Kornimate/medical-research-clean huggingface dataset:
associations between diabetes, arterial stiffness and fibulin-1 in patients undergoing heart- and vascular surgery?

Conditions: Coronary Artery Disease; Arteriosclerosis; Carotid Stenosis; Thrombosis; Aortic Aneurysm, Abdominal

Summary: diabetes mellitus (dm) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. dm is often related to increased arterial stiffness and hypertension. the investigators thesis is that dm and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. at the same time the investigators imagine that dm is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1. the investigators aim to describe the prevalence of type 2 dm and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. the results of this project will give us a measure for the quantity of unknown dm in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.


Eligibility criteria:
inclusion criteria: * \>18 years of age * undergoing heart- or vascular surgery exclusion criteria: * physical or mental disability not enabling participation in the study

Keywords: diabetes mellitus arteriosclerosis intima media thickness arterial stiffness pulsewave velocity fibulin-1
safety study of quadrivalent influenza virus vaccine in healthy people aged 3 years and older

Conditions: Quadrivalent Influenza Virus Vaccine

Summary: this study evaluates the safety of quadrivalent influenza virus vaccine in healthy people aged years 3 to 60.40 subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.adult group first receive one dose of quadrivalent influenza virus vaccine.then minors group also receive one dose of quadrivalent influenza virus vaccine after 7 days.


Eligibility criteria:
inclusion criteria: * healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent. * the subjects and his guardians can obey the demands of the scheme . * axillary temperature less than 37℃ exclusion criteria: * the people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs,ovalbumin etc. * the people who has serious side effects to vaccine, such as allergy,urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain. * the subject who has symptoms of acute infection within a week. * autoimmune diseases or immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months. * people has congenital malformations, developmental disorder or serious chronic diseases( such as down's syndrome, diabetes, sickle cell anemia or nerve system disease) * people has asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years. * diagnosed abnormal coagulation(lack of clotting factors,clotting disorders,platelet abnormality) or significant bruising or coagulopathy * people has history or family history of convulsions, seizures, encephalopathy and psychiatric. * alienia, functional asplenia, and alienia or splenectomy in any situation. * serious neurological disorders such as green barry syndrome. * people who has received blood products or immunoglobulin products in the past one months. * people who has received other study drug in the past one month. * people who received live attenuated vaccine, subunit vaccine or inactivated vaccine. * people who has received allergy treatment in in the past 14 days. * people who is on anti-tb treatment. * people whose axillary temperature is more than 37℃ before the vaccination. * people who is pregnant. * any factors unsuitable for clinical trail according to the researchers.

Keywords: vaccine safety
prevention of radiodermatitis in breast and head and neck cancer patients in cyprus

Conditions: Head and Neck Cancer; Breast Cancer

Summary: the treatment of cancer as a multidimensional disease has improved in recent years with the development of new chemotherapies, targeted biological therapies or radiation therapy protocols and have led to an overall improvement in the survival of oncology patients. these treatments often cause adverse effects on the skin, which can be accompanied by physical and mental suffering and have a significant impact on patients' quality of life. improving the quality of life of patients is today a therapeutic challenge. the objective of this clinical study is to assess the tolerability of an innovative skin cosmetic product that will be developed specifically for use during curative anticancer treatments, as well as to study the impact on quality of life of skin side effects caused by the treatments.


Eligibility criteria:
inclusion criteria: * over 18 years of age, * understand and be able to provide signed consent for the purpose of the research, * be diagnosed with breast or head and neck cancer, * undergo subfractionated radiotherapy of the breast in 15 sessions of a total dose of 40-42gy, with or without the administration of a booster dose (boost), * to know the greek or english language well * any wound should have healed after radiotherapy. the criteria will be evaluated by the medical staff of the hospital. exclusion criteria: * those who do not meet the aforementioned inclusion criteria as well as: * those who suffer from inflammatory cancer, * those who have untreated wounds and/or other serious dermatological problems * those with severe/extensive burns * those who suffer from serious mental disorders (dementia, drug addiction, etc.) that require intensive treatment or monitoring, * those who have a sensitivity/allergy to any of the product's ingredients. the criteria will be evaluated by the medical staff of the hospital.

Keywords: cancer breast cancer quality of life rct
a study to test long-term treatment with spesolimab in people with a skin condition disease called hidradenitis suppurativa (hs) who took part in a previous study with spesolimab

Conditions: Hidradenitis Suppurativa (HS)

Summary: this study is open to people with hidradenitis suppurativa (hs) who have completed another study with spesolimab (study 1368-0098 (nct05819398) or study 1368-0100). the purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with hs in the long-term. for about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. participants are in the study for about 2 years. during this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. at study visits, doctors check the severity of the participant's hs and collect information on any health problems of the participants.


Eligibility criteria:
inclusion criteria: 1. signed and dated written informed consent in accordance with ich harmonized guideline for good clinical practice (ich-gcp) and local legislation prior to admission to the trial. 2. participants must be within the defined residual effect period corresponding to 16 weeks since last spesolimab administration. 3. participants who have completed treatment in the parent hidradenitis suppurativa (hs) spesolimab trial (1368-0098 (nct05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial. 4. woman of childbearing potential (wocbp) must be ready and able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly. exclusion criteria: 1. women who are pregnant, nursing, or who plan to become pregnant while in the trial. 2. use of any drug considered by the investigator likely to interfere with the safe conduct of the trial since the last visit of the parent trials. 3. use of immunomodulatory biologics or investigational agents since the last visit of the parent trials. 4. participants who require / intend to use certain restricted medications such as immunomodulatory biologics or other investigational drugs/devices during the course of the trial. 5. relevant chronic or acute infections including human immunodeficiency virus (hiv) and viral hepatitis. the corresponding laboratory tests will be performed at visit 1. a participant can be re-screened if the participant was treated and is cured from the acute infection. further exclusion criteria apply.
clinical reasoning process of physiotherapists when observing hemiplegic gait

Conditions: Stroke

Summary: the goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait.

physiotherapists don't usually use any assessments to evaluate gait but observe it without an instrument. the questions in this study are: * what abnormalities can physiotherapists detect when observing a patient walking? * what do they consider the main problem that has a negative effect on the patient's walking? * what hypothesis do they generate? * how is the inter-rater reliability for the "main problem" and the hypothesis?

Eligibility criteria:
inclusion criteria: * chartered physiotherapists * physiotherapists in training * working with stroke patients exclusion criteria: - other languages than german

Keywords: clinical reasoning physiotherapists
comparison of flutter and pep mask on chest clearance, dyspnea in elderly asthmatic patients

Conditions: Asthma

Summary: this study will be a randomized controlled and will be conducted in allied hospital, faisalabad. the study will be completed within the duration of 10 months. convenience sampling study technique will be used to collect the data. the sample size of 30 patients will be taken in this study to find the effect of flutter and pep mask therapy on chest clearance and dyspnea. patients will be allocated randomly in two groups and 15 patients in each group. group a will get flutter device therapy. group b will get pep mask treatment. a regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. data will be analyzed on spss25.

this study will be a randomized controlled and will be conducted in allied hospital, faisalabad. the study will be completed within the duration of 10 months. convenience sampling study technique will be used to collect the data. the sample size of 30 patients will be taken in this study to find the effect of flutter and pep mask therapy on chest clearance and dyspnea. patients will be allocated randomly in two groups and 15 patients in each group. group a will get flutter device therapy. group b will get pep mask treatment. treatment will be given to all the participants 3 sessionsin a week, or 2 weeks and post treatment evaluation will be done after every week. a regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. data will be analyzed on spss25.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * both age above 40-60 years of age * both gender * no previous surgery exclusion criteria: * other pulmonary disease * neurological problems * rib fracture

Keywords: flutter pep mask chest clearance dyspnea
sequential administration of oral 6-thioguanine (6-tg) after methotrexate (mtx) in patients with relapsed hodgkin's disease (phase ii)

Conditions: Hodgkin's Disease

Summary: the objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant hodgkin's disease (hd) treated with sequential administration of oral 6-thioguanin (6-tg) after iv methotrexate (mtx).


Eligibility criteria:
inclusion criteria: * patients with histologic proof of hd who are in relapse and have failed \> or = to 2 prior chemotherapy regimens. * patients must have a life expectancy of at least 8 weeks. * all patients must have ecog performance level rating of \< or = to 2. * patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study. * patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of ct. * patients must have adequate liver function (bilirubin \ or = to 60 ml/min/1.73 m2). * patients should have a granulocyte count \> or = to 500/gl and a platelet count \> or = to 100,000/ul (unless due to disease involvement of the bone marrow). * male and female patients of child-bearing age should use effective methods of contraception, if sexually active. exclusion criteria: * patients with active infections or significant medical conditions other than their malignancy shall be excluded. * patients with hd who had prior mtx or 6-tg should be excluded.

Keywords: relapsed hodgkin's disease methotrexate 6-thioguanine 94-030
the effect of orofacial myofunctional therapy with autofeedback on obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the overall aim of this study is to estimate the effect of orofacial myofunctional therapy (omt) plus auto-monitoring compared to auto-monitoring alone. moreover, the investigators aim to identify anatomical and behavioural predictors of omt adherence

the overall aim will be addressed by reqruiting 100 participants to orofacial myofunctional therapy. 50 will be randomized to immediate treatment after the baseline consultation while 50 will get access to the treatment module after 3 monts of waiting. outcomes will be assessed by a researcher blinded for the randomization result.

Eligibility criteria:
inclusion criteria: * patients referred to ahus or the fertilitas clinic * a diagnosis of obstructive sleep apnea according to the current international classsification of sleep disorders (icsd) version 3 criteria {berry, 2020, the aasm manual for the scoring of sleep and associated events: rules', terminology and technical specifications', version 2.6.;, 2014, international classification of sleep disorders', 3rd ed.}, with a respiratory event index (rei) \<30. * not previously or currently treated with pap or mad * signed informed, written consent. * owning a mobile phone with software compatible for the study application age ≥18 year. * body mass index \<30 * ability to breathe through the nose * ability to read and willingness to follow the protocol as described in the written consent form * teeth 5-to 5 should be present or fixed by prosthesis or implants. * no botulinium toxin in facial muscles last three months exclusion criteria: * failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks. * medical or psychiatric conditions which may interfere with the study protocol in the opinion of the investigator. examples are acute psychosis, drug abuse and dementia. this will be noted in the study inclusion-exclusion document for each approached candidate for the study. the information will then be discussed in an exlusion committee consisting of dr. skirbekk, jagomägi, dammen and hrubos-strøm. * tongue-tie as described below. participants with mouth opening of \<50% with the tip of the tongue at the incisive papilla compared to total mouth opening will be excluded.
overnight closed loop study in u.s.

Conditions: Type 1 Diabetes

Summary: this is a multicenter feasibility study. up to 85 subjects will be enrolled in the study. the goal of the study is to demonstrate that the hybrid closed loop (hcl) system is safe to be used in an even larger study outside of hospital.

subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.there is no statistically powered study hypothesis testing. the investigational centers will be encouraged to include subjects of different ethnicities including hispanic, native american, and african-american. the study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. subjects are expected to participate for approximately 1- 2 months.

Eligibility criteria:
inclusion criteria: 1. subject is 2-75 years of age at time of screening 2. a clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis exclusion criteria that are based on demands of in-clinic study procedures : 3. pump therapy for greater than 6 months with use of real time cgm for any period of time (ie. one day) 3 months prior to screening 4. adequate venous access as assessed by investigator or appropriate staff 5. subject should have an established insulin carbohydrate and insulin sensitivity ratio. 6. subject reports at the time of screening that their average fasting glucose is 60 mg/dl - 200 mg/dl 7. subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (insulin pump memory for this information may be used)

Keywords: hcl type 1 diabetes sensor
drug intervention of spontaneous hyperventilation in patients with aneurysmal subarachnoid hemorrhage

Conditions: Hyperventilation; Aneurysmal Subarachnoid Hemorrhage; Cerebral Blood Flow

Summary: although spontaneous hyperventilation patients with aneurysmal subarachnoid hemorrhage closely associated with poor outcomes, the standard therapy remains unavailable. remifentanil has the pharmacological characterization of respiratory inhibition, mainly prolonging the expiratory time and decreasing the respiratory rate while preserving the respiratory drive. the investigators hypothesis that spontaneous hyperventilation could be corrected by titrating the dose of remifentanil and cerebral blood flow will augment during this process.

evidence has shown a high incidence of spontaneous hyperventilation in patients with aneurysmal subarachnoid hemorrhage (asah), which is associated with poor outcomes. it's well established that the hypocapnia caused by hyperventilation leads to cerebral vasoconstriction, reduces the cerebral blood flow, and decreases the cerebral blood volume and intracranial pressure consequently. however, persistent cerebral vascular constriction increases the risk of cerebral ischemia; therefore, maintaining a partial pressure of arterial carbon dioxide (paco2) in the range of 35-40mmhg is recommended to minimize the hazard hypocapnia. there's still no standard method to deal with spontaneous hyperventilation. based on the pharmacology and clinical experience, remifentanil seems to be an ideal choice since it could inhibit the respiratory rate in a dose-dependent fashion. as one of the most used short-acting opioids, remifentanil could prolong the expiratory time, meanwhile not influencing the inspiratory time and respiratory drive, consequently decreasing respiratory rate and maintaining the tidal volume. in this exploratory physiology study, the investigators will test the hypothesis that spontaneous hyperventilation could be suppressed by titrating the dose of remifentanil and could be realized as the target of paco2. the investigators will determine the optimal amount of remifentanil, which fulfills the criteria of efficacy and safety, and evaluate its effect on the cerebral blood flow velocity of both the middle cerebral artery and internal carotid artery.

Eligibility criteria:
inclusion criteria: * aneurysmal subarachnoid hemorrhage, after craniotomy or clipping * arterial blood gas satisfy with paco2\ 7.45 * presence of an endotracheal tube * assisted ventilation mode,cpap/psv * icp monitoring exclusion criteria: * age \<18 years * pregnancy * chronic obstructive pulmonary disease * allergy to opioids * clinically relevant hepatic or renal failure * hemodynamic instability * tcd windows cannot detect cerebral blood flow * refuse to participate the study

Keywords: spontaneous hyperventilation aneurysmal subarachnoid hemorrhage cerebral blood flow remifentanil partial pressure of carbon dioxide
evaluation of the presence of sens-401 in the perilymph

Conditions: Hearing Loss

Summary: the aim of this study is to detect the presence of sens-401 in the perilymph of participants undergoing cochlear implant surgery after 7 days of oral administration of sens-401.

the study is a phase iia, open-label, randomized and controlled study investigating repeated twice-daily administration of oral sens-401 in adult participants with moderately severe to profound hearing loss who have already agreed to undergo cochlear implant surgery justified by their hearing impairment. after written informed consent is obtained and screening procedures completed, 27 eligible participants will be randomized on day 1 to either arm a or arm b in ratio 2:1 (18 participants in arm a and 9 participants in arm b). arm a participants will commence dosing with twice-daily oral 43.5 mg sens-401 for 7 days prior to their scheduled cochlear implant surgery on day 8 and up to 42 days from day of surgery inclusive. arm b participants will not receive any treatment other than their scheduled cochlear implant surgery.

Eligibility criteria:
main inclusion criteria: potential participants must fulfil all of the following main inclusion criteria to be eligible for the study: 1. adults aged from 18 years and older; 2. meets the locally approved indication for cochlear implantation. the individual must have freely consented to the cochlear implant surgery before being offered to participate in the sens-401-203 study; 3. signed and dated written informed consent; main exclusion criteria: individuals will be excluded from the study if any of the following main exclusion criteria apply: 1. moderate to severe renal impairment defined by a creatinine clearance ≤ 60 ml/min 2. any condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or would preclude the participant from successful completion of the study 3. unable or unwilling to comply with the protocol requirements 4. known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
gore® viabahn® endoprosthesis post-marketing surveillance study (jps 16-03)

Conditions: Peripheral Arterial Disease

Summary: this study will confirm device efficacy and safety in the clinical setting after the launch of the gore® viabahn® endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.


Eligibility criteria:
inclusion criteria: * symptomatic peripheral arterial disease in superficial femoral artery lesions