Kornimate/medical-research-clean huggingface dataset:
comparison of hr011408 and novorapid® in subjects with diabetics

Conditions: Diabetes

Summary: the objective of the study is to compare the pharmacokinetics and pharmacodynamics between hr011408 and novorapid® in subjects with diabetics.


Eligibility criteria:
inclusion criteria: - subjects had to meet all the following criteria to enrol this study 1. male or female aged 18-64 years (both inclusive)； 2. body mass index 18.5-35.0 kg/m2 (both inclusive)； 3. diagnosed with type 1 diabetes or type 2 diabetes≥ 12 months at screening； 4. hba1c ≤9.0% by local laboratory at screening； 5. current treatment with any basal-bolus insulin regimen or continuous subcutaneous insulin infusion(csii) for ≥ 8 weeks. patients with type 2 diabetes can also take metformin but require a stable metformin dose for ≥8 weeks； 6. current total daily insulin treatment \< 1.2 u/kg/day, and total daily bolus insulin treatment ≥ 0.3 u/kg/day and \< 0.7 u/kg/day. exclusion criteria: - subjects who meet any of the following criteria will be excluded from this study. 1. the following laboratory or ancillary abnormalities were present from screening until randomization: 1) poor blood pressure control, defined as systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg. 2. subject has any history or evidence meet the following diseases or conditions: 1. have had severe hypoglycaemia episodes within 6 months before screening as judged by the investigator. 2. have hospitalization due to diabetic ketoacidosis or hyperglycaemic hyperosmolar state within 6 months prior to screening; 3. proliferative retinopathy, maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator. 3. previous and anticipated concomitant treatments: 1. not able or willing to refrain from any use of herbal products and non-routine vitamins within 14 days or within 5 half-lives (whichever is longer), and routine vitamins within 48 hours prior to trial product administration 2. within 1 month or have within 5 half-lives (whichever is longer) participated in any trail (defined participate in trail as having had randomized) of using investigational drug or therapy prior to screening. 4. general information: 1. smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent nicotine per day). 2. previous participation in this study. participation was defined as randomised. 5. any other situation judged by investigator that may endanger the safety of the subjects or influence the evaluation of the results.
randomized controlled trial on uptake of nhs health checks

Conditions: Cardiovascular Diseases

Summary: the national health service (nhs) health check is a significant part of the strategy to tackle premature mortality and promote healthy lifestyles. public health england aspires to an uptake rate of 75% but national uptake is less than 50%. this study aims to assess the impact of two new behaviourally informed nhs health check leaflets on the uptake of nhs health checks, by randomizing patients in lewisham and north east lincolnshire to the different leaflets and comparing patient-level uptake data. the study will test whether a shorter risk-framed leaflet or a shorter benefits-framed leaflet will be more effective than the current national leaflet at encouraging uptake of the nhs health check.


Eligibility criteria:
inclusion criteria: * due to be invited for an nhs health check * aged 40-74 exclusion criteria: * have an existing cardio-vascular disease-related medical condition * have had an nhs health check in the last five years
primary care isbirt to reduce serious teen health risks

Conditions: Substance-related Disorders; Depression; High-risk Sex

Summary: the goal of the project is to develop and test an internet/intranet-based screening, brief intervention, and referral to treatment (isbirt) system for adolescents that targets a broad range of serious health-risks and problem behaviors.

we have previously developed and tested a computerized substance use screening and feedback program for adolescents. we will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop technological extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.

Eligibility criteria:
inclusion criteria: * 12-21 years old * arriving for non-urgent care * provide informed assent/consent exclusion criteria: * less than 6th grade reading level * unavailable for follow-up questionnaires

Keywords: tobacco alcohol marijuana drug use seat-belt weapons depression suicidality sexual risk behaviors
exact localisation of impacted and supernumerary teeth by cone beam computer tomography

Conditions: Impacted Teeth

Summary: the purpose of this investigation is an exact preoperative 3d-localisation of impacted and supernumerary teeth in the maxilla using cone beam computer tomography

an exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like opt or dental films. in contrast to these two-dimensional imaging methods the cone beam computer tomography (cbct) respectively the digital volume tomography (dvt) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3d-reconstruction in multisection views. a preoperative radiological investigation using cbct on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3d-imaging method. therefore a comparison between the findings on the cbct, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.

Eligibility criteria:
inclusion criteria: * supernumerary and impacted teeth in the maxilla (wisdom teeth excluded) * need for surgical removement * uncertain clinical and conventional radiological finding exclusion criteria: * refused approval * cbct not practicable

Keywords: digital volume tomography cone beam ct impacted and supernumerary teeth dental and maxillofacial radiology
randomized control trial of group intervention with former war-affected boys in the democratic republic of congo

Conditions: Post-traumatic Stress Disorder; Depression; Conduct Disorder

Summary: the purpose of this study is to evaluate, in a randomised control trial (rct), the effectiveness of group-based, trauma-focused cognitive behaviour therapy (tf-cbt) in reducing psychological distress in former child soldiers and other war-affected children in the democratic republic of congo (drc).

to the best of the author's knowledge this is the first group-based mental health or psychosocial intervention developed specifically for psychologically distressed former child soldiers. while cbt is the modality with most empirical evidence for treating war-affected young people, this is the first evaluation with child soldiers specifically. former child soldiers and war affected 'street boys' (aged 13-17) in eastern drc, will be screened for symptoms of psychological distress and then randomly assigned to either a treatment group or a waiting-list control. the treatment groups will receive a 15-session manualised, culturally-adapted, tf-cbt intervention. this includes psycho-education, relaxation, affect modulation, cognitive processing and constructing a trauma narrative. after treatment and post-testing, the waiting-list controls then begin their intervention.

Eligibility criteria:
inclusion criteria: * war-affected children and adolescents exclusion criteria: * no traumatic war events experienced * psychosis * inability to speak swahili, french or english
virtual reality and neurostimulation for early stroke rehabilitation

Conditions: Stroke

Summary: stroke is one of the leading causes of disability, leaving millions of individuals each year impaired with lasting motor and sensory impairments. in the subacute phase, which goes from the first week to 3 months post-stroke, the patient has the highest recovery, which could be boosted by proper technologies intended for the rehabilitation of the patients. the impairments that the patients experience are extremely heterogeneous and go from muscle weakness to spasticity of the paretic side of the body. beyond motor deficits, stroke survivors also suffer from sensory impairment (they do not properly feel with the paretic side of their body), impaired body representation (misjudging the size, position, and movement of their affected limb), which can further hinder recovery. traditional rehabilitation primarily targets motor function, often without considering at all the role of sensory feedback and body perception in the recovery process. however, growing evidence suggests that the combination of multiple sensory modalities towards a multifaceted rehabilitation can enhance neuroplasticity and improve rehabilitation outcomes. to address this, the investigators have developed a novel rehabilitation approach that integrates immersive virtual reality (vr) with transcutaneous electrical nerve stimulation (tens). this system allows stroke patients to interact with a virtual environment while receiving synchronized tactile stimulation, reinforcing sensorimotor integration. unlike conventional therapy, which relies on passive or repetitive exercises, this approach engages patients in active, goal-oriented movements, tailored to their individual recovery progress. by focusing on the subacute stroke population, this project aims to leverage the brain's heightened plasticity during early recovery to maximize functional improvements. the vr-based intervention will adapt to each patient's motor abilities, providing real-time feedback to encourage precise movements and enhance sensory processing. through this multisensory experience, the investigators seek to improve not only motor control but also sensory and body representation measures.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ischemic or hemorrhagic stroke * in the subacute phase (from 7 days to 3 months from last stroke onset) * fugl-meyer-upper extremity (fmue) scale for the motor part: fmue ≥ 10 * ability to sit in an upright position * age between 18 and 80 years exclusion criteria: * other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study. * mini-mental state examination (mmse) \< 24 * epilepsy * nausea, headaches or fatigue due to vr-generated environment ("virtual reality motion sickness") * peripheral nerve damage in the affected arm or hand * pacemaker or other electronic implants

Keywords: stroke virtual reality transcutaneous electrical nerve stimulation multisensory integration task oriented movement rehabilitation
efficacy and safety of pneumatic trabeculoplasty

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to evaluate prospectively the pnt safety and efficacy in term of iop reduction in a group of previously or newly diagnosed glaucomatous subjects.

a group of subjects affected by primary open angle glaucoma (poag) underwent 3 pnt treatments to evaluate one-year efficacy in term of iop reduction and one-year safety in term of incidence of adverse events

Eligibility criteria:
inclusion criteria: * subjects affected by primary open angle glaucoma exclusion criteria: * any local or systemic contraindication to timolol topical therapy * chronic iritis and/or uveitis in one or both eyes, * history of inflammatory glaucoma, * hemorrhagic glaucoma, * post-traumatic glaucoma, * phacolytic glaucoma, * acute glaucomatocyclitic attack, * closed angle/narrow angle glaucoma in one or both eyes, * previous corneal transplantation, * proliferative diabetic retinopathy with/without iris neovascularisation, * significative disk cupping (90% of complete disk area), * large and severe perimetric defects (i. e. a central perimetric residual not above 10 central degrees), * dry/wet age related macular degeneration in one or both eyes, * previous glaucoma surgery (laser therapy was not considered) * keratitis * severe dry eye disease, * corneal dystrophies * high myopia (more than 6 dioptres) * peripheral retinal degenerations with risk of retinal detachment
cma-676 in treating patients with acute myeloid leukemia in first relapse

Conditions: Leukemia

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of cma-676 in treating patients with acute myeloid leukemia in first relapse.

objectives: i. assess the efficacy of cma-676 in terms of the number of patients with acute myeloid leukemia attaining a complete remission. ii. assess the safety of cma-676 in this patient population. outline: this is an open label, single arm, multicenter study. patients receive cma-676 iv over 2 hours on day 1. patients may receive 1 additional dose of therapy 15 to 28 days later. patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death. projected accrual: 55 evaluable patients will be accrued. enrollment will then be extended for up to an additional 55 patients.

Eligibility criteria:
disease characteristics: histologically diagnosed cd33 positive acute myeloid leukemia (aml) in first relapse at least 6 months of complete remission no cns leukemia no aml secondary to exposure to chemotherapy or toxins patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc less than 30,000/mm3 at time of cma-676 administration hepatic: bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 2.0 mg/dl cardiovascular: no severe cardiac disease pulmonary: no severe pulmonary disease other: not pregnant or nursing fertile patients must use an effective method of contraception not known to be hiv positive no prior myelodysplastic syndrome no other active malignancy no uncontrolled infections able to obtain bone marrow aspirate prior concurrent therapy: biologic therapy: no prior bone marrow transplantation no prior anti-cd33 antibody therapy chemotherapy: no prior chemotherapy for aml in first relapse except hydroxyurea at least 24 hours since prior hydroxyurea endocrine therapy: not specified radiotherapy: not specified surgery: not specified other: at least 4 weeks since prior investigational agents

Keywords: recurrent adult acute myeloid leukemia
comparing the effectiveness of papain based chemico-mechanical caries removal gel and 38% silver diamine fluoride for treating active caries lesion of primary molars

Conditions: Dental Caries in Children

Summary: this study aims to investigate the efficacy of silver diamine fluoride (sdf) and papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes: 1. arrestment of caries lesion and the emergence of a new one 2. time required for the treatment 3. adverse events 4. children's anxiety

the traditional approach to removing caries with dental burs is the most often used technique in the treatment of dental caries. however, this method is continuously associated with many disadvantages, such as patients finding drilling uncomfortable, the frequent need for local anesthetic, and detrimental heat effects on the pulp. the purpose of this research was to evaluate three minimally invasive therapies via the assessment of: 1. duration of treatment 2. (feeling of pain) and the need for anesthetic 3. incidents with negative outcomes that have been officially documented 4. filling material adhesiveness fellow up the null hypothesis was that there was no difference among silver diamine fluoride, brix3000 papain based chemico-mechanical caries removal product, and ceramic burr in time, anxiety, and pain, reported side effect randomized control clinical trial will be allocated into 3 groups: s group (treatment with sdf), b group (treatment with brix3000 papain based gel), and c group as control (treatment by rotary handpiece smart bur) setting: sample collection: the samples are to be collected at the college of dentistry, al-mustansiriyah university - iraq- baghdad subject the sample size will be 45 children aged 7-8 years with primary molars with occlusal active caries lesions.

Eligibility criteria:
inclusion criteria: * each child should have primary molars with open carious lesions, either on the occlusal surface or proximal one with the absence of a neighboring tooth. * these lesions should affect the dentin but not expose the pulp. * the depth of the cavities should measure between 40-99 using a diagnodent caries detection instrument for standardization exclusion criteria: * children were excluded if parents were unwilling to be assigned to any of the approaches * children that had any abnormal medical condition or silver or papain allergy * chose molars with clinical or radiographic signals of pulp involvement

Keywords: cmcr sdf ceramic bur
hormone therapy with or without docetaxel and estramustine in treating patients with prostate cancer that is locally advanced or at high risk of relapse

Conditions: Prostate Cancer

Summary: rationale: androgens can stimulate the growth of prostate cancer cells. drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. it is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. purpose: randomized phase iii trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.


Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * locally advanced disease or at high risk for relapse * no clinically or radiologically suspected metastases * prior lymphadenectomy required * meets at least 1 of the following criteria for poor prognosis: * gleason score greater than 7 * t3 or t4 disease * prostate-specific antigen greater than 20 ng/ml * n1 disease patient characteristics: age * under 80 performance status * ecog 0-2 life expectancy * more than 10 years hematopoietic * absolute neutrophil count greater than 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * ast and alt no greater than 1.5 times upper limit of normal (uln) * bilirubin no greater than uln renal * creatinine less than 1.6 mg/dl or * creatinine clearance greater than 60 ml/min cardiovascular * no uncontrolled or severe cardiovascular disease * no prior thrombosis pulmonary * no prior pulmonary embolus other * no active infection * no intolerance to aspirin * no other prior malignancy except basal cell skin cancer * no physical or psychological condition that would preclude study compliance prior concurrent therapy: biologic therapy * no concurrent immunotherapy chemotherapy * no prior chemotherapy * no other concurrent chemotherapy endocrine therapy * no prior hormonal therapy * no other concurrent hormonal therapy radiotherapy * not specified surgery * see disease characteristics other * no other concurrent anticancer therapy

Keywords: stage iii prostate cancer stage iib prostate cancer stage iia prostate cancer
conditioning brain responses to improve thigh muscle function after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Injury

Summary: the purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies acl injury can be improved through a form of mental coaching and encouragement, known as operant conditioning.

thigh muscle weakness is a common result after anterior cruciate ligament (acl) injury and reconstruction surgery. therefore, reducing thigh muscle weakness after acl injury and reconstructive surgery is important as the quadriceps muscles act as shock absorbers that protect the knee joint. if significant weakness is present in the quadriceps, the knee is exposed to increased forces and often results in degeneration of the structures in the joint leading to osteoarthritis. thus, it is important to investigate activation and strength rehabilitation methods for the quadriceps muscles. this research study is being done to learn if thigh muscle weakness and the lack of muscle activation that accompanies acl injury can be improved by conditioning brain responses (elicited by non-invasive transcranial magnetic stimulation) using a form of training called as operant conditioning.

Eligibility criteria:
inclusion criteria: * aged 18-45 years * suffered an acute, complete acl rupture * have undergone acl reconstructive surgery * willingness to participate in testing and follow-up as outlined in the protocol exclusion criteria: * have suffered a previous acl injury; * have undergone previous major surgery to either knee; * have a history of recent significant knee injury (other than acl) or lower-extremity fracture; * have a history of uncontrolled diabetes or hypertension; * be pregnant or plan to become pregnant; * have metal implants in the head; * have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers); * have unexplained recurrent headaches; * have a recent history of seizures; * be taking drugs that reduce seizure threshold; * have a history of repeated fainting spells;

Keywords: quadriceps activation deficits acl surgery quadrcieps weakness operant conditioning cortical excitability
dbt in borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: subjects will receive a 6-month course of dbt, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist.


Eligibility criteria:
inclusion criteria: is a male or female between 18 and 60 who meets criteria for borderline personality disorder and has had at least 2 prior instances of suicidal or parasuicidal behavior. either is off psychotropic drugs or is on a stable medication regimen. (during the study, psychotropic medications will be prescribed by a psychiatrist in the mood and personality disorders group.) exclusion criteria: meets criteria for schizophrenia, bipolar disorder, mental retardation or current or recent substance dependence. subjects also should not currently be in individual psychotherapy. (case management and work therapy programs are allowed.)

Keywords: borderline personality disorder bpd dialectical behavior therapy dbt