Kornimate/medical-research-clean huggingface dataset:
a study to evaluate rebif® new formulation (interferon-beta-1a) in relapsing remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: general note: throughout this record, "rebif® new formulation" is used for historical and consistency purposes. objectives: primary: to evaluate the efficacy of rebif® new formulation (interferon-beta-1a \[ifn-beta-1a\], rnf), compared to placebo, in subjects with relapsing remitting multiple sclerosis and active disease by means of magnetic resonance imaging (mri) at the end of 16 weeks of treatment secondary: to evaluate the efficacy of rnf by comparing the mean number of combined unique (cu) lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of rnf treatment in the same subjects, originally randomized to placebo. primary endpoints: the primary endpoint is the difference between the number of cu active mri lesions at week 16 in the rnf group (group 1) versus the placebo group (group 2). secondary endpoints: the secondary endpoint is the difference in the mean number of cu active mri lesions per scan per subject over the following treatment periods: study day 1 - week 16 versus weeks 17 - 40 for the subjects randomized to group 2.


Eligibility criteria:
inclusion criteria: * males and females between 18 and 60 years of age * female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study * have relapsing remitting multiple sclerosis (rrms) according to the revised mcdonald criteria 2005 * have brain and/or spinal mri with findings typical of multiple sclerosis (ms) * have disease duration for more than 12 months * have disease activity characterized by at least one clinical event and one or more gadolinium-enhancing mri lesions within the 6 months prior to randomization * have score of \<=5.5 on the expanded disability status scale (edss) * be willing and able to comply with the protocol for the duration of the study * have given written informed consent prior to any study-related procedure not part of the normal medical practice exclusion criteria: * have any disease other than ms that could better explain his/her signs and symptoms * have complete transverse myelitis or bilateral optic neuritis * have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone \[acth\]), or total lymphoid irradiation * have received within 3 months prior to baseline any approved disease-modifying therapy for ms, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure * have received within 30 days prior to baseline oral or systemic corticosteroids or acth * other protocol defined exclusion criteria could apply

Keywords: subjects with relapsing remitting multiple sclerosis
lymph node mapping using indocyanine green solution in diagnosing patients with malignant melanoma

Conditions: Recurrent Melanoma

Summary: this clinical trial compares and contrasts lymph node mapping using indocyanine green (ic-green), isosulfan blue (isb), and tsc and lymphoscintigraphy with 99-technetium (99tc) sulfur colloid (tsc). study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

primary objectives: i. to show that indocyanine green (icg) (indocyanine green solution) is equal to both isosulfan blue (isb) and technetium tc 99m sulfur colloid (tsc) and will allow all lymph node mapping to occur in the operating room (or). outline: patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. during surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (spy elite camera).

Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign informed consent document * signed written informed consent * malignant melanoma (mm) undergoing sentinel lymph node biopsy (snlb) * 18 years of age or older * complete blood count (cbc) and metabolic panel within 6 months exclusion criteria: * history of hepatic or renal failure * allergy to iodine containing products * pregnant or may be pregnant * psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements * undergoing dialysis
the effectiveness and cost-effectiveness of mental wellness youth hub

Conditions: Mental Stress

Summary: the proposed study is to be carried out with 6000-7000 youths aged 12 - 24 in hong kong. the purpose of the study is to investigate the effectiveness and cost-effectiveness of a hub project for young people: levelmind@jc. this study is conducted by levelmind@jc in collaboration with partnering ngos including the boys' \& girls' clubs association of hong kong (bgca), caritas hong kong, hong kong federation of youth's group (hkfyg), hong kong playground association (hkpa), hong kong children and youth services (hkcys) and st james' settlement (sjs). it is a 1-year quasi experimental controlled study which aims to examine if these hubs can enhance young people's cognitive abilities, personal strengths and overall mental well-being. 1800 participants would be recruited, including 600 hub users, 600 non-hub users (but receiving services from participating ngos), and 600 community youth not receiving any youth services. participants will be assessed at baseline and follow-ups (e.g., 3 months, 6 months, and 12 months); completing questionnaires and answering questions during a 3- hour interview. hub users with mild to moderate mental distress will receive different psychological treatments according to their needs. for youths who are at risk for mental disorders, diagnostic and medical assessment services will be delivered by psychiatrists or clinical psychologists. findings will allow us to better understand the effectiveness of this kind of community-based hubs for young people, improve mental wellness training of youth social workers; and in a long run, develop a community-based support model that is sustainable, scalable and replicable.


Eligibility criteria:
inclusion criteria: * for hub-user group (experimental group): 12 - 24 year- old hub users who receive community-based mental wellness youth hub services for young people. * for non-hub user group (active control group): 12 -24 year- old youths who do not receive the community-based mental wellness youth hub services but other generic youth services in the community. * for non-hub user group (passive control group): 12 -24 year- old community youth who do not receive any youth services in the community. exclusion criteria: * youths with known diagnosis of psychiatric disorders (including depression, generalized anxiety disorder, panic disorder, phobia, obsessive compulsive disorder, bipolar disorder, eating disorder, personality disorder, post-traumatic stress disorder and psychotic disorder) * youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs) * youths who have limited comprehension due to epilepsy or mental retardation.

Keywords: youth mental health
mhealth insulin titration and management (isage)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine the benefits of using the isage app for basal insulin titration and support. by doing this study the investigators hope to learn whether the app improves the participant's ability to follow his/her healthcare provider's instructions to adjust his/her insulin doses.


Eligibility criteria:
inclusion criteria: * diagnosed type 2 diabetes, based on the world health organization (who) criteria, treated with basal insulin * hba1c 8-11% inclusive * glomerular filtration rate (gfr) \> 60 ml/min * has an android or ios based compatible smartphone (ios 9.0 or above, android 4.4 or above) * willing to perform at least 1 fasting finger stick glucose measurements every morning * english speaking exclusion criteria: * diagnosis of hypoglycemic unawareness * diagnosis of hyperglycemic hyperosmolar non-ketotic coma (honk) or diabetic ketoacidosis (dka) within 6 months of enrollment * recent (within the last 6 months)/current use of non-topical steroids * insulin requirements in excess of 1 u/kg per day * use of pioglitazone or another thiazolidinedione (tzd) * in the opinion of the provider, hgba1c goals should be adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.
chronotherapy versus conventional bp control to correct abnormal circadian bp pattern in kidney transplant recipients

Conditions: Blood Pressure Control; Kidney Transplant Recipient

Summary: the purpose of this study is to identify and manage factors related to blood pressure control that impact organ function and survival in kidney transplant recipients. loss of the circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. it is still unclear if restoring the normal day-night blood pressure (bp) pattern will translate into better allograft outcome. although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal (night) dipping in bp is possible by changing the timing of the bp medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients.

the challenge in kidney transplantation is to identify and manage factors that impact allograft function and survival. loss of the circadian blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. nevertheless, it is unclear if restoring the normal day-night bp pattern will translate into better allograft outcome. although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal dipping in bp is possible by changing the timing of the bp medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients. this exploratory study is driven by the hypothesis that chronotherapy will restore the normal circadian bp pattern and will translate into better allograft function and into lower lvm 1-year from transplantation.

Eligibility criteria:
inclusion criteria: * recipient of a kidney transplant. * age≥18 years. * stable allograft function. * ability to give informed consent. exclusion criteria: * multiorgan transplant recipients. * kidney transplant recipients with poor allograft function. * documented history of obstructive sleep apnea.

Keywords: kidney transplantation hypertension chronotherapy graft function circadian pattern
the corona and covid-19 study in telemark and agder

Conditions: Covid19

Summary: through sars-cov-2 igg testing of pcr positive and negative cases the study will follow the covid-19 immune response by monitoring the sars-cov-2 igg antibody levels over a period of two years. further, risk factors will be identified by the use of the test-negative design including population controls, allowing comparison of participants with positive and negative tests, and with population controls (triangulation). special emphasis will be on high risk groups in general and on different occupational, environmental and socio-economic groups in particular. finally, severity of illness, deaths and the use of health care during will be assessed using national register data from telemark and agder.

objectives the main objectives are: 1. monitor the incidence of covid-19 and the development of the sars-cov-2-igg levels of cases in agder and telemark over a period of two years (wp1). 2. identify risk factors for covid-19 by comparison of sars-cov-2 antibody positive and negative cases in telemark and agder, and comparison of these groups separately with population controls (wp2). 3. the incidence of neurocognitive symptoms and fatigue in covid-19 patients (wp3). 4. investigation of severity, death and the use of health care for the covid-19 patients based on data from national registers (wp4). the main exposures are (wp1-3): * infection (mild, severe) with covid-19. * occupational risk factors assessed by occupational codes (isco88) and job exposure matrix categorisation. * environmental risk factors (road traffic outside bedroom window, travel by foot or bicycle alongside busy roads, and the use of a fireplaces in residential homes. further, estimated measurements of air pollution may be linked to participants' home address. * socioeconomic status; age, sex, comorbidity, medication use, lifestyle factors (smoking, bmi, physical activity, others), geographic region/municipality, education and income.

Eligibility criteria:
inclusion criteria: * age 18 - 85 years * performed sars-cov-2 pcr test exclusion criteria: * non-norwegian speakers. * deceased * inability to answer questionnaire due to dementia or similar conditions

Keywords: immunity risk factors test-negative design population controls
prophylactic use of cranberries in recurrent bacterial cystitis in women

Conditions: Recurrent Urinary Tract Infections in Women

Summary: to investigate if oral administration of 240mg pac of cranberries can reduce the number of episodes of acute bacterial cystitis and improve general qol in women with recurrent bacterial cystitis. in addition, the effect on vagina and rectal flora will studied and the adverse effect profile of the drug will be reported. women with ≥3 symptomatic episodes of lower utis at the previous year will be recruited from the outpatient population who present to their family physician or specialist with symptomatic recurrent uti. informed consent will be obtained from all patients and they will be divided in groups according to their age. urinary culture, vaginal and rectal swab will be taken from all the patients. antibiotic treatment will be prescribed (using the drug of choice according to the urine culture and the treating physician choice). subsequently, they will be randomized to receive combined antibiotic treatment with one capsule of cysticlean 240mg pac two times per day or antibiotic treatment with placebo. at 14th day post treatment and after a negative urinary culture patients will continue to receive per os, daily, one capsule of cysticlean 240mg at bed time for 12 months or placebo respectively. study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. a urine collection, vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12 visits. participants will be asked about medication usage, any side effects they may be experiencing at each study visit. if participants develop a uti at any time during the study, they will be asked to visit the study site within 24 hours.


Eligibility criteria:
inclusion criteria: * negative urine culture * at least 3 uti's within 12 months prior to study entry exclusion criteria: * anatomic abnormalities of the urinary tract * use of investigational drugs within 30 days prior to study entry * current use of warfarin * allergy or intolerance of cranberry products * \> 50 ml of residual urine (measured by us) * use of indwelling catheter * uncontrolled diabetes * creatinine \> 250 mmol/l, * symptomatic vaginitis * pregnant or breastfeeding
assessment of robotic assistance on gait parameters among healthy subjects and brain damaged patients

Conditions: Stroke

Summary: the main objective of this study is to quantitatively assess the robotic assistance given by an exoskeleton on patients gait parameters. patients will be asked to walk with- and without the exoskeleton on a treadmill. during the study, the biomechanical and the energy consumption will be assessed.


Eligibility criteria:
inclusion criteria: * hemiparesis due to stroke * min 18 years * time since stroke \> 15 days * ability to understand instructions * ability to do gait analysis on the treadmill exclusion criteria: - contraindication for the use of the robot atalante
phase 1 biomarker study of anti-pdl-1 in advanced melanoma

Conditions: Stage III or IV Melanoma

Summary: the purpose of this study is to evaluate pharmacodynamic changes of bms-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable stage iii or iv melanoma.


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years * eastern cooperative oncology group (ecog) status = 0 to 1 * subjects with unresectable stage iii or iv melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma * subject must have histologic or cytologic confirmation of advanced melanoma * subjects must have at least one measurable lesion at baseline by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors (recist) 1.1 criteria * subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies exclusion criteria: * active or progressing brain metastases * other concomitant malignancies (with some exceptions per protocol) * active or history of autoimmune disease * positive test for human immunodeficiency virus (hiv) 1\&2 or known acquired immunodeficiency syndrome (aids) * history of any hepatitis * prior therapy with any antibody/drug that targets the t cell coregulatory proteins, including but not limited to, anti programmed cell death 1 (pd-1), anti programmed cell death ligand 1 (anti-pd-l1), anti-pd-l2, anti-cd137, anti-ox-40, anti-cd40 or anti cytotoxic t lymphocyte-associated antigen 4 (anti-ctla-4) antibodies
spinal cord analysis in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: research project in which patients with multiple sclerosis (ms) are examined clinically and with magnetic resonance imaging (mri). to evaluate spinal cord (sc) grey and white matter changes (incl. lesions) using fast, high-resolution mri sequences with high contrast between sc and cerebrospinal fluid (csf) as well as high contrast within the sc (grey-white matter contrast).

the swiss multiple sclerosis cohort (smsc-study) aims to better evaluate specific multiple sclerosis (ms) phenotypes through the systematic and standardised documentation and acquisition of clinical course and paraclinical tests such as magnetic resonance imaging (mri), blood and cerebrospinal fluid (csf) specimens. determination of the relative contribution of sc metrics (cervical cord volume, cervical grey matter (gm) cord volume, cervical white matter (wm) cord volume, sc lesion load) to disability in ms.

Eligibility criteria:
inclusion criteria * diagnosis of multiple sclerosis * steroid free period: \> 4 weeks * healthy controls without any history of severe neurological, internistic or psychiatric disease exclusion criteria for all participants: * history of severe (other) neurological, internistic or psychiatric disease * mri related exclusion criteria: 1. paramagnetic and/or superparamagnetic foreign objects in the body 2. pacemaker 3. claustrophobia 4. pregnancy, lactation

Keywords: spinal cord spinal cord atrophy cerebrospinal fluid swiss multiple sclerosis cohort
cardiac adverse reactions related to immune checkpoint inhibitor in nsclc patients

Conditions: Adverse Reactions; Immune Checkpoint Inhibitor; Non-Small Cell Lung Cancer Patients; Cardiac Event

Summary: this is a prospective, open label, single arm study. a total of 300 patients with primary non-small cell lung cancer treated with pd-1/pd-l1 immune checkpoint inhibitors(icis) are expected to included . all patients will follow up for at least 1 year. patients with cardiac adverse reactions after pd-1/pd-l1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. patients with odd random number will treat with rasi（renin-angiotensin system inhibitors）, and those with even random number will treat with arni（angiotensin-receptor-neprilysin inhibitor）.


Eligibility criteria:
inclusion criteria: 1. be willing and able to provide written informed consent/assent for the trial; 2. lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage iii\~iv; 3. patients received with icis treatment, including anti-pd-1 or anti-pd-l1 for at least two courses; exclusion criteria: 1. patients who do not have pathological diagnosis; 2. patients who can't finish the follow-up; 3. the anti-pd-1, anti-pd-l1 therapy was less than two courses; 4. patients whose cancer diagnosed with small cell lung cancer.
comparison of joint mobility levels and performance in young male basketball players and sedentary peers

Conditions: Hypermobility, Joint

Summary: the aim of our study was to determine the joint mobility levels and its effects on performance in male basketball players and their sedentary peers aged 16-22 years. according to the studies on the effect of hypermobility on the performance; the young athletes who played tennis had lower equilibrium results than those without hypermobility. although there is not any study that investigate its effects in basketball, there are studies for tennis and volleyball in literature.


Eligibility criteria:
inclusion criteria: for players: * being a healthy male between the ages of 16-22, * playing basketball for at least 1 year, * body mass index \<30, * volunteer to participate in research. for sedentary peers: * being a healthy male between the ages of 16-22, * international physical activity questionnaire short form score \<600 met-min/week, * body mass index \<30, * volunteer to participate in research. exclusion criteria: * to have a musculoskeletal problem which prevents the person from exercising, * having a cardiovascular system disorder that limits exercise capacity * neurological disorder or cognitive dysfunction * smoking

Keywords: basketball sedentary joint mobility performance
effects of nonsteroidal anti-inflammatory drug (nsaid) on inflammatory lesion of axial spondyloarthritis

Conditions: Spondylarthropathies; Magnetic Resonance Imaging

Summary: axial spondyloarthritis (spa) is a kind of inflammatory arthritis which includes ankylosing spondylitis. common symptoms of axial spa are inflammatory back pain, morning stiffness, peripheral arthritis, enthesitis. controlling aforementioned symptoms are one of the goal in treatment, and another goal is preventing bony ankylosis of axial skeleton such as spine. ankylosis can limit range of motion and lower the quality of life. non-steroidal antiinflammatory drug (nsaid) and tumor necrosis factor (tnf)-a inhibitor are the current treatment options for axial spa. these medications can improve pain and stiffness of axial spa patients, however preventing bony ankylosis is not proven. current study showed attenuating inflammation at early stage could prevent further bony destruction and ankylosis in axial spa. present study is designed to discover the therapeutic effect of nsaid whether nsaid could recover the early inflammatory bony change (bone marrow edema at mri) and prevent further bony change.


Eligibility criteria:
inclusion criteria: 1. 2009 assessment of spondyloarthritis international society (asas) classification criteria for axial spondyloarthritis 2. bath ankylosing spondylitis disease activity index (basdai) \> 4 3. definite bone marrow edema on sacroiliac joint mri exclusion criteria: 1. patients who have underling cancer / infectious disease / kidney disease / liver disease / cardiovascular or cerebrovascular disease 2. patients who is using tnf-a inhibitor 3. patients with side effects of nsaid 4. patients with history of peptic ulcer 5. patients who can't keep nsaid treatment