Kornimate/medical-research-clean huggingface dataset:
imiquimod and influenza vaccine for immunocompromised patients

Conditions: Influenza Vaccine

Summary: in this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consisting in the topical administration of imiquimod at the injection site before vaccination vs. a standard intramuscular vaccine injection in sot recipients and hiv-infected individuals. the investigators planned to enroll 70 outpatients patients (50% solid-organ transplant recipients and 50% hiv-infected patients) regularly followed at the transplantation center and the infectious disease outpatients' clinics of the lausanne university hospital. study participants will be randomized in a 1:1:1 ratio to receive the standard intramuscular vaccine (control group) or a topical application of an imiquimod containing cream followed by intramuscular (imiquimod-im) or intradermal (imiquimod-id) vaccine injection. after vaccination participants will be followed for a period of 180 days. blood samples will be drawn at baseline and at day 21 and 180 for assessment of immunogenicity. safety outcomes will be assessed immediately after vaccine administration, and at day 7 (phone call), 21 and 180.


Eligibility criteria:
inclusion criteria: * provision of written, informed consent * age \> 18 years * hiv infection or at least 3 months after kidney transplantation * stable outpatients * able and willing to comply with the study protocol exclusion criteria: * documented egg and/or imiquimod allergy * previous life-threatening reaction to seasonal influenza vaccine (i.e. guillain-barré syndrome) * previous severe reaction to imiquimod cream * pregnancy or breast-feeding * patients with autoimmune diseases * for hiv-infected patients: * current active opportunistic infection * for kidney transplant recipients: * ongoing therapy for rejection (including steroid pulse or prednisone \> 2 mg/kg/day over more than 14 days) * ongoing therapy with ivig and eculizumab or current and past (\<6months) therapy with rituximab

Keywords: influenza vaccine transplantation imiquimod hiv infection immunogenicity
dysphagia symptom severity and quality of life

Conditions: Neurogenic Dysphagia

Summary: the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.

the dysphagia related quality of life and perceived dysphagia symptom severity by patients will be used as a complementary information on oropharyngeal dysphagia. thus, the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.

Eligibility criteria:
inclusion criteria: * willing to participate in the study * being over the age of 20 * normal cognitive function * suffering from dysphagia at least one month exclusion criteria: * being under the age of 20 and above 65 years. * abnormal cognitive function * clinically unstable neurological disease
pharmacokinetic and efficacy study of fluocinolone acetonide inserts in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema


Eligibility criteria:
inclusion criteria: * age \>= 18 years with diabetic macular edema * diagnosis of diabetes mellitus types 1 or 2 * best corrected visual acuity of ≥ 19 letters * retinal thickness \> 250 microns by oct * investigator is comfortable deferring macular laser treatment for 6 weeks exclusion criteria: * glaucoma, ocular hypertension, iop \>21 mmhg or concurrent therapy at screening with iop lowering agents * retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy * prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months * prior intravitreal or subtenon anti-vegf therapy within the last 2 months * any ocular surgery within the last 3 months * retinal laser treatment within the last 3 months * history of uncontrolled iop elevation with steroid use that did not respond to topical therapy * any lens opacity which impairs visualization of the posterior pole
study investigating the pharmacokinetic properties of the drug lu af35700 in subjects with liver impairment and in healthy subjects

Conditions: Hepatic Impairment

Summary: the purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of lu af35700


Eligibility criteria:
inclusion criteria: * subjects with hepatic impairment disease stage child-pugh's criteria a (mild) or child-pugh's criteria b (moderate) and healthy subjects with normal hepatic function * subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive) exclusion criteria: * subjects previously been dosed with lu af35700 other protocol defined inclusion and exclusion criteria may apply
telemedicine makes the patient stay in hospital at home

Conditions: Spinal Cord Injury; Pressure Injury

Summary: the goal of the project is to study whether multidisciplinary follow- up performed via telemedicine to the patient in his or her own home, will improve the healthcare services offered to a particular group of patients. the hypotheses are that this could increase the treatment options, increase knowledge translation, give significant socioeconomic benefits, and allow greater accessibility to specialized healthcare services, as well as increase the involvement of patients and those working in primary healthcare.

the goals of rehabilitation are to improve functional level, decrease secondary morbidity and enhance health-related quality of life. the costs associated with pressure injury are considerable. in addition to direct treatment- related costs, pressure injury also impact the hospital performance metrics. on top of the financial implications, pressure injury have a significant impact on patient morbidity and -mortality, as well as on health related quality of life. the researchers believe there is a large potential for improvement in treatment of pressure injuries. an multidisciplinary approach, including home-based rehabilitation programs, might help prevent pressure injuries and their complications, and thus reduce associated costs. the investigators conducted a pilot in 2012, in which patients with spinal cord injury and pressure injury were monitored through multidisciplinary outpatient home care, using telemedicine. the project was beneficial for the consumers/ patients, especially in terms of consumer- participation and -contribution, improved quality of life, and a better cooperation between primary and specialized healthcare services. retrospective economic analysis indicated that telemedicine provides great savings for public healthcare services, and that using telemedicine with other patient groups with similar problems, could be beneficial. a positive outcome of the current study can be made available to most people with pressure injury. knowledge about pressure injury will contribute in both planning and establishment of good treatment lines for the patients, as well as contribute to environmental savings, and more proper use of the health resources. this may reduce the consumption of hospital services, because a larger proportion of services are provided by the municipality. an important scientific significance of this research will thus be to improve, simplify and streamline health care and health- related services.

Eligibility criteria:
inclusion criteria: * traumatic or non- traumatic sci and ongoing pressure injury. * consent to participate. exclusion criteria: * patients who are unable to give their consent due to cognitive problems. * patients who do not have a permanent/ known address.

Keywords: spinal cord injury pressure injury health related quality of life telemedicine service innovation rehabilitation interdisciplinary collaboration user-participation activity and participation health economics
radiomics signature of hepatic venous pressure gradient (rhvpg) with ct angiography (chess1701)

Conditions: Hypertension, Portal

Summary: this is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers in china designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rhvpg) (investigational technology) by ct angiography (cta) for noninvasive assessment of the clinically significant portal hypertension (csph) in patients with cirrhosis. direct hepatic venous pressure gradient (hvpg) measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of csph, which is defined as hvpg≥10 mmhg.

this is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers (302 hospital of pla; beijing shijitan hospital; the third xiangya hospital of central south university; beijing youan hospital; xingtai people's hospital) in china designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rhvpg) (investigational technology) by ct angiography (cta) for noninvasive assessment of the clinically significant portal hypertension (csph) in patients with cirrhosis. direct hepatic venous pressure gradient (hvpg) measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of csph, which is defined as hvpg≥10 mmhg.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients providing written informed consent * patients with cirrhosis and scheduled to undergo clinically-indicated invasive hvpg measurement by means of catheterization of a hepatic vein with a balloon catheter * has undergone \> 64 multi-detector row ct within 14 days prior to hepatic vein catheterization * no hepatic-portal vein interventional therapy between the ct and hepatic vein catheterization exclusion criteria: * prior transjugular intrahepatic portosystem stent-shunt surgery * prior devascularization operation * has received a liver transplant * patients with known anaphylactic allergy to iodinated contrast * pregnancy or unknown pregnancy status * patient requires an emergent procedure * any active, serious, life-threatening disease * inability to adhere to study procedures

Keywords: clinically significant portal hypertension hepatic venous pressure gradient radiomics
a study of the efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this is a phase ii, multicenter, randomized, parallel-group, partially blinded, placebo and avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain mri lesions, and safety of 2 dose regimens of ocrelizumab in participants with relapsing remitting multiple sclerosis (rrms).


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and to be compliant with the schedule of protocol assessments * relapsing-remitting multiple sclerosis (ms) * ages 18-55 years inclusive * for sexually active female and male participants of reproductive potential, use of reliable means of contraception exclusion criteria: * secondary or primary progressive multiple sclerosis at screening * incompatibility with mri * contra-indications to or intolerance of oral or iv corticosteroids * known presence of other neurologic disorders * pregnancy or lactation * lack of peripheral venous access * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies * significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal * congestive heart failure * known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening * history or known presence of recurrent or chronic infection * history of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved) * history of alcohol or drug abuse within 24 weeks prior to randomization * history of or currently active primary or secondary immunodeficiency * history of coagulation disorders * treatment with any investigational agent within 4 weeks of screening * receipt of a live vaccine within 6 weeks prior to randomization * incompatibility with avonex use * previous treatment with rituximab * previous treatment with lymphocyte-depleting therapies except mitoxantrone * treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization * treatment with beta interferons, glatiramer acetate, iv immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization * systemic corticosteroid therapy within 4 weeks prior to randomization
clinical applicability of robot-assisted gait training system in acute stroke patients

Conditions: Stroke

Summary: investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. it is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

stroke is not only the second leading cause of mortality in taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. however, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. it is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed hiwin robotic gait training system (mrg-p100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

Eligibility criteria:
inclusion criteria: * between the age of 20-80 years; * diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging; * paresis of a lower limb; * ability to walk for only a few meters either with or without aid. exclusion criteria: * deemed by a physician to be medically unstable; * other prior musculoskeletal conditions that affected gait capacity; * co-existence of other neurological diseases; * cognitive impairments that would impact on the safe participation in the study (mmse\<23)

Keywords: rehabilitation robotic gait quality of life
trial of linaclotide in patients with chronic constipation

Conditions: Chronic Constipation

Summary: the objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (cc). the primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for complete spontaneous bowel movement (csbm) overall responder.


Eligibility criteria:
inclusion criteria: * patient has completed a colonoscopy according to the aga criteria, with no clinically significant findings * patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ecg, or clinical laboratory tests * patient meets protocol criteria for cc: reports \ 25% of bms * patient demonstrates continued chronic constipation through pretreatment period * patient is compliant with ivrs exclusion criteria: * patient has history of loose or watery stools * patient has symptoms of or been diagnosed with irritable bowel syndrome (ibs) * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
a research study looking at similarity between once-weekly semaglutide versions for different injection pens

Conditions: Healthy Volunteers; Diabetes Mellitus, Type 2

Summary: the study will look at how two different semaglutide versions reach and stay in the blood after injection. the study aims to show similar levels of semaglutide in the blood when using the different semaglutide versions. participants will get 1 of the 2 versions of semaglutide. which version participants get is decided by chance. one version is the one that doctors already can prescribe and the other is the new version. participants will get the medicines as an injection under the skin of the stomach with the use of a pen-injector. the type of pen-injector is different for the two versions of semaglutide. the study will last for about 80-99 days. participants will have 24 study visits with the study doctor. for 2 of the visits, participants will stay in the clinic for 4 days and 3 nights. participants may have to stop the study if the study doctor thinks that there are risks for their health. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years (both inclusive) at the time of signing informed consent. * body mass index between 25.0 and 34.9 kg/m\^2 (both inclusive) and * body weight between 65.0 and 130.0 kg (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods. * any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. * use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid (the two latter are not allowed within 24 hours before screening), within 14 days prior to the day of screening. * abuse or intake of alcohol, defined as any of the below: * known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than an average intake of 24 g alcohol daily for men and 12 g alcohol daily for women) * positive alcohol test at screening * abuse or intake of drugs, defined as any of the below: * known or suspected drug/chemical substance abuse within 1 year prior to the day of screening * positive drug of abuse test at screening
multicenter rct of the clinical effectiveness of oncothermia with chemotherapy in metastatic pancreatic cancer patients

Conditions: Cancer, Pancreas

Summary: patients with pancreatic cancer often suffer from pain. because of such a pain, their quality of life have seriously deteriorated. there have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). however, there are several limitations in conventional hyperthermia. in a previous pilot study (nct02150135), we found the improvement of quality of life, function, and symptom. from this background, the investigators tried to show the effect of "oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.


Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed pancreatic adenocarcinoma * patients with radiologically identified metastasis (ct or mri) * patients with no history of previous chemotherapy * patients with ecog score 0-2 exclusion criteria: * patients who have an experience of hyperthermia treatment * patients who have a difficulty of sensing heat * patients who have a skin graft or breast reconstruction surgery * patients who have a cardiac pacemaker or an implanted metal * pregnant or breast feeding women * patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months * patients who were treated with unproved drugs within 30 days * patients who have a serious disease which can affect the person's safety * patients who do not consent to the study
study of axillary lymphadenectomy without drainage for breast cancer

Conditions: Breast Cancer; Complications; Seroma

Summary: to study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

the primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage. the secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.

Eligibility criteria:
inclusion criteria: * stage i and ii breast cancer patients * will be submitted to breast conserving therapy, with full axillary lymphadenectomy exclusion criteria: * diabetes

Keywords: breast cancer surgery complications drainage seroma