Kornimate/medical-research-clean huggingface dataset:
a phase 2, multicenter, randomized, double-blind, placebo controlled study for the pain of diabetic peripheral neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: primary objective: to evaluate the efficacy of skl11197 for the treatment of diabetic peripheral neuropathy pain (dpn). secondary objective: to evaluate the safety and tolerability of skl11197 in subjects with painful diabetic peripheral neuropathy. primary efficacy endpoint: the primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.

this study is a double-blind, placebo controlled study with three phases; 1. a pre-study medication washout/screening phase upto 3 weeks 2. a 3-week, open label phase 3. a 6-week double-blind phase at the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria. eligible subjects will be randomized in a blinded fashion either to continue with skl11197 at 300 mg tid or to take the same number of placebo capsules.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. diagnosis of type 1 or type 2 diabetes mellitus for at least 1 year 3. at least moderate pain, ≥ 40mm on a 100mm vas at the end of washout phase (in absence of any analgesic); 4. hba1c \< 12 % at screening 5. daily pain attributed to diabetic neuropathy for least 3 months prior to screening on the basis of history and physical examination documenting peripheral neuropathy. 6. pain from diabetic neuropathy should be identifiable by the subject. pain must involve the lower extremities and be bilateral. 7. females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, menopause is defined as 1 year since last menstrual period with associated subjective sensations), or, 8. if capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. females capable of bearing children must have negative serum pregnancy (beta-hcg) test at screening and negative urine pregnancy on day 1. exclusion criteria: 1. pregnant or lactating females 2. subjects with bmi over 40 3. pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication) 4. subjects with known clinically significant decreased blood flow to the extremities 5. subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain 6. peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure; 7. have profound autonomic dysfunction, or brittle diabetes; 8. evidence of amputations (including toes), open ulcers, or charcot joint.

Keywords: diabetic peripheral neuropathy
pilot pharmacokinetic study of new nicotine lozenge formulations

Conditions: Healthy Smokers

Summary: the purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (v0474) in comparison with two reference products. the clinical and biological safety of v0474 and the lozenge acceptability will also be assessed.


Eligibility criteria:
inclusion criteria: * healthy male subject aged 18 to 45 years (inclusive) * current smoker of \< or = 10 cigarettes/day * fagerström score \< or = 5 * absence of any clinically significant abnormal finding at physical, ecg, biological examinations in the investigator's opinion exclusion criteria: * presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator * current or recurrent buccal lesions

Keywords: smoking cessation nicotine tobacco use disorder central nervous system agents
pentoxifylline role against chemotherapy-induced neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: chemotherapy-induced peripheral neuropathy (cipn) is a common and debilitating side effect of neurotoxic cancer treatment. estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. to date, there are no approved medications for the prevention and/or treatment of cipn. the objective of the present study is to investigate the beneficial effects of pentoxifylline (ptx) against cipn in breast cancer patients.


Eligibility criteria:
inclusion criteria: * adult patients\> 18 years old. * female patients breast cancer patients who received paclitaxel-based regimen for 12 weeks. * eastern cooperative oncology group (ecog) performance ≤ 2-adequate bone marrow function. * adequate liver and kidney function. exclusion criteria: * children less than 18 years old. * evidence of physical diseases or major surgery. * patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases. * patients with preexisting clinical neuropathy. * patients with diabetes mellitus. * metastatic breast cancer. * patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics. * patients treated with medications that increase the risk of neuropathy. * hypersensitivity to pentoxifylline or xanthine derivatives. * patients retinal bleeding or active peptic ulcer. * patients at high risk for bleeding or taking medications that increase risk of bleeding.
a study to assess metabolic bone disease of prematurity using an acoustic method

Conditions: Metabolic Bone Disease; Osteopenia; Neonatal Rickets

Summary: the goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (vaa), for evaluation of infant bone health with particular application in assessment of bone health in premature infants who are at risk for bone disease.

with increased survival of very low birth weight and premature infants over recent decades, bone assessment has become especially vital with the recognition of metabolic bone disease (mbd) of prematurity. bone assessment became especially vital during last decades with the growing emphasis on metabolic bone disease of prematurity and low-birth-weight infants. statistics shows that up to 50% of low birth weight and preterm newborns are likely to develop metabolic bone disease. currently, no screening test has been shown to provide both sensitive and specific evidence of developing mbd over the first several weeks of life in the premature infants. therefore, there is a need for a non-invasive tool for evaluation of infant bone health. this study will be conducted on premature infants at risk for mbd at multiple time points during their growth, with full term infants as controls. vibro-acoustic analysis (vaa) measurements will be done on the tibia. vaa measurements for the premature infants will be compared to those of full term infants. performance of vaa in identifying osteopenia and its ability to monitor the response to treatment will be evaluated. the investigators will use an ultrasound system that has been used in the pilot study and employ a transducer with a smaller footprint for pediatric application.

Eligibility criteria:
inclusion criteria: * full term newborns, approximately equal number of male and female newborn, age \<28 days. * preterm infants, approximately equal number of male and female preterm infants with gestational age at birth \<37 weeks or birth weight \<1500 grams. exclusion criteria: * infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past. * infants with major congenital anomalies that may affect bone health or structure. * for full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (\<10th percentile for weight) at birth.

Keywords: bone diseases bone health fracture infancy low birth weight infant mineralization neonatal pediatrics premature ultrasound rickets
a research study comparing different ways of increasing the dose of nnc0519-0130 in participants with overweight or obesity

Conditions: Obesity

Summary: novo nordisk is developing a new study medicine nnc0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. this study will look at the safety and tolerability of nnc0519-0130. the purpose of this study is to investigate if different ways of increasing the dose of nnc0519-0130 in the main and extension phase can lessen the side effects that may occur when people take nnc0519-0130. there will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. this study will last for about 24 weeks.


Eligibility criteria:
inclusion criteria: * female of non-childbearing potential, or male. * age 18-64 years (both inclusive) at the time of signing the informed consent. * body mass index (bmi) between 27.0 and 44.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. * considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol. * glycated haemoglobin (hba1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening. * use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, nsaids (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
full pulpotomy versus root canal treatment for teeth with symptomatic irreversible pulpitis

Conditions: Pulpitis - Irreversible

Summary: background the european society of endodontology (ese) and the american association of endodontists (aae) position statements on the management of deep caries and exposed pulp recommended adoption and promotion of strategies aimed at preserving the pulp, but also acknowledged the need for well-designed and adequately powered randomised control trials to provide the evidence needed to support vital pulp treatment (vpt) and change clinical practice. objectives 1. to undertake a randomised controlled clinical trial comparing full pulpotomy with root canal treatment for mature maxillary and mandibular posterior teeth with signs and symptoms indicative of irreversible pulpitis and normal apical tissues in adults. 2. undertake a cost-effectiveness analysis to examine the potential long-term costs and benefits of pulpotomy. 3. undertake a process evaluation to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.


Eligibility criteria:
inclusion criteria: * patients aged 12 years or older (with a mature permanent tooth demonstrating radiographic evidence of a deep caries/restorations and signs/ symptoms indicative of irp (moderate to severe spontaneous lingering pain). tooth will be responsive to cold and ept sensibility testing, restorable and can be adequately isolated during treatment. one posterior tooth (molar or premolar) only per patient. exclusion criteria: * teeth with active periodontal disease (pocket depth \>5mm); teeth indicated for elective root canal treatment for restorative purposes, teeth with apical periodontitis, patients with complex medical histories that may affect their caries experience and healing ability (immunocompromised, radiotherapy), patients who are unable to consent; history of previous trauma to the tooth, presence of apical radiolucency and patients who are pregnant or breast-feeding. intraoperatively, any evidence of purulence or excessive bleeding that cannot be controlled with a cotton pellet with 2-4% hypochlorite for 10 minutes will be excluded.
sublingual misoprostol in medical treatment of first trimester missed miscarriage

Conditions: Miscarriage

Summary: the aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.

the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. participants will be divided into 2 groups one group (a) will receive sublingual misoprostol 400 mcg and the other group(b) will receive sublingual misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.

Eligibility criteria:
inclusion criteria: * all women above 18 years of age * less than 12 weeks of gestation. * pregnancy is confirmed by pregnancy test or ultrasound scan. * missed abortion * normal general and gynecological examination. exclusion criteria: * hemodynamically unstable. * suspected sepsis with temperature 38 °c. * concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, * respiratory illnesses, recent liver disease, or pruritus of pregnancy. * presence of intrauterine contraceptive device (iucd). * suspect or proven ectopic pregnancy. * failed medical or surgical evacuation before the presentation. * known allergy to misoprostol.

Keywords: miscarriage sublingual misoprostol
correlation of somatic dysfunction with gastrointestinal endoscopic findings

Conditions: Segmental and Somatic Dysfunction; Pathological Conditions, Signs and Symptoms; Ectopic Intestinal Mucosa

Summary: the purpose of this study is to correlate the link between palpatory findings of somatic dysfunction and gastrointestinal endoscopic evidence of changes in mucosa. the investigators' hypothesis is that there is a direct connection between somatic palpatory changes and intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.

the study protocol is limited to an extra physical examination (the focused structural exam) prior to a scheduled routine or diagnostic endoscopy. immediately prior to the scheduled endoscopy, subjects enrolled in the study will be palpated by a neuromuscular medicine (nmm)/osteopathic manipulative medicine (omm) specialist for spinal tenderness, tissue texture changes and asymmetry or restricted range of motion as well as tenderness of chapman points. the entire spine from the occipitoatlantal joint to the sacrum will be evaluated along with specific intercostal abdominal and lower extremity areas. the positive structural examination findings of spinal tenderness, tissue texture changes and asymmetry or restricted range of motion will be compared to the visual and pathological findings recorded in the operative report of the endoscopy procedure and the pathological report of any biopsies obtained during the endoscopic procedure.

Eligibility criteria:
inclusion criteria: * patients already scheduled for upper or lower endoscopy at kirksville family medicine clinic * must be 21 years of age or older * subjects must be able to lie in the prone position for 30 minutes exclusion criteria: * subjects cannot have history of spinal fractures or surgical intervention of the spine that could alter the palpatory findings of the spinal and paraspinal regions * subjects who are wards of the state or are unable to sign the consent form on their own behalf will be excluded * subjects will be excluded if they are unable to lie prone for 30 minutes * subjects will be excluded if they are not already scheduled for an endoscopy

Keywords: osteopathic manipulative medicine (omm) neuromuscular medicine (nmm) somatic dysfunction correlational study endoscopy
novel adaptive cognitive training in autistic adults with co-occurring insomnia

Conditions: Autism Spectrum Disorder; Insomnia

Summary: the proposed study will test the usability and feasibility of a novel cognitive training (cogmuse) for autistic adults with co-occurring insomnia (cogmuse- aut). participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. weekly check-ins will be conducted by study staff over teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. during these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (geneactiv). geneactiv is a watch-like device that monitors light and movement activity.


Eligibility criteria:
inclusion criteria: 1. 18+ years of age 2. diagnosed with asd (see 2a). 3. verbal iq \>= 70 (measured via the weschler abbreviated scale of intelligence 2nd edition28); to ensure verbal skills sufficient to participate in treatment 4. able to undergo actigraphy assessment 5. can read and understand english 6. diagnosed with insomnia (see 3a). 7. no prescribed or otc sleep medications for 1+ month, or stabilized on medications for 6+ weeks. 2a) asdb: a) previous dsm diagnosis of asd (self-reported by asd adult and guardian; confirmed by clinical documentation provided to project coordinator), 2) evaluation using gold-standard diagnostic tools (i.e., autism diagnostic observation schedule (ados) and/or autism diagnostic interview -revised \[adi-r\]). 3a) insomnia: a) insomnia complaints for 6+ months that b) occur despite adequate opportunity and circumstances for sleep, c) consist of 1 or more of the following: difficulty falling asleep, staying asleep, or waking up too early, d) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, f) baseline diaries and actigraphy indicate \>30 minutes of sleep onset latency or wake after sleep onset on 6 or more nights. exclusion criteria: 1. unable to provide informed consent 2. diagnosis of sleep disorder other than insomnia \[i.e., sleep apnea (apnea/hypopnea index, ahi \>15), periodic limb movement disorder (myoclonus arousals per hour \>15)\], 3. comorbid bipolar or seizure disorder (due to risk of sleep restriction treatment) 4. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders) 5. severe untreated psychiatric comorbidity 6. psychotropic or other medications (e.g., beta-blockers) that alter sleep 7. participation in non-pharmacological treatment (including cbt) for pain, sleep or mood outside current trial.
effectiveness and safety of korean medicine treatment for cervical disc herniation

Conditions: Neck Pain; Cervical Radiculopathy; Intervertebral Disc Displacement

Summary: a prospective observational study investigating the effectiveness and safety of integrative korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of jaseng hospital of korean medicine as assessed through of pain, functional disability, work loss and quality of life patient-reported outcomes

this is a prospective observational study to the aim of investigating the effectiveness and safety of integrative korean medicine treatment (generally consisting of herbal medicine, chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in cervical disc herniation patients with neck pain or cervical radiculitis diagnosed by cervical mri and clinical symptoms including cervical radiculopathy at 4 locations of jaseng hospital of korean medicine (gangnam, bucheon, daejeon, haeundae) as assessed through of pain, functional disability, work loss, and quality of life patient-reported outcomes with a 5-year follow-up period

Eligibility criteria:
inclusion criteria: * patients with age between 19 years \~ 65 years * patients with one arm pain or both side arm pain or neck pain with intensity of nrs ≥6 which occurred less then 12 month before * patients with cervical radiculopathy symptoms of one or both side of arms * patients diagnosed with cervical disc herniation with over protrusion degree of prolapsed inter-vertebral disc assessed on mri * patients with plans of receiving korean medicine treatment for cervical disc herniation for ≥2 months * patients who have agreed to study participation exclusion criteria: * patients with other systemic diseases that may interfere with treatment effect or outcome interpretation * patients with soft tissue pathologies or pathologies of non-spinal origin that may cause neck pain or radiating arm pain (e.g. spinal tumor, rheumatoid arthritis) * patients with medical history of cervical myelopathy which can cause neck pain or radiating arm pain * patients with medical history of surgery in relation with cervical disc herniation * patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anticoagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment) * pregnant patients or patients planning pregnancy * patients with serious psychological disorders * patients unable to fill out study participation consent form * patients deemed unsuitable for study participation as assessed by the researchers

Keywords: korean medicine effectiveness neck pain
biomarker-driven phenotypic dissection of amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: the goal of this observational study is to understand the clinical variability in a population of als patients using multidimensional biomarkers. the main questions it aims to answer are: * which set of biomarkers explain genotypic-phenotypic correlations in als? * which set of biomarkers can be used to subdivide the als population in homogeneous subgroups? participants will undergo: * neurological evaluation * neurophysiological evaluation * neuropsychological evaluation * whole exome sequencing * biomarker measurement in csf and plasma


Eligibility criteria:
inclusion criteria: * diagnosis of als or other motor neuron disease * residence near the study centers exclusion criteria: * refusal to participate to the study * unable/unwilling to perform follow-up visits
observational study to observe the safety of novomix® 30 treatment in patients with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during novomix® 30 treatment.


Eligibility criteria:
inclusion criteria: * any patient with diabetes type 2 diabetes * currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin * selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient exclusion criteria: * known or suspected allergy to study product(s) or related products * pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months