Kornimate/medical-research-clean huggingface dataset:
neuropsychological and neuroanatomical studies of young children with and without type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this study is being conducted to see if type 1 diabetes mellitus has any affect on learning, behavior and development in young children and whether there are associated changes on their mri scan.

in this pilot study approximately 10-20 children between the ages of 3 to 10 years with type 1 diabetes mellitus will have neuropsychological testing and a nonsedated mri scan of the head performed every three years for three years. we will compare this to a control group of 10 children between the ages of 3 adn 10 years without type 1 diabetes mellitus. the control subjects will neuropsychological testing and a nonsedated mri scan of the head once. the children with type 1 diabetes mellitus will not have any changes made to their current diabetes regimen.

Eligibility criteria:
inclusion criteria: inclusion criteria for study subjects: * to be between ages 3 to 10 years * have been diagnosed with type 1 diabetes for at least 6 months; and * do not have plans to move out of the area within the next 36 months. inclusion criteria for control subjects: * to be between ages 3 to 10 years exclusion criteria: * no history of head trauma with any loss of consciousness, * cystic fibrosis, * prematurity (born less than 30 weeks of gestation), * significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age), * neurologic disease independent of diabetes (eg seizure disorder); or * medical contraindication to mri procedure (eg metal appliances such as braces).

Keywords: type 1 diabetes mellitus
penn state txt2quit study

Conditions: Nicotine Dependence, Cigarettes

Summary: this study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to varenicline in a primary care setting.


Eligibility criteria:
inclusion criteria: * smoke \>4 cigarettes/day for at least 6 months * age 21+ * want to quit and ready to try in next 30 days * willing to quit all forms of tobacco (including e-cigs) * willing to use chantix to try to quit * have a cell phone able to receive text messages * willing to attend 3 visits and use varenicline for smoking cessation * plan to live in local area for next 6 months * read and write in english * women not pregnant and taking steps to avoid * able to understand and willing to sign consent exclusion criteria: * history of allergic reaction or other adverse event while using varenicline * used a smoking cessation aid/medicine in past 1 month (including e-cigs) * currently pregnant or nursing * does not have a mobile phone that can send and receive text messages or unwilling to receive study texts * uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months * uses non-cigarette tobacco products and does not plan to quit all tobacco. * has a history of kidney problems or receives dialysis * had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks * had a heart attack in the past 4 weeks * mental conditions that would prohibit the participant from completing the protocol
patient expectations and dry needling

Conditions: Neck Pain

Summary: dry needling (dn) is a treatment technique used for treating musculoskeletal pain conditions. dn has shown to be effective on pain and function in patients with mechanical neck pain. potential effects of dn can be related to several mechanisms, including physical, cognitive and emotional factors. this study will evaluate the role of the patient expectances related to the evolution (progress) of the condition, in this case, mechanical neck pain, in the effects of real or sham dry needling in sensitivity outcomes such as pain intensity or pressure pain sensitivity. expectation of each patient in both groups will be considered positive, neutral or negative based on the outcomes of the patient shoulder expectancies (psoe) questionnaire which was adapted to the cervical spine.


Eligibility criteria:
inclusion criteria: * non-specific mechanical neck pain of at least 3 months of duration * at least one active trigger point in the upper trapezius muscle which referred pain reproduces the neck pain symptoms exclusion criteria: * whiplash injury; * previous cervical or thoracic surgery; * cervical radiculopathy or myelopathy; * diagnosis of fibromyalgia syndrome; * having undergone physical therapy in the previous 6 months; * fear to needles

Keywords: neck pain needling expectance
ipatasertib (gdc-0068) study to evaluate formulation change and food effect on bioavailability in healthy subjects

Conditions: Cancer

Summary: this phase i, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. in addition, the influence of food on ipatasertib exposure will also be determined. participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. time on study is expected to be 3 weeks.


Eligibility criteria:
inclusion criteria: * healthy males or females, between 18 and 55 years of age, inclusive * body mass index between 18.5 and 29.9 kg/m\^2, inclusive exclusion criteria: - clinically significant findings from medical history or screening evaluations.
safety and efficacy of activated recombinant human factor vii in haemophilia patients with inhibitors during and after major surgery

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted in north america. the aim of this trial is to compare the safety and efficacy of activated recombinant human factor vii in patients with haemophilia a or b undergoing major surgical procedures.


Eligibility criteria:
inclusion criteria: * have haemophilia a or b with inhibitors to factor viii or ix, respectively * have had a historical inhibitor level of at least five bethesda units or have had an inadequate haemostatic response to 250 u/kg of factor viii or ix or have had an inadequate response to feiba * require pre-planned major surgery in hospital exclusion criteria: * have participated in or have been treated with any investigational drug other than activated recombinant human factor vii within the last thirty days * have been treated with any haemostatic agent, including rfviia, within 48 hours of preoperative dose * have any haemostatic disorder other than haemophilia
executive function in obese

Conditions: Obesity

Summary: this study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.


Eligibility criteria:
inclusion criteria: for the study group; * individuals volunteering for the study with bmi ≥30 kg/m2 * individuals between the ages of 18-65 who volunteer to work * individuals who scored 21 points and above in the cognitive assessment for the control group; * individuals volunteering for the study with bmi ≥30 kg/m2 * individuals between the ages of 18 and 65 who are willing to work * scoring less than 21 points on the cognitive assessment exclusion criteria: * being at a mental level that cannot understand and answer the questions posed * having a diagnosed neurological disease * having had cancer within the last 2 years * having major organ dysfunction * having uncontrolled type 2 diabetes * loss of vision, hearing

Keywords: obesity executive functions physical performance well-being
ise-santé, a study evaluating a model for implementing e-health in the management of hiv patients

Conditions: HIV; Telemedicine

Summary: it is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic hiv infection at cayenne hospital. the main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.

the covid-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. in this context, e-health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with covid 19, to protect patients and caregivers and avoid nosocomial infections. telemedicine is all the more relevant in guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. in french guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak french and having restricted access to digital technology. moreover hiv infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment. the study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic hiv infection at cayenne hospital : 1/ control group with classic follow-up at cayenne hospital. 2/teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). number of patients to be included: 450 patients.

Eligibility criteria:
inclusion criteria: * patients with chronic hiv infection. * patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the cayenne hospital center. * patient of legal age. * patient having signed the consent form.. exclusion criteria: * pregnant patient * patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability). * patient with a physical disability that prevents communication via the e-health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient). * patient who does not master one of the languages available at the mediation. * patients under guardianship or trusteeship, people under protective measures
a study to compare fkb327 efficacy and safety with humira® in rheumatoid arthritis patients

Conditions: Arthritis, Rheumatoid

Summary: the purpose of the study is to compare the effectiveness and safety of fkb327 in comparison to humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or over 2. patients have been diagnosed with rheumatoid arthritis (ra) for at least 3 months 3. patient has active ra 4. patient has taken a stable dose of methotrexate for at least 3 months exclusion criteria: 1. patient has been previously treated with adalimumab 2. patient has been previously treated or has ongoing treatment with prohibited medications 3. patient has been immunised with a live or attenuated vaccine in past 4 weeks 4. patient has positive result for hiv, hbv, hcv or tb infection other inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis
making decisions about depression medications

Conditions: Depression

Summary: the purpose of this study is to determine whether the depression medication choice decision aid is effective in involving patients with depression in making deliberate choices when considering medication treatment.

to determine the ability of decision aids to effectively translate a depression comparative effectiveness research (cer) review into practice, the investigators have developed a literacy-sensitive depression treatment decision aid, depression medication choice, which adapts the agency for healthcare research and quality (ahrq)'s effective healthcare comparative effectiveness review and associated patient guide about antidepressant medicines to satisfy the needs of clinicians, patients, and other major stakeholders. the investigators will conduct a randomized study to estimate the effect of the decision aid on patient knowledge, patient involvement in decision making and decision-making quality, and on three and six-month measures of medication adherence and mental health, when compared with usual care.

Eligibility criteria:
inclusion criteria: * presumed diagnosis of depression (phq-9 of 10 or greater) * as judged by clinician, need to initiate drug treatment for depression * identify primary care clinician as main depression provider * agree to be available for follow-up survey 6 months after treatment decision exclusion criteria: * has prior diagnosis of bipolar disorder * has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in same language)

Keywords: comparative effectiveness research decision support techniques decision making
3d personalized modelization of the hand using eos imaging system

Conditions: Hand Injuries

Summary: this study aims to compare the quality of 3d hand modelization with eos imaging with gold-standard computed tomography


Eligibility criteria:
inclusion criteria: * patient with hand/wrist ct required * informed consent form signed
performance of systane pro versus refresh optive mega-3

Conditions: Dry Eye

Summary: single site, prospective, double-masked, randomized-controlled, cross-over study of the subjective and objective performance of 2 different eyedrops. subjects will be assessed at a screening visit, and 3 follow-up visits. clinical evaluations will include patient questionnaires.


Eligibility criteria:
inclusion criteria: * subjects who currently have moderate symptoms of dry eye as defined by a baseline osdi score of 23-32 inclusive. * subjects between ages of 18-65 inclusive. * subjects who do not currently wear contact lenses. * subjects willing to fill out a daily diary during the duration of the study. * subjects willing to comply with the prescribed regimen and schedule of eye drops. * subjects willing to attend all study visits. exclusion criteria: * have an ophthalmologic diagnosis of: allergy, viral or bacterial conjunctivitis, anterior blepharitis, parasitic infestations in any ocular structure or its adnexa, unresolved ocular trauma, ocular surface scarring diseases, corneal or conjunctival ulcers, filamentous keratitis, neurotrophic keratitis, bulous keratopathy, neoplastic diseases on the ocular surface or adnexa, diseases with fibrovascular proliferations on the conjunctival and/or corneal surface, retinal and/or posterior diseases that require treatment or threaten the visual prognosis, or glaucoma. * eyelid disorders that cause eyelid malposition, limit adequate eyelid closure or opening or cause epiphora. * history of herpetic keratitis or ocular surgery. * have dry eye management that requires the implementation of any treatments (except artificial tears) of stage 2 of the recommendations in the treatment and management by stages for the dry eye disease of the tfos dews i\| (tear film and ocular surface society dry eye workshop i). * have a history of drug addiction or drug dependence currently or within the last two years before signing the icf. * have another medical condition, acute or chronic, that in the opinion of the investigator could increase the risk associated with participation in the study or the administration of the investigational product, or that could interfere with the interpretation of the results of the study. * pregnant or lactating. * current use of contact lenses. * have participated in another clinical research study ≤30 days before screening visit. * any use of eye drops, whether otc or rx, in last 14 days. * subjects who have previously used either investigational product in the past. * have known hypersensitivity to the components of the investigational product.
nutrition and pregnancy intervention study

Conditions: Pregnancy; Obesity; Gestational Diabetes Mellitus; Adiposity; Type2 Diabetes; Cardiovascular Risk Factor; Eating Behavior; Liver Diseases; Neurodevelopmental Disorders; Cognitive Developmental Disorders

Summary: a randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. the intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery. the aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. also the underlying metabolic mechanisms will be investigated. follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. the aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.


Eligibility criteria:
inclusion criteria: * pregnant, less than 17 gestational weeks * overweight * healthy exclusion criteria: * diabetes (type 1 or 2) * coeliac disease * increased bleeding tendency

Keywords: nutrition probiotics fish oil
real-world clinical effectiveness and patient insight associated with adding sodium glucose co-transporter 2 inhibitor to gliclazide modified release

Conditions: Type 2 Diabetes

Summary: the study objectives are to assess over the gliclazide mr-sglt2i combined treatment course in patients with t2dm adding sglt2i to gliclazide mr-based therapy. the primary objective is to determine the effectiveness of adding sglt2i to gliclazide mr-based therapy in patients with t2dm, as measured by hba1c changes.


Eligibility criteria:
inclusion criteria: * patient diagnosed with t2dm for at least two years prior to index date * patient aged ≥18 years at the index date * patient naïve to sglt2i prior to index date * patient treated with gliclazide mr at a minimum daily dose of 60 mg at the index date * starting treatment with sglt2i added to gliclazide mr based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide mr-sglt2i treatment * presence of at least two assessments of hba1c laboratory test results from the medical records exclusion criteria: * diagnosis of diabetes other than t2dm (e.g., type 1, gestational) at index date * use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date

Keywords: observational hba1c type 2 diabetes gliclazide mr sglt2i gliclazide mr combined to sglt2i retrospective chart review
evaluation of the role of oct in the detection of hiv-associated neurocognitive disorder

Conditions: AIDS-Related Dementia Complex

Summary: the purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect hiv-associated neurocognitive disorder compared to mri and usual cognitive screening tools.


Eligibility criteria:
inclusion criteria: * hiv infection * antiretroviral treatment * undetectable plasmatic hiv viral load (viral load\<50 copies/ml) for at least 6 months * ability to understand and give approved consent exclusion criteria: * any present or past ophthalmologic illness that may impair oct results * previous cerebral infection with sequel * previous cerebrovascular disease with sequel * severe psychiatric illness * active alcohol or drug abuse * active chronic hepatitis c * inability to perform french cognitive assessment * inability to perform a mri * inability to perform a lumbar puncture

Keywords: optical coherence tomography
asthma self-management for adolescents

Conditions: Asthma

Summary: the goal of this study is to help adolescents with asthma learn to control their illness and live without restrictions. we hypothesize that an intensive school-based asthma education program for students in 9th and 10th grade who have persistent asthma, together with asthma education for their primary care physicians, will improve the students' health status, quality of life, and ability to control their asthma through self-management.

five public high schools from areas in new york city with high asthma rates will be enrolled in the study. in each school, we will identify students with asthma using a brief, self-administered survey that asks questions about current symptoms of wheeze, persistent cough, chest tightness, night waking, and past diagnosis of asthma. eligible students will have the program explained to them individually. caregivers of students who express interest in the program will be contacted to obtain written, informed consent. an equal number of students in each school will be randomly assigned to the immediate intervention group and to a control group that will receive the program 12 months later. students assigned to the immediate intervention group will take part in three group workshops to learn about the chronic nature of asthma, how to control asthma by monitoring symptoms and using medicines consistently, and how to take preventive management steps using environmental control strategies and a written treatment plan from their physician as a guide for adjusting their medicines. they will also receive individual coaching by a health educator to assess how the students are doing and feeling, help them interpret their symptoms and responses to medication, and encourage them to take the next steps to control asthma. before the visit we will have asthma specialist physicians on our staff make a telephone call to the student's physician to alert them that the student will make a visit, that the student will bring symptoms diaries, and to encourage the physician to review the diaries, prescribe according to nhlbi guidelines, and provide a written treatment plan. the intervention for each student will last three months. during the follow up year, no educational contact will be made with control group students, families, or physicians. following completion of the study 12 months later, these students will be offered the same intervention provided to the immediate intervention group.

Eligibility criteria:
inclusion criteria: * 9th or 10th grade high school student * diagnosed moderate to severe persistent asthma * used physician prescribed asthma medicine in past 12 months exclusion criteria: * comorbidity with other diseases that affect lung function * enrollment in special education classes for learning disabilities

Keywords: asthma adolescents patient education schools
special drug use-results surveillance of scemblix tablets

Conditions: Chronic Myeloid Leukemia

Summary: uncontrolled, central registration system, all-case, multicenter, special drug use-results surveillance.

the objective of this study is to collect data on the occurrence, severity, clinical courses of the safety specifications of asciminib, identify factors etc. involved in occurrence and assess its clinical safety inresistant/intolerant chronic myelogenous leukemia patients during an observational period of 48 weeks from the start of treatment with asciminib.

Eligibility criteria:
inclusion criteria: * patients treated with asciminib in japan. exclusion criteria: na

Keywords: chronic myeloid leukemia cml scemblix tablets asciminib resistant or intolerant cml