Kornimate/medical-research-clean huggingface dataset:
a clinical study evaluating inhaled aviptadil on covid-19

Conditions: Covid19

Summary: this study is a multicenter, prospective, placebo-controlled, comparative, randomized, double-blind local phase ii clinical trial. duration of study is 18 months. in the study, patients will be randomized in a ratio of 1: 1 into two arms, standard medical therapy + placebo versus standard medical therapy + inhaled aviptadil arms. randomization will be carried out by the block randomization method. in the event that patients need intensive care in the study, the patients will be taken into intensive care unit and excluded from the study and their treatment will be continued in the intensive care unit as deemed appropriate by the physician and it is foreseen that inhaled aviptadil will be used for a period of minimum 7 and maximum 14 days. aviptadil will be discontinued in patients who do not heal after 14 days. this study includes 8 visits, consisting of a total of 7 physical visits and 1 phone follow-up visit. the study period will be 6 months for each patient. patient recruitment is planned to take 12 months. study centers will be asked to use investigational products for their patients who sign the informed consent form for 12 months. the study population will consist of patients 18 years of age and older with covid-19 pulmonary involvement and hospitalized patients.


Eligibility criteria:
inclusion criteria: 1.18 years and older women or men, under 70 years old 2.patients with positive sars-cov-2 real time pcr result and an appearance in line with covid-19 pneumonia on thorax ct 3. need for oxygen support or spo2 \<94 in room air 4. patients who can use a nebulizer (with assistance when necessary) 5.patients who are willing and capable (mentally and physically) who can sign a written informed consent form, to participate in all aspects of the study, to participate in the planned visits and to comply with the terms of the protocol. exclusion criteria: 1. intensive care admission 2. the need for mechanical ventilation 3. patients with previously known organ (kidney, heart and liver) failure \* to be determined as previously known heart failure (ef \<30), previously known liver failure (child-pugh c) and previously known renal failure (cr.clerance \<30). 4. covid-19 disease with no indication for hospitalization 5. participants in another clinical trial 6. pregnancy or lactation 7. solid organ or stem cell transplantation story 8. patients with collagen tissue disease 9. use of immunosuppressive therapy 10. procalcitonin ≥2 (baseline visit) 11. under 18 years old 12. those who had myocardial infarction in the last 3 months 13. those who do not have the capacity to understand the possible results, scope and nature of the study due to legal insufficiency and / or other reasons. 14. those who, in the opinion of the investigator, cannot continue the treatment protocol regularly or cannot cooperate 15. presence of malignancy 16. patients with neurological diseases

Keywords: aviptadil inhaled covid-19 pandemic
examining the effectiveness of transdiagnostic, internet-delivered cognitive behaviour therapy in new mothers experiencing anxiety and depression

Conditions: Depression, Postpartum; Anxiety

Summary: in the proposed study, the investigators will examine the efficacy of transdiagnostic, internet-delivered cognitive behaviour therapy (icbt) in the treatment of postpartum anxiety and depression. half of participants will receive the treatment immediately, and half of the participants will be assigned to a treatment-as-usual control condition. participants assigned to the control condition will be offered the treatment after a 12-week waiting period, although data from this portion will not be included in the current study. all participants will complete questionnaires prior to the start of the treatment, following treatment (or corresponding 8-week waiting period), at 1-months follow-up (or corresponding 12-week waiting period), and at 6-months follow-up (in those assigned to the treatment condition). further, those who receive the treatment will complete questionnaires on a weekly basis. the primary outcome measures include anxiety and depression. as part of the battery of questionnaires administered after the completion of the program, participants will be asked to rate the program content, the overall service, and their satisfaction with the program.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * female * have given birth and have a child under one year of age * score of 10 or above on epds or a score of 9 or above on the gad-7 * be a resident of saskatchewan * have access to a secure computer and the internet, and be comfortable using technology * be available to work through treatment each week * be willing to provide a medical contact as an emergency contact exclusion criteria: * younger than 18 years * not female * have not given birth to a child less than one year of age * are experiencing minimal to no symptoms of anxiety and/or depression * are not a resident of saskatchewan * have been hospitalized within the last year for mental health and/or suicide risk concerns; * have unmanaged problems with alcohol, drugs, psychosis or mania, or are at increased suicide risk (specific plans and intent reflected by the suicide behaviors questionnaire-revised) * started a new psychotropic medication within the past month * do not have access to a secure computer and the internet or is not comfortable using technology * are not available to work through treatment each week * are not willing to provide a medical contact as an emergency contact

Keywords: postpartum depression anxiety internet-delivered cognitive behaviour therapy randomized controlled trial therapist-assistance
treatment of survivors after botulism outbreak

Conditions: Respiratory Failure; Botulism

Summary: background. northern thailand's biggest botulism outbreak to date occurred on 14 march 2006 and affected 209 people. of these, 42 developed respiratory failure, and 25 of those who developed respiratory failure were referred to 9 high facility hospitals for treatment of severe respiratory failure and autonomic nervous system involvement. among these patients, we aimed to assess the relationship between the rate of ventilator dependence and the occurrence of treatment by day 4 versus day 6 after exposure to bamboo shoots (the source of the botulism outbreak), as well as the relationship between ventilator dependence and negative inspiratory pressure. methods. the investigators reviewed the circumstances and timing of symptoms following exposure. mobile teams treated patients with botulinum antitoxin on day 4 or day 6 after exposure in nan hospital (nan, thailand). eighteen patients (in 7 high facility hospitals) with severe respiratory failure received a low- and high-rate repetitive nerve stimulation test, and negative inspiratory pressure was measured.


Eligibility criteria:
inclusions: * ate the bamboo shoots in banluang district, on march,14 2006 * clinical of respiratory failure and need ventilator assistant * needed to referred to other hospital * the staffs of referred hospital willing to participate in the thai botulism study group exclusion criteria: * patients who did not eat bamboo shoots in banluang district on march14,2006. * no clinical of respiratory failure. * not referred to other hospital.

Keywords: botulism botulinum anti-toxin repetitive nerve stimulation respiratory failure
interest of calr allele burden in diagnosis and follow-up of patients with calr mutated myeloproliferative syndromes (calrsuivi)

Conditions: Myeloproliferative Neoplasm; Essential Thrombocythemia; Primary Myelofibrosis, Prefibrotic Stage; Primary Myelofibrosis, Fibrotic Stage

Summary: prospective study to evaluate the relevance of calr allele burden monitoring as a molecular marker of disease progression.

a first local study on 45 patients showed the prognostic impact of calr mutation quantification in follow-up, independently of the european leukemianet (eln) prognostic score validated in this group of patients. this study aims to evaluate a multicenter cohort of 260 patients, including all types of calr-mutated mpns and several follow-up samples, to model the temporal evolution of calr allele burden. blood of mpn patients will be collected, at the time of diagnosis and for 3 years (max 1 sample/year), for the quantification of the calr allele burden. during follow-up, a clinicobiological score to define the progression or not of the disease for each patient will be evaluated in essential thrombocythemia (et) and myelofibrosis (mf).

Eligibility criteria:
inclusion criteria: * adults (age ≥18 years), * affiliated to the national social security system, * with calr mutated myeloproliferative neoplasm diagnosed between 2006 - 2020, * for which at least one sample is available at the time of diagnosis or before cytoreductive treatment, * who signed the consent to participate in the study, * included, or consenting to be included, in the national clinical-biological database of france intergroupe syndrome myéloprolifératifs (fim). exclusion criteria: * patient with another active hematological disease or cancer at the time of diagnosis, * person subject to legal protection scheme or incapable of giving consent.

Keywords: calr myeloproliferative neoplasm essential thrombocythemia primary myelofibrosis thrombocytosis
study evaluating the olfactory recovery of anosmia post covid-19 by olfactory rehabilitation assisted by web-application

Conditions: Covid19

Summary: anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. however, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. however, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia in the context of the health crisis linked to the coronavirus, approximately 1 million french people will have persistent anosmia following an infection with covid-19. a web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching. covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.


Eligibility criteria:
inclusion criteria: * post-covid anosmia lasting more than 1 month * consent to the use of data via the application exclusion criteria: * other causes of anosmia than covid * contraindication to olfactory coaching (allergy to one of the aromatic oils) * minor

Keywords: web-application anosmia covid-19 coaching
the effect of probiotic streptococci and ph-rising components on the oral microbial flora

Conditions: Hyposalivation

Summary: the test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. the salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).

the aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative anaerobic streptococci (streptococcus oralis), ph-rising components and stevia on the oral microflora in hyposalivated subjects. material and methods: subjects with hyposalivation (unstimulated secretion rate of \< 0.1 ml/min and/or a stimulated secretion rate \< 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included. eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9 used placebo tablets and gel. the salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).

Eligibility criteria:
inclusion criteria: * no open wounds in the oral cavity * ≥ 10 own teeth * experienced dry mouth for at least 1 year * an unstimulated salivary secretion rate \< 0.1 ml/min * a stimulated secretion rate \< 0.7 ml/min and high numbers (≥ 10000 cfu/ml) of lactobacilli and/or mutans streptococci on the tongue and/or in dental plaque exclusion criteria: * removable prosthesis * reduced immune defence * serious heart diseases * implanted joints or heart valves * lactose intolerance (the probiotic streptococci are freeze-dried in skim milk)

Keywords: microflora probiotics hyposalivation lactobacilli mutans streptococci ph-rising components
gait adaptability training, using augmented reality, for individuals in the chronic phase after stroke

Conditions: Stroke

Summary: background: the majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. this impaired gait adaptability has a profound impact on activities of daily living and quality of life. treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. rehabilitation programs targeting gait adaptability have gained interest in clinical practice. besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. concerning gait adaptability, training programs are developed using the cmill, an instrumented treadmill with augmented reality. even though the efficacy of these interventions is limited to small, pilot trials, results are promising. based on these results we hypothesize that a gait training program using the cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke. objective: the primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. a second objective is to identify patient characteristics that predict a more favorable response to training. study design: randomized, waiting-list controlled trial to evaluate gait adaptability training study population: 84 stroke patients in the chronic phase after stroke


Eligibility criteria:
inclusion criteria: * \> 6 months after first unilateral supratentorial stroke (chronic phase) * able to walk at least 10 minutes independently exclusion criteria: * any other neurological or musculoskeletal disease affecting gait or balance (e.g. parkinson's disease, knee osteoarthritis) * contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period. * has received multiple training sessions on c-mill or grail in the past 12 months * severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
tomosynthesis of pathologies of the chest and skeletal structures in comparison to ct

Conditions: Lung Disease; Wrist Fracture

Summary: the investigators propose tomosynthesis as a imaging method in between of x-ray and ct. the expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing ct. specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants.

the investigators propose tomosynthesis as a imaging method in between of x-ray and ct. the expected value of this project is the definition of proven indications for tomosynthesis, which allow replacing ct. specific goals are the early detection of pulmonary consolidations / parenchymal changes as well as the monitoring of patients with ostesynthetic implants. this is a prospective, single-center, non-randomised, non-blinded trial with tomosyntheis of patients referred to the investigators institution to assess lung alterations and bone structure. all patients will undergo chest x-ray and tomosynthesis after informed consent. in addition they will undergo an ultralow-dose ct, wich is used as standart reference. the radiation dose of each method will be recorded. after completion of these three examinations, the participation in the study is completed.

Eligibility criteria:
inclusion criteria: * patients scheduled for evaluation of lung-changes * patients scheduled for evaluation of the wrist after fracture or surgery exclusion criteria: * general contraindications for x-ray * general contraindications for ct * pregnancy

Keywords: tomosynthesis osteosynthetic implant ct monitoring
accuracy of rte for evaluating hepatic fibrosis in chronic hepatitis: a prospective multicenter study

Conditions: Chronic Hepatitis

Summary: our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological s stages as the gold standard.


Eligibility criteria:
inclusion criteria: * 1. patient has a history of chronic hepatitis on clinical diagnosis; 2. patient undergoed liver biopsy during study time. exclusion criteria: * 1. patient cannot receive examination due to critical condition; 2. patient refuse the examination.

Keywords: real-time tissue elastography hepatic fibrosis
study to evaluate the clinical benefit response in cancer patients with advanced disease with amt2003 versus placebo

Conditions: Gastrointestinal Cancer; Prostate Cancer; Genital Neoplasms, Female

Summary: the purpose of the study is to evaluate the efficacy and the safety of amt2003 in cancer patients with advanced disease. the primary evaluation criterion is clinical benefit response.

the study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.) the clinical benefit response - cbr, is an end point that provides a clinical measure for symptom improvement in patients. the key evaluation parameters for cbr will be assessment of pain, the ability to perform daily activities and weight change.

Eligibility criteria:
inclusion criteria: * cancer confirmed by histology or cytology * at least one measurable lesion * advanced disease refractory to standard therapy or for which no standard therapy exists * life expectancy at least 3 months exclusion criteria: * known secondary neoplasia or central nervous system (cns) metastases, acute or chronic leukemia, lymphoma or multiple myeloma * body weight below 45 kg * female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods * concurrent severe or uncontrolled medical disease * acute or chronic liver disease * confirmed diagnosis of hiv * insulin dependent diabetes mellitus/abnormal glucose tolerance test (gtt)/latent diabetes mellitus type i or ii * chemotherapy or radiotherapy less than 4 weeks prior to entry * surgery less than 2 weeks prior to entry (or not recovered from effects of surgery) * participation in a clinical trial less than 30 days prior to entry into this study

Keywords: solid tumors clinical benefit quality of life esophageal cancer colon cancer pancreatic cancer gastric cancer liver cancer gall bladder cancer prostate cancer gynecological cancer lung cancer tumors of gi tract, prostate and gynaecological
en evaluation of navina mini, a new low-volume transanal irrigation device.

Conditions: Bowel Dysfunction

Summary: this is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (tai) as judged by the investigator. a total of 40 investigational subjects in need of low-volume tai will be recruited from 2-3 sites in sweden and will be treated with navina mini as per product intended purpose and per instruction of use during a period of four weeks. participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. the first visit, visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. visit 2 will be performed after two weeks of treatment through telephone contact. the final visit, visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.


Eligibility criteria:
inclusion criteria: * signed informed consent * anal incontinence or faecal outlet problems without any pathological obstruction in the ano-rectum. * symptom duration of \> 6 months * adult male and females \>18 years old * patient can communicate in written and oral swedish language exclusion criteria: * subjects treated with high volume tai i.e., volume \> 250 ml * pregnancy at the time of enrollment * participating in another clinical investigation interfering with this investigation * subjects with active, symptomatic inflammatory bowel disease, radiation proctitis and or active perianal fistula disease * rectal bleeding of uncertain origin or active hemorrhoidal bleeding * \< 6 months after anal or colorectal surgery * ongoing anti-coagulant therapy (eg. noacs, heparin, warfarin) * acute diverticulitis and diverticular abscess * ischemic colitis * colorectal cancer * any physical handicap that prevents usage of product * inability to use product or anyone to assist in its usage * person not suitable for the investigation according to the investigator judgement
comparison of nn5401 with biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and oceania. the aim of this clinical trial is to compare nn5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (od) or twice daily (bid), with or without oral antidiabetic drugs) (oads) (metformin, sulphonylurea (su), glinides, alpha-glucosidase inhibitor, dpp-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before visit 1 * hba1c 7.0-10.0 % (both inclusive) by central laboratory analysis * body mass index (bmi) below or equal to 40.0 kg/m\^2 exclusion criteria: * treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months * treatment with rosiglitazone or glucagon-like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1 * cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer