Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of liraglutide in combination with an oad in subjects with type 2 diabetes insufficiently controlled on oad alone

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial was conducted in japan. the aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (oad) in japanese subjects with type 2 diabetes who are insufficiently controlled on oad monotherapy. all subjects will continue their pre-trial oad (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.) * japanese subjects with type 2 diabetes on monotherapy with an oad (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved japanese labelling in addition to diet and exercise therapy. total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to visit 1 * type 2 diabetes mellitus (clinically diagnosed) for at least 6 months * hba1c between 7.0-10.0% (both inclusive) * body mass index (bmi) below 40.0 kg/m\^2 * outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. however, hospitalisation for training of self-injection from visit 2 that is for no longer than one week is allowed * subjects able and willing to perform self-monitoring of plasma glucose (smpg) exclusion criteria: * subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer) * calcitonin above or equal to 160 pg/ml * personal history of non-familial medullary thyroid carcinoma * family or personal history of multiple endocrine neoplasia type 2 (men-2) or familial medullary thyroid carcinoma (fmtc) * history of chronic pancreatitis or idiopathic acute pancreatitis * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * treatment with glp-1 receptor agonist or dipeptidyl peptidase 4 (dpp-4) inhibitor within 12 weeks prior to visit 1 * having contraindications to liraglutide and any of the oads (according to japanese labelling)
abequolixron (rgx-104) and durvalumab in lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: non-small cell lung cancer (nsclc) is one of the deadliest types of cancer. in lung cancer patients with a tumor that can be removed by surgery, adjuvant chemotherapy increases survival. neoadjuvant therapy may have advantages such as, it may be more tolerable prior to surgery, earlier treatment may be more efficacious, and it can provide an indication of treatment response. neoadjuvant treatment can provide pre- and post-treatment specimens for correlative analysis to better understand mechanisms of action and resistance. this pilot study will investigate the effects of neoadjuvant durvalumab plus platinum doublet chemotherapy and neoadjuvant durvalumab plus platinum doublet chemotherapy in combination with abequolixron (rgx-104), an lxr/apoe agonist, in subjects with nsclc who are scheduled to undergo surgical resection as part of their standard of care. the purpose of this study is to study how well using a combination of durvalumab, platinum doublet chemotherapy (carboplatin/abraxane or carboplatin/pemetrexed), and abequolixron treats non-small cell lung cancer before surgery. durvalumab (a type of immunotherapy) and platinum doublet chemotherapy are drugs that are individually approved for use during the treatment of cancer. fda (food and drug administration) has not approved the combined use of these drugs in treating non-small cell lung cancer. abequolixron is not fda approved for the treatment of cancer.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent obtained to participate in the study and hipaa authorization for the release of personal health information. 2. age ≥ 18 years at the time of consent. 3. histologically or cytologically confirmed non-small cell lung cancer for which surgical resection would be standard of care. 4. ecog performance status of 0-1 5. body weight of \> 40 kg 6. is able to swallow and retain oral medication. exclusion criteria: 1. participation in another clinical study with an investigational product during the last 3 weeks 2. concurrent enrollment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 3. any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment with the exception of those mentioned in this protocol. concurrent use of hormonal therapy for noncancer- related conditions (e.g., hormone replacement therapy) is acceptable. 4. lack of full recovery from a major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of ip. 5. history of allogenic organ transplantation.

Keywords: neoadjuvant therapy abequolixron (rgx-104) lxr/apoe carboplatin abraxane pemetrexed
regular insulin vs rapid insulin delivered by v-go

Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus

Summary: the purpose of the study is to collect data about how well u-100 regular human insulin can be used in the v-go insulin delivery device compared to u-100 rapid acting insulin in the v-go insulin delivery device. the data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using u-100 rapid acting insulin to u-100 regular human insulin within their v-go insulin delivery device.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 years at time of study enrollment 2. diagnosed with t2d for at least 6 months prior to screening 3. screening visit a1c ≥ 7.0% and ≤ 12.5% 4. prescribed a stable (less than 20% change in the past 30 days) of rapid acting u-100 insulin delivered via v-go insulin delivery device 5. ability to read and understand english 6. willing to complete all study related activities 7. willing and able to understand and sign a written icf indicating that they agree to participate and have been informed of all pertinent aspects of the study 8. must be willing to take and record 7 glucose measurements per time period (pre-morning meal (fasting), pre-midday meal, pre-evening meal, and 2-hours after the start of the morning, midday, and evening meals, and at bedtime) three times throughout the study (prior to visit 2, 3, and 4). 9. completed a 7-point glucose profile prior to visit 2 10. able (by insurance or financial means) to cover the initial investment and ongoing cost of the v-go insulin delivery device, insulin (current rapid acting insulin or potential new regular human insulin), personal glucometer and supplies for the length of the study. exclusion criteria: 1. subject with confirmed type 1 diabetes 2. more than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry 3. history of hypoglycemia unawareness 4. require supplemental insulin in addition to v-go therapy 5. woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. women of childbearing potential are defined as any female who has experienced menarche and who it not permanently sterile of postmenopausal. postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause. 6. woman who are lactating. 7. use of any oral, injectable, or iv steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or iv steroids during the course of the study 8. a recipient of a solid organ transplant 9. current use of u-100 rhi in v-go within 90 days of screening 10. current use of u-500 rhi in v-go within 90 days of screening 11. currently on dialysis 12. medical or other problems which in the opinion of the investigator will render study participation unsafe.

Keywords: vgo insulin type 2 diabetes
safe drinking water for households with infants born to hiv-positive mothers pilot study

Conditions: Diarrhea; HIV Infection

Summary: the purpose of this study is to assess whether children under 2 years and other members of households in which hiv-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.

contaminated drinking water is a leading cause of morbidity and mortality in low-income settings. safe drinking water is of particular concern for hiv-positive mothers since many hiv-infected zambian women choose replacement feeding and early cessation of breastfeeding of infants to minimize the risk of transmission of the virus. this study builds upon preliminary baseline research which determined that hiv-positive mothers would potentially benefit from an intervention that encourages hiv-positive mothers to treat their water at the household level.

Eligibility criteria:
inclusion criteria: * known hiv-status based on clinical testing * have a child between 6-12 months at the initiation of the study * within the catchment area of kasisi or ngwerere health clinics, chongwe district, lusaka exclusion criteria: * lived in the catchment area less than one year or planning to move

Keywords: diarrhea water household water treatment hiv infant health
effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger function in stroke patients with hemiplegia

Conditions: Stroke

Summary: over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. in routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. technology-supported training holds opportunities for increasing training intensity. however, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. the force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. the aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.


Eligibility criteria:
inclusion criteria: * first-ever stroke * aged 20\~80 years old * post-stroke time≤6 months * clinically diagnosed with a central paresis of the right arm/hand (brunnstrom stage of the affected upper limb≥ii, brunnstrom stage of the affected hand ii\~v, active flexion range of motion of the affected finger joint≥10°, mas of affected upper limb and finger≤1+ * sitting balance≥level 2 * no serious depression and no visual impairment * cognitive and speech abilities sufficient to understand instructions and to provide informed consent exclusion criteria: * severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance * sensory disturbance of fingers * severe joint pain caused by various reasons affects the functional activities of fingers * complicated with serious heart, lung, liver, kidney or infection * attending another study or therapy to improve arm-hand function

Keywords: hand dysfunction force feedback hand rehabilitation robot task-oriented training neurorehabilitation
effects of single thoracic manipulation and special massage technique (rt technique) on chronic mechanical neck pain

Conditions: Neck Pain

Summary: this study aims to compare the immediate effects of using a single thoracic manipulation combined with special massage technique (rt technique) and single thoracic manipulation alone on pain level at rest, cervical range of motion, upper limb neurodynamic test, neck disability, and adverse effects in chronic mechanical neck pain patients.

- the subjects will be recruited through posted advertisements, and announcements, to find the patients who meet the criteria of mechanical neck pain that is the pain provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature. the subjects will be screened by screening questionnaire, and then will be examined by a physiotherapist. all subjects will be required to sign an inform consent before participating to the study - the sample size was calculated by using the averaged of pain level at rest after treatment from the single thoracic manipulation combined with special massage group and single thoracic manipulation group, after the preliminary procedure that will be conducted with ten subjects per each group. after that, the variance was calculated by using the equation σ2 = (n1-1)s12 + (n2-1)s22/(n1+n2)-2 and the result will be used for calculate the sample size. a drop out rate will be set as 20%. the effect size (∆), the significant level of lower than 0.05 (zα(0.05) = 1.96) and a power of test at 90 percent (zβ(0.2)=1.28) was used to calculate in the equation as follow: n/group = "2(zα + zβ)2σ2" /"∆2"

Eligibility criteria:
inclusion criteria: * they have neck pain on posterior neck or shoulder, which is the area from superior nuchal line to spinous process of 1st thoracic vertebrae, with mechanical characteristics consisting of the symptoms provoked by sustained prolonged neck posture, neck movement or palpation of cervical musculature (martı´nez-segura et al., 2006). * they have symptoms for at least 3 months in duration. * they have pain level at rest at least mild level (from 3 score or greater) measured by visual analog scale (jensen et al., 2003). * they have a baseline neck disability index (ndi) thai version score of 10% or greater (suvarnnato et al., 2013). exclusion criteria: the subjects will be excluded from current study if they have the following conditions including: 1. cervical radiculopathy or myelopathy 2. history of whiplash injury within 6 weeks of examination 3. history of cervical surgery or thoracic surgery 4. history of cervical or thoracic injuries including fracture or dislocation 5. fibromyalgia syndrome 6. the serious spinal conditions including spinal osteoporosis, spinal tuberculosis, and tumors 7. history of treated by spinal manipulation within 2 months before participating in the study 8. the diseases that are contra-indication to receive a spinal manipulation, such as hypertension, heart disease and meningitis 9. pregnancy

Keywords: neck pain, thoracic manipulation, special massage
recombinant zoster vaccine in stable sle patients

Conditions: Herpes Zoster; Recombinant Zoster Vaccine; Systemic Lupus Erythematosus

Summary: the risk of herpers zoster reactivation is higher in sle patients than general population. it has shown that mild or even inactive patients could also have varicella zoster virus (vzv) infections, and they account for about two-thirds of the events. and our previous study indicated that recent various vzv infection was associated with increased risk of disease flares. the risk of virus reactivation limited the use of live-attenuated shingles vaccine in sle patients, especially in whom with high dose of prednisone or immunosuppressants. whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

systemic lupus erythematosus (sle) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). patients with active sle are more susceptible because they require stronger immunosuppressive therapy. however, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. in addition, herpes zoster may trigger lupus flare. a case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent vzv infection was associated with increased risk of disease flares. the risk of virus reactivation limited the use of live-attenuated shingles vaccine in sle patients, especially in whom with high dose of prednisone or immunosuppressants. whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Eligibility criteria:
inclusion criteria: 1. age ≥ 50 years old 2. the disease status is stable (score≤ 6 at screening on selena-sledai); no british isles lupus assessment group (bilag) a and no more than one bilag b; 3. a stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab); 4. sign the informed consent. exclusion criteria: 1. alanine aminotransferase (alt)/aspartate aminotransferase (ast) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min; 2. exposure to cyclophosphamide within the past half year. 3. exposure to rituximab within the past one year. 4. history of herpes zoster within the past three months; 5. pregnancy or lactation; 6. history of malignancy.
validity of sofa score as predictor of mortality in critically-ill burn patients

Conditions: Mortality Prediction

Summary: sofa score is valid for mortality predictor for critically-ill patient in high care and intensive care burn unit


Eligibility criteria:
inclusion criteria: * adult patients (age 18 and above) who admitted to burn unit during sampling period exclusion criteria: * patients discharged or deceased less than 24 hours of admission * patients referred to other hospital within 30 days admission

Keywords: burn injury mortality prediction sofa score organ failure
evaluation of a parent/child cognitive-behaviorial therapy program in adhd children with emotional dysregulation profile

Conditions: Attention Deficit Disorder With Hyperactivity; Attention-Deficit-Disordered Children

Summary: attention deficit disorder (add) with or without hyperactivity/impulsivity (adhd) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. adhd is recognized as the most common psychiatry disorder in children and it's considered as a public health problem. adhd is frequently associated with a new diagnostic entity " disruptive disorder with emotional dysregulation ". this disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age. few studies have examined the elements of emotional dysregulation in adhd in children. many studies have shown the interest of cbt in multimodal management of adhd symptoms and associated disorders. the main objective is to evaluate the effectiveness of a cognitive-behavioral therapy parent/child program versus a body mediation focused on emotional and behaviorial aspects in add children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. secondary objectives are to evaluate the impact of this program, at short-term (at the end of cbt) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress. it's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.

68 patients (parents and children) will be recruited within montpellier university hospital. they will be divided into a cbt group and a control group (body mediation). the cbt group benefits from an intervention based on the program "better manage its anger and its frustrations" of 15 sessions for the children. the control group participates in an intervention of body mediation (theatre) of 15 session for the children. the parents of cbt and control groups participate in an cbt intervention of 8 sessions every 15 days.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 7-13 years ; * children with a diagnostic of adhd (diagnostics criteria from dsm-v); * score cbcl-dp ≥ 180 (" aggressive behavior ", " anxious-depression " and " attention problems ") ; * children follow-up in montpellier university hospital ; * parents and children benefit of social security. exclusion criteria: * children with a developmental delay or severe language disorder ; * families non-french speaking ; * absence of consent signed by parents and child ; * children not living with at least one parent.
vertical climbing (clmbr) exercise for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: this is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (clmbr) or a recumbent cycling ergometer. this feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * confirmed chronic (\>12 weeks) low back pain at screening assessment (based on patient history) * ability to comply with the current mount sinai health system covid-19 requirements for research participants (e.g., vaccination, masks) exclusion criteria: * criteria will be evaluated during the clinical evaluation at the screening visit. all determinations will be the decision of the study physician: * less than 2/10 low back pain on 0-10 numeric rating scale for average pain over past 7 days at baseline assessment * any cardiovascular or musculoskeletal contraindication to exercise * impaired balance contraindicating exercise * known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments * current pregnancy * current medications or new medications commenced that may impact the ability for change to be detected in study * any other contraindication in the opinion of the study physician

Keywords: low back pain exercise vertical climbing
study of isis 301012 (mipomersen) in heterozygous familial hypercholesterolemia subjects on lipid lowering therapy

Conditions: Hypercholesterolemia, Familial

Summary: the aim of this study is to assess the safety and efficacy of varying doses of isis 301012 (mipomersen) as add-on therapy in subjects with heterozygous familial hypercholesterolemia


Eligibility criteria:
inclusion criteria: * weight ≥ 50 kg * diagnosis of heterozygous familial hypercholesterolemia. * females must be non-pregnant and non-lactating. * on stable lipid lowering therapy for at least 4 weeks. * lipid levels meet the pre-specified criteria. exclusion criteria: * subject had heart problems in the prior 6 months. * subject has elevated alt, ast, or cpk. * history of renal disease, liver disease, or malignancy. * use of oral anticoagulants, unless the dose has been stable for 4 weeks * have any other conditions, which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

Keywords: ldl-cholesterol apob-100 heterozygous familial hypercholesterolemia