmonary embolism or deep venous thrombosis in the 12 months before screening * history of recent blood transfusion (within previous 3 months) or diagnosis of hemoglobinopathies that may affect hba1c measurements
comparing of the gastrointestinal motility in irritable bowel syndrome (ibs) patients with healthy volunteers

Conditions: Irritable Bowel Syndrome

Summary: the hypothesis of the study is that the motility of the small intestine and the colon will alter according to the subtype of the irritable bowel syndrome (ibs) patient. ibs is currently classified into following subtypes: * diarrhoea-ibs (ibs-d) * constipation-ibs (ibs-c) * mixed-ibs (ibs-m) * unsubtyped-ibs (ibs-u) according to the bristol scale. magnetic tracking system (mts) is a new minimal invasive technic that allows motility studies of the whole human gastrointestinal tract. the magnetic cylindrical pill (6x15mm) is swallowed at 9 am on day one. the recording is made until 4 pm and again from 8 am until 2 pm on day two. the patient is placed in a bed and will be supplied with standardized food and fluid. the magnetic tracking system consists of a 4 x 4 matrix of sensors positioned with respect to the anatomical reference points. before measurements, the matrix is calibrated by offsetting the earth's and environmental magnetic fields. during the experiment, the magnet coordinates are continuously monitored and transmitted to a computer for processing and storage. respiratory artifacts will be filtered out. digestive movements will then be classified as 1) non-propulsive or 2) propulsive and transformed into either trajectory or dynamic graphs of the digestive motility. the magnetic tracking system has the advantage from both radiographic and scintigraphic methods of conducting the tests without any radiation exposure to the patient. preliminary studies have shown good concordance between the transit measured with the magnet and radiographic transit times. the investigators wish to use this method, mts, to compare the motility of the small intestine and the colon in patients with ibs-d and ibs-c as well as to compare these to groups to mts done on healthy volunteers under the same conditions as the ibs patients.

a mts study on healthy volunteers is all ready done under the same conditions as described abow in denmark. this study has projectid 20080037 and is approved by the danish dataprotection agency as well as the regional committee on biomedical research ethics.

Eligibility criteria:
inclusion criteria: * patients aged over 18. * patients who are diagnosed with ibs according to the rome iii criteria. * a total symptom score in gsrs-ibs at a minimum of 40 points. * patients who are psychologically stable and suitable for observation and able to provide informed consent. exclusion criteria: * overt bowel diseases including inflammatory bowel disease. * pregnant or breast feeding. * patients who are considered unable to follow the planned programme of the study, including mental illness or physiological instability. * patients who are on medication with known influence on gastrointestinal motility including those for thyroid disease, diabetes mellitus, celiac disease and neurological disease.

Keywords: irritable bowel syndrome irritable bowel syndrome subgroups motility
opioid free anesthesia in breast cancer surgery

Conditions: Opioid Free Anesthesia

Summary: a comparison of incidences of postoperative nausea and vomiting (ponv) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

breast cancer is one of the most common oncologic diagnosis in women. surgery is traditionally performed under general anesthesia with opioid-based analgesia. it is associated with higher incidences of ponv, more severe acute postoperative pain and increased incidences of chronic pain. the possibility of higher risk of metastasis has also been reported. the purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

Eligibility criteria:
inclusion criteria: 1. first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes; 2. asa physical statue i-ii; exclusion criteria: 1. chronic pain and opioid administration history; 2. allergy to local anesthetics or nsaids; 3. coagulation disorders; 4. local infection at regional block site; 5. unable to comply to study protocol schedule for logistic or other reasons; 6. refusal to participate to the study； 7. breast reconstruction with implants or latissimus dorsi flap
second generation dicart prototype validation

Conditions: Acute Circulatory Failure; Shock

Summary: capillary refill time (crt) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock. crt is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation. the investigator hypothesizes that crt measurement with second generation dicart prototype will be well correlated with clinical measurement.


Eligibility criteria:
inclusion criteria: -\>18 years old * acute circulatory failure * written informed consent given by patient or its relatives exclusion criteria: * pregnant women, breastfeeding women, childbearing age women without oral contraception * cutaneous lesion at measurement site * patient under legal protection * patient already included in another interventional clinical trial

Keywords: acute circulatory failure shock capillary refill time (crt) prognosis diagnostic evaluation
weight bath traction in chronic low back pain

Conditions: Low Back Pain

Summary: it is typical of chronic low back pain that, after the first painful episode, is repeated at 44-78% of patients. for acute lumbar pain, approx. 10-15% of them are converted into chronic. conservative treatments are few studies done in the traction therapy. a large number of multicenter trials did not evaluate the effectiveness of underwater traction therapy.

goals are the followings: 1. is the beneficial effect of a weight bath comparable to a non-treated control group with respect to clinical parameters? 2. how much does the quality of life change in an initial state and how much is it in comparison with the control group?

Eligibility criteria:
inclusion criteria: * at least 12 weeks of non-specific lymphatic pain, * the pain sensitivity of the paravertebral muscle and the painful movement of the lumbar spine can be observed, which can be characterized by segmental motion, segmental instability or other reasons * radiographically confirmed spondylosis, discopathy, and spondylarthrosis within one year. * back pain at least 30mm (100mm visualis analogue scale). * patients could not received systemic or locally administered steroid therapy, physiotherapy or they get balneotherapy in the last 2 months p- atient consent form signed before the start of test exclusion criteria: * the exclusion criteria included previous lumbar spine surgery, * progressive neurologic loss, * pregnancy, * (umbilical, hiatal, inguinal) hernia, * malignities, * infectious diseases, * inflammatory pathologies, * severe pulmonary and cardiovascular diseases, * uncontrolled- hypertension, * mental disorders, * incontinence, * acute lower back pain; * organic neurological symptoms associated with the lower back; * pain in the background of osteoporosis or other causes of vertebral compression is likely * lack of complience, * pain due to inflammatory spinal disease; * spondylolisthesis (which is not greater than 25% of vertebral skeleton compared to adjacent vertebrae)

Keywords: balneotherapy chronic low back pain controlled randomized trial weight bath traction follow-up
neurobiological and immunological mechanisms of dyspnea in als (biopnea)

Conditions: Shortness of Breath; Dyspnea; Amyotrophic Lateral Sclerosis

Summary: dyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. amyotrophic lateral sclerosis (als) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, sma). the perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in als; relieving dyspnea by noninvasive ventilation (niv) is associated with decreased pain thresholds. otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers. the objectives are to evaluate the cytokines and endorphins rates variations after initiation of niv in als patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea. the investigators will perform a prospective, experimental study, including 30 als patients. dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (acth, endorphin, neuropeptide p, bdnf, il1, il6, il8, il10, tnf), will be measured during spontaneous breathing and during niv at different times after initiation. the investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by niv. this work could lead to the development of new treatments for dyspnea.


Eligibility criteria:
inclusion criteria: - patients with chronic respiratory failure with diaphragmatic dysfunction linked to amyotrophic lateral sclerosis and requiring long-term niv exclusion criteria: * other respiratory disease (copd, asthma, obstructive sleep apnea) * alcohol or psychotropic drug the lasts 24 hours * cognitive impairment * smoking \> 10 pa * exacerbation or infection 6 weeks earlier * endstage of illness * chronic or acute pain (vas \> 3)
the diagnostic performance of 24-hour urinary aldosterone for primary aldosteronism

Conditions: Primary Aldosteronism; Hypertension

Summary: this is an observational study to define the cut-off value of 24-hour urinary aldosterone for diagnosing primary aldosteronism in hypertensive patients in our center. plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. aldosterone secretion is not constant and may be subject to diurnal variation. as such one-off testing of arr, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. the value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. this study will help establish the positivity rates of 24-hour urine aldosterone, and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation. previous studies reported that primary aldosteronism is associated with a higher risk of cv complications and a higher prevalence of target organ damage. also, previous studies reported on the association of echocardiographic parameters with circulating or urinary aldosterone. therefore, we intent to investigate the independent associations of different target organ damage with the urinary excretion of aldosterone.


Eligibility criteria:
inclusion criteria: 1. aged 18 years and above. 2. meets the 2018 chinese guidelines for prevention and treatment of hypertension for a diagnosis of hypertension with an age of onset of hypertension between 18-80 years. 3. meets the endocrine society clinical practice guidelines for a diagnosis of primary aldosteronism with an age of onset of hypertension between 18-80 years. exclusion criteria: 1. other causes of secondary hypertension, including renal hypertension, renovascular hypertension and adrenal hypertension (i.e., pheochromocytoma and cushing syndrome). 2. urine output less than 400ml per day. 3. severe renal insufficiency with a glomerular filtration rate \< 60 ml/min/1.73 m2. 4. lack of 24-h urinary aldosterone data.
using transcranial magnetic stimulation (tms) to understand hallucinations in schizophrenia

Conditions: Schizophrenia; Schizo Affective Disorder

Summary: this study uses a noninvasive technique called transcranial magnetic stimulation (tms) to study how hallucinations work in schizophrenia. tms is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. the magnetic field is produced by a coil that is held next to the scalp. in this study the investigators will be stimulating the brain to learn more about how tms might improve these symptoms of schizophrenia.

this study tests the hypothesis that hallucinations in schizophrenia are mediated by network pathophysiology, and that network pathophysiology can be quantified by the functional connectivity of a cerebellar-thalamo-cortical circuit. to accomplish this, participants will be recruited who are diagnosed with schizophrenia or schizoaffective disorder who experience auditory hallucinations. participants will undergo an initial screening session to complete informed consent and undergo baseline assessments of schizophrenia symptom severity. these assessments include reporter-based measures such as the positive and negative syndrome scale (panss). participants will then undergo an mri scan that includes structural and resting-state functional magnetic resonance imaging (rsfmri). these rsfmri imagines will be used to isolate individual resting state networks for targeting of rtms modulation. participants will then undergo five days of twice daily rtms sessions. one week after the last rtms session, participants will undergo follow-up mri imaging and the same study assessments.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder exclusion criteria: * substance use disorder in past 3 months * ambidexterity * contraindications for tms or mri including : * history of neurological disorder * history of head trauma resulting in loss of consciousness * history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy * metal in brain or skull * implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt * claustrophobic in mri
a multiple ascending dose study of etc-1002 in subjects with mild dyslipidemia

Conditions: Mild Dyslipidemia

Summary: this phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of etc-1002 given to subjects with mild dyslipidemia.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ecg, and clinical laboratory measurements * fasting low density lipoprotein-cholesterol (ldl-c) of 100-160 mg/dl * fasting triglycerides (tg) of 100-350 mg/dl (cohort 5 only) * body mass index (bmi) of 18-32 kg/m2 (cohort 1 to 4 only) or 18-36 (cohort 5 only) and body weight \>50 kg exclusion criteria: * clinically significant disease that requires a physician's care and/or would interfere with study evaluations * alanine aminotransferase (alt) or aspartate amino transferase (ast) \>1.2 x uln; serum creatinine \>uln; hemoglobin \<12.0 g/dl; other clinical lab tests (with the exception of alt, ast, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the investigator to be clinically significant * use of tobacco or tobacco products * use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin \>500 mg/day or fish oil which will not have been used for 3 months prior to randomization * other exclusion criteria apply