Kornimate/medical-research-clean huggingface dataset:
lrrk2 and other novel exosome proteins in parkinson's disease

Conditions: Parkinson's Disease

Summary: this proposal seeks to 1) determine whether there are biomarkers associated with parkinson's disease (pd) susceptibility and/or progression in exosome-proteomes derived from pd patients versus controls, and 2) to determine if lrrk2 expression and/or phosphorylation are significantly lowered in the exosomes of individuals treated with the potent lrrk2 kinase inhibitor sunitinib (a multi-kinase inhibitor compound), to establish an assay for on-target effects for future lrrk2 inhibitor clinical trials.


Eligibility criteria:
inclusion criteria: parkinson's disease inclusion criteria: inclusion criteria will be based on uk brain bank criteria for the clinical diagnosis of pd. these require 1) the presence of bradykinesia and either rest tremor or rigidity; 2) asymmetric onset; 3) progressive motor symptoms 4) age at onset 21-99 years. control inclusion criteria: ages of between 21-99 years, a lack of pd in first-degree blood relatives, and a lack of positive responses on more than 3 items on the pd screening questionnaire. exclusion criteria: for all subjects: include atypical features indicative of a parkinson-plus disorder (progressive supranuclear palsy (psp), multiple system atrophy (msa), corticobasal degeneration (cbd)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, history of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\< 5 years), dementia, known severe anemia (hematocrit \<30), history of kidney disease and/or current or past glomerular filtration rate (gfr) \<60 possibly indicative of kidney disease, or a serious comorbidity that may interfere with participation in the study.
endoscopic treatment of zenker's diverticulum (zenktun)

Conditions: Zenker Diverticulum

Summary: prospective comparative observational study in numerous reference centers in france, comparing tunnelization (z-poem) versus non-tunnelization techniques according to the usual practices. this is a prospective, comparative, observational, multicenter study with the primary objective of comparing the symptomatic recurrence rate one year after endoscopic tunnelization therapy (z-poem) versus non-tunnelization techniques in patients with symptomatic zenker's diverticulum.


Eligibility criteria:
inclusion criteria: * patients with symptomatic zenker's diverticulum (augsburg score ≥5 ) * diagnostic evaluation including esophagogastroduodenoscopy (egd) and a barium swallow (togd) with measurement of the diverticulum's height. * patient aged 18 years or older * patient with asa 1, asa 2, asa 3 status * no participation in another concurrent clinical study exclusion criteria: * patient under 18 years old * patient with asa 4 or asa 5 status * pregnant woman * patient with coagulation disorders preventing the performance a polypectomy: pt \< 50%, platelets \< 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use. * patient who has already undergone initial endoscopic or surgical treatment for zenker's diverticulum

Keywords: zenker's diverticulum z-poem diverticuloscope knife septotomy clutch cutter
the use of samsung health and ecg m-trace base ii applications in the secondary prevention after stroke

Conditions: Mobile Applications; Secondary Prevention; Stroke

Summary: the aim of the present study was to quantitatively assess the risk factors that may affect the re-occurrence of a cvd event and the use of a commercially available mobile application samsung health for the assessment of parameters of exercise tolerance and the ecg m-trace base ii application for the assessment of cardiological parameters.

in the post-stroke group and in the control group, smwt (six minute walk test) and sct( stair climb test) were preceded by a 10-minute rest in sitting position. the time of test performance, the walked distance and steps made as well as the mean and maximum gait velocity and the calories burned were assessed using the above-mentioned samsung health application . ecg results were assessed with the use of ecg m-trace base ii application described above. in addition, cardiological parameters such as: systolic blood pressure (sbp) and diastolic blood pressure (dbp), heart rate (hr) and arterial blood saturation were assessed. the measurements were performed at rest and directly after scmt and sct. additionally, after the tests, the level of dyspnoea and fatigue was assessed according to the modified borg scale (score 0-10).

Eligibility criteria:
inclusion criteria to the post-stroke group were as follows : 1. occurrence of hemiparesis after the first episode of ischaemic stroke 2. stroke confirmed in the diagnostic imaging records 3. score \>3 on lovett's scale of muscle strength in the paretic limbs 4. score above 15 in barthel's scale of performance in activities of daily living 5. score below 12 in the national institutes of health stroke scale (nihss) 6. available complete medical records concerning the assessed risk factors of recurrent cvd event 7. lack of concomitant pulmonary diseases including chronic obstructive pulmonary disease and bronchial asthma exclusion criteria from the post-stroke group were as follows: 1. hemiparesis or tetraparesis following many episodes of stroke, 2. lack of diagnostic imaging scans confirming the occurrence of stroke 3. hospital stay at the department of neurological rehabilitation for more than 14 days from the occurrence of stroke 4. incomplete medical records concerning the assessed risk factors of recurrent cvd event 5. score \>3 on lovett's scale of muscle strength in the paretic limbs 6. score below 14 in barthel's scale of performance in activities of daily living 7. score above 13 in the nihss scale 8. occurrence of factors limiting walking ability, such as diagnosed pulmonary diseases, unstable angina, severe valvular heart diseases, cardiomyopathy, musculoskeletal or autoimmune diseases.
effect of adc4022 co-administered with budesonide on pulmonary inflammation in subjects with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (adc4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe chronic obstructive pulmonary disease (copd) when co-administered with budesonide and compared to placebo.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of copd that has been symptomatic for at least 2 years * the subject has moderate to severe copd, as defined by the american thoracic society and the european respiratory society * the subject can produce an adequate sputum specimen after induction * the subject has a history of ≥ 10-pack years of cigarette smoking * the subject has either a ≤15% increase or ≤200 ml increase in fev1 from pre-dose following a fixed dose of bronchodilator therapy * the subject is able to provide written, informed consent to participate exclusion criteria: * the subject has experienced a respiratory tract infection and/or an exacerbation of copd within 30 days * the subject uses systemic corticosteroids (oral or parenteral) * the subject has received long term oxygen therapy within 30 days * the subject has a previous history or diagnosis of asthma * the subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than copd * the subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases * the subject has had radiation or chemotherapy within the previous 12 months * the subject has a history of anaphylaxis associated with medicinal products * the subject is pregnant, intends to become pregnant, or is breast feeding * the subject's alcohol intake is excessive. * the subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study. other inclusion/exclusion criteria may also apply

Keywords: copd
optimal site of administration for continuous wound infusion after cesarean section

Conditions: Cesarean Section

Summary: the purpose of this randomized double-blind study is to evaluate in which anatomical layer (af versus bf) continuous wound infusion of local anesthetics combined with nsaids through a multiorifice catheter has the best effectiveness during the first 48 hours on postoperative pain intensity after elective cesarean delivery.


Eligibility criteria:
inclusion criteria: * elective cesarean section under spinal anesthesia over37 weeks' gestation exclusion criteria: * allergy to nsaids * asa iii or higher * refusal to participate
gemcitabine/cisplatin/s-1(gcs) combination therapy for patients with advanced biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: the objective of this study is to evaluate the safety of gcs therapy for phase i and efficacy of gcs therapy for phase ii.

biliary tract cancer is one of the most lethal malignancies worldwide, with surgery representing the only potentially curative treatment for this disease. however, many patients are diagnosed too late for curative resection, and even if surgery can be performed, the likelihood of relapse is very high. over the past decade, gemcitabine has been widely used to treat unresectable or recurrent biliary tract cancer patients. in the abc-02 study, the first prospective multicenter phase iii study in this field, gemcitabine/cisplatin combination chemotherapy was compared with gemcitabine monotherapy and found that the combination regimen significantly prolonged mst (from 8.1 to 11.7 months; p \< 0.001). gemcitabine/cisplatin combination therapy is now considered to be the standard regimen for advanced biliary tract cancer. s-1 is an oral fluoropyrimidine prodrug that has confirmed efficacy against various solid tumors, both alone and in combination with other cytotoxic drugs. s-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabine/s-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer. in this study, we aimed to determine the safety and efficacy of adding s-1 to gemcitabine/cisplatin combination regimen for advanced biliary tract cancer.

Eligibility criteria:
inclusion criteria: * 1. patients with cytologically or histologically proved biliary tract cancer 2. age \>=20 years 3. ps 0-2 4. no prior history of chemotherapy or radiotherapy. patients who have undergone adjuvant chemotherapy are eligible if at least 6 months have passed since the last administration. 5. adequate bone marrow function (neutrophil count \>=1,500/mm3, and platelet count \>=100,000/mm3), liver function (total bilirubin \>=3 mg/dl and ast/alt \>=150 iu/l), and renal function (creatinine clearance \>=60 ml/min) 6.no other serious comorbid disease 7.adequate oral intake 8.provided written informed consent exclusion criteria: * 1. patients with interstitial pneumonia or pulmonary fibrosis 2. patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. patients with severe active infection 4. patients who are pregnant or lactating, or have an intention to get pregnant 5. patients with a history of severe drug allergy 6. patients with other serious comorbid disease 7. patients with mental disease 8. patients who are judged inappropriate for the entry into the study by the principle doctor 9. patients with watery diarrhea
single centre blinded randomized controlled trial evaluating the effectiveness of two pelvic support garments

Conditions: Pelvic Pain; Symphysis Pubis Dysfunction

Summary: this blinded randomized comparative trial aims to determine the effectiveness of a customized dynamic elastomeric fabric orthoses (defo) compared to a standard pelvic belt in: a) reducing pregnancy-related pelvic girdle pain (pgp), b) optimizing activity levels in pregnant women with pgp, c) improving quality of life for pregnant women with pgp d) cost effectiveness.

pelvic girdle pain (pgp) occurs in an estimated 70% of pregnant women, of whom 25% have severe pain and 8% significant disability. current methods of management, such as the use of rigid pelvic belts, are limited in their effectiveness. the dynamic elastomeric fabric orthoses (defo) has recently proven beneficial in managing pgp in athletes. there is a need to explore the potential use of defo for managing pgp during pregnancy. the primary aim of the study is to compare the effectiveness of a defo to a rigid 'off the shelf' pelvic support belt in terms of its effectiveness in reducing pgp during pregnancy. the secondary aims of the study are to compare the effectiveness of the defo to the rigid 'off the shelf' pelvic support belt in (a) optimizing activity levels in pregnant women with pgp, (b)improving quality of life for pregnant women with pgp. the relative cost effectiveness of these two interventions will also be compared.

Eligibility criteria:
inclusion criteria: women 20-36 weeks pregnant, who: * report intermittent pgp (commenced or aggravated during pregnancy) which causes walking and/or stair climbing to be bothersome and * are positive on at least 3 out of 7 pain provocation tests exclusion criteria: * recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory, infective, traumatic, neoplastic, degenerative or metabolic, i.e. trauma, unexplained weight loss, history of cancer, steroid use, drug abuse, hiv infection, immunosuppressed state, neurological symptoms/signs such as: bowel, bladder, sensory, motor, reflex involvement (cauda equina, lumbar disk lesion, spinal stenosis,) * fever * systemically unwell * obstetric complications * pain that does not improve with rest/severe disabling pain * history of chronic back or pelvic pain requiring surgery * focal inflammatory signs/tenderness of spine (spondylolisthesis) * known skin allergy to lycra * \>36 weeks pregnant (production of customized defo will take approximately 1 week)

Keywords: pelvic girdle pain symphysis pubis dysfunction sacroiliac joint sacroiliitis physiotherapy physical therapy orthotic devices
multicenter italian validation of ehp-30

Conditions: Endometriosis; Quality of Life

Summary: the experience of the chronic illness negatively engraves on the quality of life of patients. endometriosis is a disease that affects millions of women of childbearing age; it has repercussions on psychological health, as shown by numerous recent studies. the aim of the present study is to validate the italian version of eph 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.


Eligibility criteria:
inclusion criteria: * previous surgical and histological diagnosis of endometriosis exclusion criteria: * severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological) * psychiatric diseases * refusal or inability to sign the informed consent
a transdiagnostic course for common mental health problems in primary care

Conditions: Depression; Anxiety

Summary: this study investigates the feasibility of a transdiagnostic course that is intended to work for a large variety of patient groups with clinically significant depression or anxiety in primary care. this is a prospective single-group study where 68 adults with clinically significant symptoms of depression or general anxiety, and up to 25 adults with subclinical symptoms, attend up to 6 weekly structured large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. if necessary, due to the covid-19 pandemic, the course will be held online.

background: depression and the common anxiety disorders are highly prevalent and associated with disability and reduced quality of life. there is reason to believe that the majority of these patients are found in primary care. official swedish guidelines dictate that primary care clinics are responsible for treating mild to moderate cases, but access to treatment is limited. transdiagnostic psychological interventions have been found to be efficacious for anxiety and mood disorders, and require a relatively rudimentary pre-treatment assessment. a large-group transdiagnostic course based on cognitive-behavioral principles may constitute an effective use of limited resources to improve access to treatment, and offer a sufficiently effective intervention, for most primary care patients with mild to moderate mental health problems. aim: to investigate the feasibility and preliminary efficacy of a large-group transdiagnostic intervention for depression and clinically significant anxiety in swedish primary care. design: this is a prospective single-group feasibility study where 68 adults with clinically significant symptoms of depression or anxiety, and up to 25 adults with subclinical symptoms, are recruited from liljeholmen primary care clinic, stockholm, and offered 6 weekly structured transdiagnostic large-group course sessions which focus on evidence-based strategies to reduce psychiatric symptoms and increase wellbeing. if necessary, due to the covid-19 pandemic, the course will be held online. the primary outcome is patient satisfaction. secondary outcomes include within-group effects on psychiatric symptoms (response rates), adherence rates, need for additional treatment, and adverse events.

Eligibility criteria:
inclusion criteria: * at least 8 points on the gad-7 or 10 points on the phq-9 (n=68; up to 25 subclinical participants may also take part in the study) * at least 18 years old exclusion criteria: * at least one severe mental health problem such as suicidal ideation, a bipolar disorder, or psychosis * non-stable antidepressant medication (dosage changed during the past 6 weeks) * planned absence for 2 weeks or more of the intended treatment period

Keywords: transdiagnostic primary care feasibility
lunch time insulin injection by school nurse for poorly controlled diabetes

Conditions: Type 1 Diabetes

Summary: we hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled t1dm.

the diabetes control and complications trial (dcct), for type 1diabetes (t1dm), showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes. however, adolescents with t1dm continue to be a high-risk population due to the difficulties in coping with the physical, emotional, and social demands associated with managing diabetes themselves. we propose to use the school nurse to help with lunchtime blood sugar monitoring (bsm) and with a lunchtime insulin injection. we want to see if this will improve blood sugar control, improve school grades, and decrease absences from school in adolescents with poorly controlled diabetes. subjects will receive 12 weeks of this treatment to see if they will have improved glucose control. we hope to improve blood sugar control, school grades and decrease absences from school in teens with poorly controlled diabetes.

Eligibility criteria:
inclusion criteria: * child with t1dm for at least 1 year * age 10-19 years * have a hgb a1c greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months. * school must have a school nurse exclusion criteria: * child who has type 2 diabetes * subject receiving home schooling

Keywords: type 1 diabetes poorly controlled glucose adolescents
clinical outcomes of patients with covid19

Conditions: Coronavirus Disease 2019

Summary: as of february 17th, 2020, china has 70635 confirmed cases of coronavirus disease 2019 (covid-19), including 1772 deaths. human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. the number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.


Eligibility criteria:
inclusion criteria: * hospitalized patients with covid19 exclusion criteria: * suspected patients with covid19, not confirmed by the laboratory * patients who are refused to receive medical treatments
study to assess the safety of nivolumab in the treatment of metastatic melanoma, lung cancer, renal cancer, squamous cell carcinoma of the head and neck, and chronic hodgkin lymphoma in adults in mexico

Conditions: Multiple Indications Cancer

Summary: this is a post-marketing study of patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (sqnsclc) , metastatic non-sqnsclc, metastatic renal cell carcimona (rcc), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (scchn), or third-line therapy for classical hodgkin lymphoma (chl) in mexico.


Eligibility criteria:
inclusion criteria: 1. male and female adult patients \> 18 years of age who have a confirmed diagnosis of advanced or metastatic melanoma and is indicated for the treatment of advanced (unresectable or metastatic) melanoma; metastatic nsclc; metastatic rcc; recurrent or metastatic scchn; or chl in mexico 2. male and female adult patients \> 18 years of age who completed the following lines of therapy: first-line platinum treatment for metastatic sqnsclc or non-sqnsclc; 1 first-line treatment for metastatic rcc; first-line platinum therapy for scchn; or bretuximab vedontin for the treatment of chl 3. patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation 4. patients have received at least 1 dose of nivolumab exclusion criteria: 1. the exclusion criteria are at the discretion of the physician. the physician should use his or her clinical judgement and international recommendations when determining eligibility. the patient will be excluded if he or she does not want to start or continue treatment.