Kornimate/medical-research-clean huggingface dataset:
effect of intranasal corticosteroids on pulmonary symptoms in asthmatics with nasal congestion

Conditions: Asthma

Summary: in this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.

although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. this is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication. the "unified airways" concept considers the upper and lower airways as one unified airway. in recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms. conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. together will these mechanisms lead to a worsening of the asthmatic disease. the aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. the primary outcome variable is improvement in asthma symptomatology. the secondary outcome variables are improvement in nasal blockage.

Eligibility criteria:
inclusion criteria: * asthma (according to british thoracic society guideline) * \>18 years exclusion criteria: * pregnancy * systemic disease with nasal manifestations * cancer of the nose * currently receiving cancer therapy * previous nose surgery

Keywords: adrenal cortex hormones spirometry administration, intranasal nasal blockage nasal sprays
psilocybin therapy for depression in parkinson's disease

Conditions: Parkinson Disease; Depression

Summary: the purpose of this study is to understand whether people with parkinson's disease and depression have improvement in their symptoms after psilocybin therapy.

this is a randomized controlled trial of oral psilocybin therapy for depression in people with parkinson's disease (pd). the primary goal is to examine efficacy of psilocybin therapy in this patient population. we will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage parkinson's disease (hoehn and yahr stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. participants will also complete a series of psychotherapy sessions before and after each drug administration session. clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of pd, quality of life, and selected neural and blood-based biomarkers at multiple time points. follow-up will continue to 3 months after the second session. primary endpoints will evaluate efficacy, safety, and tolerability of study procedures.

Eligibility criteria:
inclusion criteria: * age 40 to 80 * comfortable speaking and writing in english * have neurologist-diagnosed idiopathic parkinson's disease (pd), hoehn and yahr stages 1 to 3 during an "on" phase (time when medication/dbs for parkinsonian motor feature, including bradykinesia and rigidity is in effect) * currently experiencing depressive symptoms * able to attend all in-person visits at ucsf as well as virtual visits * have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating exclusion criteria: * psychotic symptoms involving loss of insight * significant cognitive impairment * regular use of medications that may have problematic interactions with psilocybin * a health condition that makes this study unsafe or unfeasible, determined by study physicians

Keywords: parkinson disease depression psilocybin psilocybin therapy movement disorder
effects of resistance exercise during pregnancy

Conditions: Pregnancy

Summary: pregnant women at increased risk for back pain were studied during the second trimester and randomized to12-weeks of resistance exercise, education or waitlist. several outcomes were assessed including physical function, quality of life and mood.

a parallel group trial was completed at a single site. second trimester women (n=134) were randomly assigned (in blocks of 3) to 12-weeks of wait list, bi-monthly pregnancy education classes or twice weekly low-to-moderate intensity resistance training. resistance training involved one abdominal exercise with no external load and five exercises with an external load that gradually progressed (leg extension, leg press, arm lat pull, leg curl, and lumbar extension). several outcomes were assessed including physical function, quality of life and mood.

Eligibility criteria:
inclusion criteria: * pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy. exclusion criteria: * regular resistance exercise training (≥ twice per week during the past month) * an orthopedic or cardiovascular limitation * a psychiatric disorder * or had in the current or a prior pregnancy any of the following: * two or more miscarriages * premature labor * placental previa, * poor fetal growth, * low pre-pregnancy body weight (bmi \< 17.5) * a multiple birth pregnancy * pre-eclampsia * preterm rupture of membranes * uterine growth retardation * incompetent cervix/cerclage * recurrent vaginal bleeding * anemia or * diabetes.
non-surgical treatment of carpal tunnel syndrome by means of mechanical traction

Conditions: Carpal Tunnel Syndrome

Summary: the objective of this study is to evaluate the effectiveness of mechanical traction in patients with carpal tunnel syndrome compared to care as usual.

this randomized controlled trial will examine the effectiveness of mechanical traction compared to care as usual as a non-surgical treatment for carpal tunnel syndrome (cts). patients diagnosed with cts are recruited from the outpatient neurology clinic of viecuri medical center in venlo, the netherlands. they will be randomly assigned to the intervention or control group. patients in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. patients in the control group will receive care as usual, which can include splinting, a corticosteroid injection, carpal tunnel release surgery or an expectant strategy. outcomes will be assessed at baseline and at 3, 6, and 12 months after inclusion.

Eligibility criteria:
inclusion criteria: * diagnosed with cts using electrodiagnostic testing * being physically capable of visiting the outpatient clinic in venlo twice per week * being physically capable of sitting in upright position in a chair for 10-20 minutes, twice per week * not intending to move outside the area within 3 months after inclusion exclusion criteria: * not understanding dutch appropriately * other known (rare) cause of neuropathy * suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder

Keywords: carpal tunnel syndrome traction mechanical traction phystrac
phase 1b, open-label study of tune-401 to assess safety, pk and pd in adults with chronic hepatitis b

Conditions: Chronic Hep B; Chronic Hepatitis b; Chronic Hepatitis; HBV

Summary: this study will be conducted to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of tune-401 in adult participants with chronic hepatitis b.

this study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. the expansion phase will be open-label to further characterize the activity of tune-401 on pd parameters and obtain additional safety data.

Eligibility criteria:
inclusion criteria: * m/f age 18-75, inclusive * diagnosed with chronic hepatitis b * on nucleos(t)ide analogue * hbeag-negative or positive * hbsag \> 500 iu/ml * hbv dna \< 90 iu/ml exclusion criteria: * alt/ ast ≥ 1.5 × upper limit of normal (uln) and total bilirubin ≥ 1. 5 × uln * participants with any evidence or history of liver disease of non-hbv etiology * other protocol defined inclusion/exclusion criteria may apply

Keywords: tune-401 tune-401-001 chb
transparent cap-assisted endoscopic sclerotherapy

Conditions: Esophageal Varices

Summary: the aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyi(lauromacrogol injection) in management of esophageal varices.

endoscopic procedures now play a great role in management of esophagogastric varices. endoscopic variceal ligation(evl) was recommended as first line therapy for primary and secondary prophylaxis in patients with esophageal varices. previous studies have showed a superiority of evl over endoscopic injection of sclerotherapy(eis), mainly because of lower occurrence rate of complications. procedure related complications were related to total amount of lauromacrogol, number of treatment and expertise of the endoscopists. transparent cap has already been reported to assist in other endoscopic procedures, such as biopsy of barret esophagus or endoscopic submucosal dissection. accuracy and vision were improved with the help of transparent cap in the front of endoscopy. we have tried transparent cap-assisted sclerotherapy in some patients with in our hospital. now a randomized controlled trial was conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapy in management of esophageal varices.

Eligibility criteria:
inclusion criteria: * patients presented to our hospital with esophageal varices diagnosed by gastroscopy, with or without gastric varices. * the age of the patients range from 18 to 80 years old. exclusion criteria: * patients who have contraindications for lauromacrogol therapy or transparent cap. * patients who have no previous upper gastrointestinal bleeding history. * patients who have fecal disease that could greatly impact survival, such as uremia, advanced cancer or respiratory failure, et al.

Keywords: endoscopic sclerotherapy, esophageal varices, transparent cap
fractional flow reserve (ffr) versus instant wave-free ratio (ifr)

Conditions: Coronary Artery Disease; Plaque, Atherosclerotic

Summary: comparison of fractional flow reserve versus instant wave-free ratio for assessment of coronary artery stenosis severity in routine practice * to compare ffr to ifr in arbitrary consecutive patients referred for percutaneous coronary intervention (pci). * to investigate the influence of hyperemia on ifr. * to test reproducibility of ifr and ffr.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing ffr assessment for standard clinical indications. exclusion criteria: * prior cabg * extremely tortuous, calcified lesions * coronary artery occlusion * acute mi within 5 days

Keywords: atherosclerotic lesion assessment
implementation of optical diagnosis of diminutive colorectal polyps: discard3 study (incorporating ai-detect)

Conditions: Colonic Polyp

Summary: this is a prospective feasibility study. the aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. this study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to preservation and incorporation of valuable endoscopic innovations (pivi) criteria. a practical quality assurance program around optical diagnosis will be introduced. the use of a cad polyp-detection system will also be evaluated (ai-detect).


Eligibility criteria:
inclusion criteria: * patients aged 60-74 * with +ve faecal occult blood/faecal immunochemical test attending for screening colonoscopy within bcsp (bowel cancer screening programme) * with an established history of adenomas attending for surveillance colonoscopy within bcsp * patients aged 55 - referred for screening colonoscopy following positive bowel scope screening flexible sigmoidoscopy exclusion criteria: * patients with a risk profile (due to family history or other) whose follow-up will be outside standard bcsp * patients with inflammatory bowel disease * unable to consent * pregnancy
teduglutide for enterocutaneous fistula (ecf)

Conditions: Postoperative Fistula

Summary: the purpose of this study is to determine whether teduglutide is safe and feasible to be given for the treatment of enterocutaneous fistula (ecf). the hypothesis is that the drug will be well tolerated and will improve the volume of daily ecf output as well as improve the functional quality of life.


Eligibility criteria:
inclusion criteria: * age \>18 * enterocutaneous fistula (ecf) that could be secondary to volvulus, injury, prior trauma or surgery, or vascular ischemia exclusion criteria: * perianal fistula * clinical suspicion of inflammatory bowel disease * history of radiation enteritis or sprue (as defined by history) * active (\<1 year) alcohol or drug abuse * significant hepatic, or cardiac diseases as defined as: * hepatic: aspartate aminotransferase (ast) \> 2 times upper limit of normal (10-40 u/l) * cardiac: unstable angina or evidence of active myocardial ischemia (elevated troponin level drawn by clinical suspicion) * severe renal dysfunction: serum creatinine \> 2 times upper limit of normal (0.6-1.5 mg/dl) * received glutamine less than 4 weeks prior to screening * receiving growth factors (erythropoietin, granulocyte colony-stimulating factor, granulo-cyte-macrophage colony stimulating factor, and human growth hormone) * pregnancy or lactation (women of childbearing age will be excluded if they do not agree to either complete sexual abstinence during the study or if they refuse to use at least two forms of highly effective contraception such as oral contraception, injectable or implantable contraception, vaginal rings, or intrauterine devices (iud)) * active malignancy or suspicion for gastrointestinal malignancy on ct scan * not capable of understanding or not willing to adhere to the study visit schedule and drug administration requirements * family history of intestinal malignancy (gastric, small intestine, colon) * personal or family history of hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, first degree relative with colon cancer * positive hemoccult (per rectum) * abnormal baseline electrocardiogram (ecf) suggestive of congestive heart failure or underlying cardiac disease * taking oral benzodiazepines, barbiturates, or phenothiazines
study of predictors of clinical outcomes in patients with hr+ and her2-low/negative breast cancer

Conditions: Hormone-receptor-positive Breast Cancer; HER2-low Breast Cancer; HER2-negative Breast Cancer

Summary: there is a lack of data on clinical and patient factors that are associated with poor survival in patients with hr+ and her2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy. this retrospective, non-interventional study is designed to assess the predictors of clinical outcomes in this patient population. no study drug will be provided as part of this study protocol.

this retrospective, non-interventional study is designed to assess the following primary objectives: 1. to identify predictors of event-free survival (efs) in patients with hr+ and her2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy, and 2. to stratify patients according to event-free survival using different combinations of significant predictors and evaluate the patient characteristics and clinical outcomes such as efs, overall survival and pathological complete response across patient groups of different risk level.

Eligibility criteria:
inclusion criteria: * newly diagnosed hr+ and her2-low/negative breast cancer diagnosed between january 1, 2010 and december 31, 2022 (aged ≥18 years at the time of diagnosis) * stage i-iiib at the time of diagnosis * received neoadjuvant chemotherapy and/or endocrine therapy and/or io therapy * received curative intent surgery (mastectomy after neoadjuvant chemotherapy, endocrine, or io therapy) exclusion criteria: * patients who received her2-targeted therapies including * trastuzumab * pertuzumab * ado-trastuzumab emtansine * neratinib * tucatinib * lapatinib * fam-trastuzumab deruxtecan-nxki * margetuximab

Keywords: hormone-receptor-positive breast cancer her2-low breast cancer her2-negative breast cancer real-world data
proximal humeral comminuted fractures in the elderly - percele trial

Conditions: Humeral Fracture

Summary: fractures of the proximal humerus are common in elderly patients. the optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. the aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. the results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. main outcome measures are pain at rest and activity (nrss) and functional assessment of the shoulder with constant score. secondary outcome measures are simple shoulder test (sst), disabilities of the arm, shoulder and hand (dash), quality of life assessment (15d), subjective patient satisfaction and costs. the study also has a cohort follow-up of the patiens who decline randomisation. the recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in november 2019.


Eligibility criteria:
inclusion criteria: * age 65 years and older * acute trauma: 1. randomisation (op vs cons) within 7 days of injury. * 3- or 4-part fracture with \>5mm dislocation of the anatomic neck. * ao classification c1-2 for non-luxation fractures * ao classification c3 for luxation fractures exclusion criteria: * head splitting fracture * open fracture * additional fractures in the shoulder region * other injuries requiring surgical treatment * clinically significant injury of the brachial plexus or vasculature * pathological fracture associated with cancer * history of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc) * rheumatoid arthritis in the shoulder requiring active treatment * reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc) * unwillingness to accept some of the treatment options.

Keywords: shoulder fracture locking plate hemiarthroplasty conservative comminuted proximal humerus fracture
effect of probiotics in treatment of minimal hepatic encephalopathy (mhe) and health related quality of life

Conditions: Chronic Liver Disease; Hepatic Encephalopathy

Summary: this study is a randomized, open, parallel group, active comparator, single center trial. objectives of the study are hereby given below: * to study the health related quality of life (hrqol) in patients with chronic liver disease. * to assess the prevalence of minimal hepatic encephalopathy (mhe) in patients with chronic liver disease and assessment of hrqol in patients with mhe. * to compare the effect of probiotics and lactulose in the treatment of mhe * to assess the effect of probiotics and lactulose on the hrqol in patients with mhe.

the study design would comprise of two parts 1. part i: cross sectional study: this part would comprise of the assessment of hrqol in patients with cld 1. all the consecutive patients diagnosed as cld would be enrolled in the study. all these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at aiims. 2. alcohol would be considered to be the cause of cld, if the patient regularly consumed ≥80g/d of alcohol for five years 3. the staging of cirrhosis would be done according to the child pugh classification: a, b and c 4. the causes of cld would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes 2. part ii: prospective randomized controlled trial: in this part the outcome of lactulose and probiotic therapy in the treatment of mhe and its effect on the hrqol will be compared. 1. all the consecutive patients with cld without overt encephalopathy would be screened for mhe. 2. all these patients would be enrolled from the liver clinics and the gastroenterology ward, aiims. 3. the diagnosis of mhe would be based on abnormal psychometric tests (nct-a and nct-b or fct-a and fct-b) and /or abnormal p300 auditory event related potentials.

Eligibility criteria:
inclusion criteria: * all the patients with chronic liver disease or minimal hepatic encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively. exclusion criteria: * patients with overt hepatic encephalopathy * active medical co-morbidities like chd, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc * malignancy * history of taking lactulose or probiotics or antibiotics, in the past 6 weeks * presence of other neurological or psychiatric disorder * patients who underwent shunt surgery for portal hypertension * history of taking medicines likely to interfere with psychometric performance * history of gi hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks * presence of mature cataracts and diabetic retinopathy * refused to participate in the study
dendritic cell vaccine study (dc/pc3) for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the safety and activity of dc/pc3, a dendritic cell vaccine used as immunotherapy for prostate cancer. the vaccine is made with each participants' own immune cells obtained through blood donation. dendritic cells are known to activate other immune cells such as t cells, that are able to mount an attack against cancer cells. the dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.

see brief summary.

Eligibility criteria:
inclusion criteria: prostate cancer rising prostate specific antigen (psa, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen a2.1 (hla-a2.1) - exclusion criteria: central nervous system metastasis history of autoimmune disease

Keywords: prostate cancer