Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy and toripalimab followed by chemoradiotherapy for large-volume local advanced nsclc

Conditions: Local Advanced Non-small Cell Lung Cancer

Summary: this study is a phase ii study to evaluate the clinical efficacy and safety of toripalimab combined with chemoradiotherapy for large-volume local advanced non-small cell lung cancer

this study is a phase ii study to evaluate the clinical efficacy and safety of two cycles of induction toripalimab plus chemotherapy followed by definitive chemoradiotherapy and consolidation toripalimab therapy for large-volume, unresectable, locally advanced stage ii-iii non-small cell lung cancer ("large volume" is defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter).

Eligibility criteria:
inclusion criteria: 1. age 18-70 years; ecog score 0-2. 2. histologically or cytologically confirmed non-small cell lung cancer (nsclc). 3. unresectable stage ii-iii nsclc (according to ajcc 8th edition) with maximum tumor diameter t ≥ 5 cm in the primary tumor or minimum diameter n ≥ 2 cm in mediastinal metastatic lymph nodes. 4. no other previous anti-tumor history, at least 3 months of expected survival. 5. no serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. exclusion criteria: 1. pathologic type was adenocarcinoma with egfr gene mutation or alk gene rearrangement. 2. patients with other active malignancies within 5 years or at the same time. 3. active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, sarcoidosis syndrome, wegener' s syndrome). 4. history of allogeneic organ transplantation. 5. history of active primary immunodeficiency. 6. patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis b, hepatitis c, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. 7. women of child-bearing potential who are pregnant or breastfeeding. 8. allergic to research drug ingredients. 9. ongoing or prior use of immunosuppressive agents within 14 days prior to first dose 10. the investigator judged other situations not suitable for inclusion in this study.
head and neck melanoma; access to staging and surgical treatment

Conditions: Melanoma (Skin); Melanoma

Summary: melanoma is a serious type of skin cancer and is the 5th most common cancer in the united kingdom (uk). it can affect anywhere on the skin including on the head and neck. the cancer often is first noticed as an abnormal mole. treatment is by removing the cancer with surgery. early spread of the cancer can be found by testing nearby glands called lymph nodes. this operation is called a sentinel lymph node biopsy (slnb). if the cancer has spread then new treatments, such as immunotherapy, can be given to help the person live for longer. the sentinel lymph nodes are usually in the armpits or groin for melanoma on the body, arms or legs. for cancers in the head and neck the sentinel lymph nodes will usually be in the neck. for several reasons slnb in the neck is not offered in every hospital that manages patients with melanoma. the problem with this is that some patients who could benefit are not offered the new treatments that extend life because it is not known that their cancer has spread. in this study we aim to gather national data on the management of melanoma of the head and neck including variation in practice between different hospitals. we will use routinely collected anonymous data called 'hospital episode statistics' to look at who is offered slnb after melanoma of the head or neck, what treatments they have, if their melanoma comes back and how long they survive for. by doing this, we hope to identify whether slnb should be made available to everyone diagnosed with melanoma of the head and neck.


Eligibility criteria:
inclusion criteria: we will use recorded icd-10 codes to identify patients for the study. all patients over 18 years of age will be included in the study if they have been coded as: c43.0 malignant melanoma of lip c43.1 malignant melanoma of eyelid, including canthus c43.2 malignant melanoma of ear and external auricular canal c43.3 malignant melanoma of other and unspecified parts of face c43.4 malignant melanoma of scalp and neck c43.5 malignant melanoma of trunk c43.6 malignant melanoma of upper limb, including shoulder c43.7 malignant melanoma of lower limb, including hip exclusion criteria: n/a
monitoring the antiphospholipid syndrome:toxicity of drugs (apstox)

Conditions: Antiphospholipid Syndrome; Immune Disease; Adverse Drug Event; Drug Toxicity

Summary: several drugs and chemotherapies seem to have an impact on the immune system. this study investigates reports of immune toxicities such as antiphospholipid syndrome, including the international classification of disease icd-10 for treatments in the world health organization (who) global individual case safety report (icsr) database (vigibase).

several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents. this study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome. a causality assessment according to the who-umc (world health organization - uppsala monitoring center) is systematically applied.

Eligibility criteria:
inclusion criteria: - case reported in the who's pharmacovigilance database till 01/06/2019 exclusion criteria: * chronology not compatible between the drug and the toxicity
carotid endarterectomy versus carotid artery stenting in asymptomatic patients

Conditions: Carotid Stenosis

Summary: the trial randomise patients with asymptomatic carotid artery narrowing in whom prompt physical intervention is thought to be needed, but there there is still substantial uncertainty shared by patient and doctor about whether surgery or stenting is the more appropriate choice. the study is looking at immediate risks (within one month)and at long term benefits


Eligibility criteria:
inclusion criteria: * carotid artery stenosis detectable by duplex ultrasound, with no ipsilateral carotid territory symptoms(or none for some months) and no previous procedure done on it, which might well need procedural treatment now with cea or cas. * already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, cabg) * patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) * investigations show that both procedures (cea and cas) appear to be practicable and appropriate * some type of angiography (eg, mra or cta) has already been done that has shown that cea and cas would both be anatomically practicable. * doctor and patient both substantially uncertain about whether to treat with cea or cas, and the doctor sees no clear indication/contra-indication for either procedure exclusion criteria: * small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer) * unsuitable for one or other procedure (eg, stenosis at carotid siphon that is inaccessible for cea, or complex vasculature below the stenosis that would hinder cas, or patient unfit for major surgery)

Keywords: carotid stenosis cea cas stenting
ambroxol spray sore throat study

Conditions: Pharyngitis; Pain

Summary: the development of a new ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase ii study to be conducted in order to select the most appropriate dose for pain relief.


Eligibility criteria:
inclusion criteria: 1. sore throat due to acute pharyngitis (not more than 72 hours); 2. score of 6 or greater on an 11-point pain intensity numerical rating scale; 3. willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later. 4. willing to take nothing by mouth except study medication for three hours following the first intake of study medication. patients must also not smoke during this time period. exclusion criteria: 1. known allergy to and/or hypersensitivity to ambroxol, sorbitol, or acetaminophen; 2. patients with drug dependence and/or alcohol abuse; 3. use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours; 4. use of any analgesic/anti-pyretic within last 4 hours; 5. use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours; 6. use of an antibiotic for an acute illness within last 24 hours; 7. use of inhaled steroids or beta-agonists on a continuous basis during the last week; 8. use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days 9. any sign of mouth-breathing due to nasal congestion; 10. cough that causes throat discomfort; 11. active pulmonary disease such as bronchopneumonia; 12. pregnant, lactating or breastfeeding women, 13. any medical or psychiatric condition which, in the opinion of the investigator, could increase the risks associated with participation in an investigational study or affect compliance with the protocol. 14. patients who have previously enrolled in this study
psychiatric and cognitive assessment of adult patients with hearing impairment

Conditions: Hearing Loss

Summary: 1. assess the impact of hearing impairment on cognition 2. evaluate the impact of hearing impairment on mental health 3. evaluate the impact of hearing impairment on quality of life 4. assess the relation between hearing loss and psychiatric disorder

hearing impairment is described as the partial or total loss of hearing ability. on the basis of the severity of the problem hearing impairment can be classified as mild, moderate, severe and profound. age related hearing impairment is a very common disorder in older adulthood. it is considered as third most prevalent chronic health condition in people over 65 years of age. hearing impairment in old age typically stems from some pathological changes inside the ear which are related to aging, it may lead to the impairment of low to high frequency hearing. this problem comes up with greater difficulty in listening process that significantly impairs person's ability to communicate with others, which in turn is a serious concern related to the mental health of individual. it has been reported that adults with hearing loss tend to exhibit more symptoms of depression, anxiety, psychological distress, and emotional sensitivity as compared to people with normal hearing. hearing loss poses a serious risk to the mental well-being and overall quality of life in older adults. people may experience diminished self-esteem that in effect leads to the poor mental health and decline in psychological well-being. also, recent studies have demonstrated independent associations of hearing loss with incident dementia. in egypt such studies are lacking so investigators try to assess the impact of hearing loss on psychiatry, cognition and quality of life by psychiatric interview, psychometric assessment , cognition assessment and quality of life assessment. the aim is to evaluate the impact of hearing impairment on the above domains in egypt

Eligibility criteria:
inclusion criteria: 1. all patients diagnosed with hearing impairment 2. age : 18 years and above 3. gender: both sexes are included 4. willing to participate in the study 5. willing and able to provide informed consent exclusion criteria: 1. patients with intellectual disabilities 2. patient with previous psychiatric and cognitive disorders 3. patients with neurological diseases that affect hearing 4. patients with history of chronic/ significant medical condition
the effect of different sound stimulation on the residual inhibition of tinnitus

Conditions: Tinnitus

Summary: the purpose of this study is to compare the effect of different sound stimulation on the residual inhibition of tinnitus. in this study, tinnitus patients will be assigned to a cross-over intervention of tinnitus frequency-centered narrowband noise stimulation and low frequency burst sound stimulation.

residual inhibition (ri) is a common phenomenon of short-term suppression of tinnitus, which refers to the suppression or reduction of tinnitus even after the end of the masking sound. ri is instructive in selecting tinnitus patients suitable for sound therapy. however, the effect of different sound stimulation on the ri of tinnitus remains unclear. in this study, we hypothesized that low frequency burst sound stimulation is superior to tinnitus frequency-centered narrowband noise stimulation for tinnitus relief, as measured by subjective tinnitus loudness changes. meanwhile, the neurophysiological mechanisms were further explored by eeg and fnirs.

Eligibility criteria:
inclusion criteria: 1. adults aged between 18 and 70 years old. 2. subjective tinnitus. 3. unilateral tinnitus or bilateral tinnitus of the same pitch. 4. can communicate in mandarin or with the help of an agent. 5. 50 db hl or less on the average pure tone threshold (0.5, 1, 2khz) of the worse ear. 6. subjects or their legal representatives can understand the purpose of the study, voluntarily participate and can cooperate in completing the experiment according to the instructions, and sign the informed consent form. exclusion criteria: 1. vascular pulsatile tinnitus or objective tinnitus. 2. bilateral tinnitus with different tones. 3. patients with significant health problems that interfere with or prevent participation in the experiment or cooperation with follow-up visits. 4. patients with severe auditory hypersensitivity and psychiatric disorders such as severe anxiety and depression; 5. currently participating in other research programs that may affect tinnitus. 6. patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Keywords: tinnitus residual inhibition
a smartphone intervention with telemedicine support for management of post-traumatic stress disorder: a randomized trial

Conditions: PostTraumatic Stress Disorder

Summary: this study tests whether people receiving clinician support to use a mobile application on their smartphone can manage their post-traumatic stress disorder (ptsd) symptoms better than those who do not. half of the participants will receive the clinician supported smartphone application intervention and the other half will remain on the waiting list.


Eligibility criteria:
inclusion criteria: * on the waiting list for the ontario shores traumatic stress clinic; * score ≥ 31 on the pcl-5 * have access to a smartphone or tablet to which they are willing to download the app. exclusion criteria: * active suicidal ideation
endothelial microparticles: a novel marker of vascular dysfunction

Conditions: Chronic Kidney Disease

Summary: the primary hypothesis of this proposal is that chronic kidney disease (ckd) and treatment with calcineurin inhibitors (cnis) are each associated with the release of endothelial microparticles into the plasma.

the primary hypothesis of this proposal is that chronic kidney disease (ckd) and treatment with calcineurin inhibitors (cnis) are each associated with the release of endothelial microparticles into the plasma. these injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. to test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage iii and iv ckd not receiving cni therapy, and individuals with stage iii and iv ckd post kidney transplantation receiving a cni. the goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).

Eligibility criteria:
inclusion criteria: for healthy controls: * bmi less than 40 kg/m\^2 * able to give informed consent for stage iii or iv ckd patients: * bmi less than 40 kg/m\^2 * able to give informed consent * an estimated glomerular-filtration rate (gfr) of 20-60 ml/min/1.73m\^2 for post-kidney transplant and stage iii or iv ckd patients: * bmi less than 40 kg/m\^2 * able to give informed consent * an estimated glomerular-filtration rate (gfr) of 20-60 ml/min/1.73m\^2 exclusion criteria: for healthy controls: -women pregnant or breastfeeding for stage iii or iv ckd patients: * women pregnant or breastfeeding * adults with a life expectancy of less than one year * a history of significant liver disease or congestive heart failure * hospitalization within the last three months * active infection on antibiotic therapy * uncontrolled hypertension (\>140/90) * immunosuppressive therapy within the last year for post-transplant stage iii or iv ckd patients: * women pregnant or breastfeeding * adults with a life expectancy of less than one year * a history of significant liver disease or congestive heart failure * hospitalization within the last three months * active infection on antibiotic therapy * uncontrolled hypertension (\>140/90)
the effect of atrial fibrillation hemodynamics on regulation of cerebral blood flow

Conditions: Atrial Fibrillation

Summary: the proposed research will investigate whether the irregular effects of atrial fibrillation on the body's circulation directly impacts the regulation of cerebral blood flow. to further delineate this finding, investigation of these potential effects will include differences in postural positioning. this data will be used to further understand the overall hemodynamic effects of atrial fibrillation on extra-cardiac organs of the body.

this is a prospective study evaluating 10 subjects referred for elective direct current cardioversion (dccv) of atrial fibrillation. subjects will be seen at parkland health and hospital system. after full consent is obtained and explanation of the research, each subject will undergo a series of entirely non-invasive tests including transcranial doppler ultrasound (tcd), manual cuff blood pressure (bp), beat to beat bp monitoring by a portapress monitor, and respiratory tidal co2. these measurements will be taken after laying the patient in a supine position for 10 minutes and subsequently after standing for 10 minutes. measurements will also be taken after full body squat -stand repetition at 20 second intervals (0.05 hz) x 5 minutes. patients who are unable to squat may rise from a seated position on a chair. this protocol has been easy to follow even for debilitated patients with alzheimers disease in dr. zhang and dr. levine's laboratory. the subject will then undergo elective dccv as planned for standard of care. the above measurements and with respective body positions will then be repeated 30 minutes later if the patient has been successfully converted to normal sinus rhythm by dccv. the experimental testing will take approximately 1 ½ to 2 hours to complete.

Eligibility criteria:
inclusion criteria: * subjects with atrial fibrillation scheduled for dccv * subjects must be at least 18 years of age * subjects must have the ability to understand and sign informed consent and be willing to comply with full testing and evaluation exclusion criteria: * subjects in sinus rhythm without assessment of any prior atrial fibrillation by this research team * subjects unable to understand and given informed consent

Keywords: direct current cardioversion, cerebral blood flow
tdcs to enhance cognitive training in schizophrenia

Conditions: Schizophrenia

Summary: the primary aim for the study is to determine whether transcranial direct current stimulation (tdcs) enhances training gains on cognitive training (ct) tasks. secondary aims are to determine whether tdcs combined with ct causes larger transferable improvements on non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are maintained over time (i.e., maintenance effects). specific hypotheses are: 1. ct combined with active tdcs will produce greater training gains on ct tasks compared to a similar control group receiving ct with sham tdcs. 2. ct combined with active tdcs will produce greater generalisation effects on non-trained cognitive tasks compared to ct with sham tdcs. 3. the cognitive improvements gained by patients from both interventions will be maintained over 1 month follow-up.


Eligibility criteria:
inclusion criteria: 1. subjects are 18 years of age or above. 2. subjects meet criteria for a dsm -iv schizophrenia or schizoaffective disorder but with a stable mental status as demonstrated by a stable positive and negative symptom score (panss) score over a period of 2 weeks. 3. subjects have had no medication changes in the 2 weeks prior to obtaining informed consent. 4. subjects are right-handed. 5. subjects able to give informed consent for the trial. exclusion criteria: 1. drug or alcohol abuse or dependence (preceding 3 months). 2. concurrent anticonvulsant or long acting benzodiazepine medication, as these medications may interfere with the effects of tdcs. 3. subject requires a rapid clinical response due to inanition, psychosis or high suicide risk. 4. clinically defined neurological disorder or insult, including history of seizures, cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥ 30 minutes. 5. subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed electrode sites. 6. female subject of child bearing age, sexually active and not using reliable contraception