Kornimate/medical-research-clean huggingface dataset:
diurnal variation of exogenous peptides (endogenous insulin jurgita ii)

Conditions: Type 2 Diabetes Mellitus

Summary: this is an exploratory trial with two cross-over arms investigating pharmacokinetic profiles of endogenous and exogenous insulin in type 2 diabetes mellitus patients treated with continuous subcutaneous insulin aspart infusion and combined with or without intravenous glucose infusion. the order of treatment session will be randomised. hypotheses: 1. secretion of endogenous insulin depends on exogenous insulin supply 2. secretion of endogenous insulin is depends on plasma glucose levels

there are a screening visit and two treatment sessions: session a: treatment with insulin aspart 1.5 ie/time overnight without intravenous glucose infusion session b: treatment with insulin aspart 1.5 ie/time overnight with intravenous glucose infusion.

Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * insulin-naive patients * hba1c \< 9% * women and men \>= 35 and \<= 75 years old * bmi 25-42 kg/m2, both values are included exclusion criteria: * suspected or known allergy to the trial drug or similar medications * treatment with hte drugs that after investigator judgment could potentially interfere with plasma glucose levels * heart: unstable angina pectoris, acute myocardial infarction within the last 12 months * severe uncontrolled hypertension with blood pressure in lying position \> 180/110 mmhg * impaired liver function with liver parameters more than 2 times above the upper normal limit according to the local laboratory * impaired kidney function with egfr \< 50 ml/min according to the local laboratory * pregnancy, lactation or desire for pregnancy in the study period and for women in childbearing age without adequate contraception-adequate contraception is: sterilisation, hysterectomy or current use of contraceptive pills, coil, gestagen depot injection, subdermal implantation, hormonal vaginal ring and transdermal depot patch.

Keywords: type 2 diabetes mellitus, endogenous insulin
a comparison between bandage contact lens, punctal plugs and standard measures in preventing corneal injuries

Conditions: Contact Lens and Punctal Plug in Preventing Corneal Injuries

Summary: study rationale: the insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the icu may be more effective than standard care in decreasing the incidence of corneal injuries. study objectives: 1. to document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the icu. 2. to assess the safety of a contact bandage lens and punctal plug in critically ill patients.

this is a prospective, randomized study study population: consecutive patients admitted to the general intensive care unit of the rabin medical center and sharon hospital medical center over a 6-month period who meet criteria for inclusion. procedures: consecutive patients meeting inclusion criteria will be enrolled in the study. patients will be randomized to 3 groups: the bandage contact lens group, who will be assigned to insertion of a bandage contact lens; the punctal plug group, who will be assigned to the insertion of punctal plugs; and the control group, who will be assigned to standard eye care as currently practiced in the icu. in addition, patients in the study will be examined every 4 days by a physician from the ophthalmology department and at either discharge from the icu or at time of death.

Eligibility criteria:
inclusion criteria: - patients must be \> 18 years of age. patients who meet the following criteria will be considered eligible for the study: i) require mechanical ventilation; ii) require continuous infusion of sedative medication with or without neuromuscular paralysis; iii) anticipated icu stay \> 5 days. exclusion criteria: - patients will be excluded if there is any preexisting corneal disease or an ophthalmic injury related to the present admission (e.g. ophthalmic trauma) to the icu.

Keywords: critically ill patients punctal plug corneal injuries
virtual group psychoeducational discussions with spanish-speaking mothers of infants in pediatric primary care

Conditions: Postpartum Depression; Postpartum Anxiety

Summary: the goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to spanish-speaking parents of newborns/infants attending pediatric primary care. the virtual session is intended to (1) enhance patient/family education about postpartum depression (ppd) and (2) provide an orientation to families regarding relevant clinic and community psychosocial support resources available. the investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). session contents include (1) introduction to clinic staff, contacts, and resources (2) a video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) review of prevalence and signs of ppd; (4) discussion of clinic ppd screening procedures and rationale for screening; (5) discussion of self-care and mood monitoring; (6) discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. the overall aim of the project is to develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement


Eligibility criteria:
inclusion criteria: * parent participants will be eligible if the preferred healthcare language is spanish, if they are the mother of an infant (\<2 months of age) attending participating pediatric practice, and if she is not felt to have a contraindication to participation (e.g., condition in the parent that would preclude the ability to reasonably participate in a virtual group session) by clinic staff * clinic staff participants - facilitators of virtual groups exclusion criteria: * \<16 years old, preferred healthcare language not spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion
the effectiveness of the "mindling" digital mental health intervention

Conditions: Mental Health Services; Personality

Summary: a study in south korea assessed the effectiveness of the "mindling" digital mental healthcare program, targeting maladaptive personality traits, and found significant improvements in reducing stress, perfectionism, loneliness, and anxiety, while increasing self-esteem among participants. the study highlights the potential of digital solutions to address the high demand for mental healthcare services in south korea.

this study conducted a randomized controlled trial to evaluate the effectiveness of a digital intervention program called "mindling" designed to target maladaptive personality traits, with four subprograms addressing perfectionism, low self-esteem, social isolation, and anxiety. participants were assigned to one of these programs, and primary outcome measures varied accordingly, including the perceived stress scale, hewitt multidimensional perfectionism scale, state self-esteem scale, ucla loneliness scale, and beck anxiety inventory. the study anticipated treatment effects in both primary and secondary outcome measures for the treatment group compared to the waitlist group after 5 and 10 weeks of intervention.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18 and 60 * experiencing a moderate level of stress in their daily lives (pss≥17) and meet a certain level of perfectionism (hmps≥198), self-esteem (sses≤57), loneliness (ucla ls≥47), and anxiety (bai≥16). the cutoff points for each scale are based on the top or bottom 25% of the frequency distribution suggested in the previous study. exclusion criteria: * in cases where there is difficulty understanding and reading korean.

Keywords: digital mental health service intervention randomized controlled trial personality focused
cocaine/crack and reduction of compulsion with biperiden

Conditions: Cocaine Dependence

Summary: considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (ach) may play an important role on cocaine dependence process. then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.

cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. the drug dependence has been described by many authors as a dysfunction of the brain reward system. considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (ach) may play an important role on cocaine dependence process. then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. to accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. this is a double-blind controlled and randomized placebo study. all the patients will be treated with brief intervention therapy (bit), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. the treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: craving scale of minnesota and cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Eligibility criteria:
inclusion criteria: * cocaine or crack dependence, according to the dsm-iv criteria (apa, 1994) exclusion criteria: * being under treatment with psychoactive drugs * have been diagnosed for other psychiatric disorders * have dependence diagnosis for other drugs, except for tabacco

Keywords: cocaine crack treatment dependence biperiden
immunogenicity and safety study of glaxosmithkline biologicals' poliorix™ vaccine

Conditions: Poliomyelitis; Poliomyelitis Vaccines

Summary: the purpose of the study is to evaluate the immunogenicity and safety of poliorix™ when administered to healthy chinese infants at 2, 3 and 4 months of age.


Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination. * born after a gestation period of 36 to 42 weeks inclusive. * subjects who the investigator believes that their parent(s)/legally acceptable representative (lar) (s) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of dtp, hib and/or hepatitis b vaccine(s). * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent poliomyelitis disease or vaccination. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. * child in care. the following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met: • current febrile illness or axillary temperature \> 37.0 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: poliorix ipv
a multi-center, double-masked, randomized, vehicle-controlled, parallel-group clinical trial evaluating the safety of reproxalap ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: a multi-center, double-masked, randomized, vehicle-controlled, parallel-group clinical trial evaluating the safety of 0.25% reproxalap ophthalmic solution in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: * 18 years of age (either gender and any race); * reported history of dry eye for at least 6 months prior to visit 1; * history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1. exclusion criteria: * clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * contact lens use within 7 days of visit 1 or anticipate using contact lenses during the trial; * eye drop use within 2 hours of visit 1; * previous laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of visit 1; * planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of visit 1; * temporary punctal plugs during the study that have not been stable within 30 days of visit 1.
evaluation of reactogenicity and safety of gsk biologicals' rotarix (human rotavirus vaccine) in infants

Conditions: Infections, Rotavirus

Summary: this protocol posting deals with objectives and outcome measures of the primary phase at one month post-dose 2. this post marketing surveillance (pms) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in korea. this study involves male or female infants from the age of 6 weeks at the time of the first vaccination. the vaccination course must be completed by the age of 24 weeks.

the protocol posting has been amended to reflect the two new vaccine presentations that have been launched in korea. the current pms will thus collect safety information from subjects who have received either rotarix or rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in korea.

Eligibility criteria:
inclusion criteria: * infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the pms. * a male or female infant from the age of 6 weeks at the time of the first vaccination. * written informed consent obtained from the parent or guardian of the infant. exclusion criteria: • at the time of pms entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the pms if there is any contraindication. any changes in the locally approved prescribing information must be implemented immediately.

Keywords: gastroenteritis
a open-label prospective cohort trial of curcumin plus tyrosine kinase inhibitors (tki) for egfr -mutant advanced nsclc

Conditions: Lung Cancer

Summary: the purpose of this study is is to assess the safety and tolerability of curcumin in combination with egfr-tkis in selected patients with advanced non-resectable mutant egfr nsclc.

this is a phase 1 open prospective cohort study to assess the safety and feasibility of using curcumin in conjunction with an egfr-tki in patients with advanced nsclc. the investigators will use an enhanced bioavailable formulation of curcumin (curcuviva tm at 80 mg/ 1 capsule per day) approved and licensed by health canada (npn 80027414) that has been shown to have 2-3 times higher curcumin concentration in the blood as compared to previous clinical trials. as primary objective, the investigators will recruit 20 patients for a duration of 8 weeks to monitor adverse effects according to the the national cancer institute common terminology criteria.exploratory objectives would include assessing changes in health-related quality of life using the standardized fact-l questionnaire and evaluating anti-inflammatory properties of curcumin by measuring crp. if tolerable safety data is obtained, an expanded phase ii trial will be designed.

Eligibility criteria:
inclusion criteria: * newly diagnosed or patients on treatment for histologically confirmed advanced egfr-mutant nsclc defined as unresectable stage 3a, stage 3b or stage 4. * the egfr mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). any egfr mutation-positive result must be documented and the analysis for the mutation will be performed using the jgh local testing methodology. * receiving concurrent egfr-tki therapy. * eastern cooperative oncology group (ecog) performance score 0-3 exclusion criteria: * symptomatic brain metastases. * patients who are receiving any other investigational agents. * patients using other non-vitamin or mineral regular natural health product, which includes chinese herbs. * incapacity to understand and sign a written informed consent document in english/french. * pregnancy

Keywords: curcumin lung cancer tki
guardant360® related clinical outcomes in patients who share medical records-breast cancer

Conditions: Advanced Breast Cancer

Summary: the purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone guardant360 testing.

patients who have been diagnosed with breast cancer and have undergone guardant360 testing will be approached regarding participation in the study. after being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. data related to their routine clinical care will be abstracted from medical records.

Eligibility criteria:
inclusion criteria: 1. adults (18 years of age and older) with a diagnosis of breast cancer 2. guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact 3. patient has previously provided contact information (either email or phone) to guardant health 4. able and willing to complete the electronic informed consent process 5. must have access to a computer terminal or personal computing device 6. willingness to consent to the release of medical records exclusion criteria: 1. unable to understand english
a study of ly3316531 in healthy participants and in participants with psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate how well ly3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. the study drug will be administered either subcutaneously (sc) (under the skin) or intravenously (iv) (into a vein in the arm). this is a three-part study. participants will enroll in only one part. parts a and b are for healthy participants and part c is for participants with psoriasis. participation could last between 16 and 57 weeks.


Eligibility criteria:
inclusion criteria: * healthy participants * are overtly healthy males or females, as determined by medical history and physical examination * females must be of non-childbearing potential * are between 18 and 64 years of age, inclusive, at screening * have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * psoriasis participants: * chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline * meet psoriasis disease activity criteria * are at least 18 years of age * have a minimum body weight of 50 kilograms (kg) exclusion criteria: * healthy and psoriasis participants * have known or ongoing neuropsychiatric disorders * have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study * have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline * show evidence of active or latent tuberculosis (tb) * have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data * psoriasis participants only: * have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy) * prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval * have received systemic nonbiologic psoriasis therapy within 28 days of baseline * have received topical psoriasis treatment within 14 days of baseline