Kornimate/medical-research-clean huggingface dataset:
study on clinical effectiveness of l-oxiracetam injection

Conditions: Craniocerebral Injury

Summary: a randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase iii clinical trial of l-oxiracetam injection to improve memory and cognitive impairment in patients with craniocerebral injury.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old (including upper and lower limits), male or female 2. craniocerebral injury meets all of the following conditions: this diagnosis has a clear head trauma, closed head injury, or head injury with cerebrospinal fluid ear leak and / or nasal leak and / or intracranial gas accumulation; mri or ct confirmed intracranial hemorrhage above the cerebellum (including cerebral contusion, subarachnoid hemorrhage, epidural hematoma, subdural hemorrhage, intracranial hematoma, etc.), with or without transient coma; craniocerebral injury is classified as mild or moderate (gcs score 10-15 points); conservative treatment. 3. within 72 hours after head injury, patients with stable and mentally handicapped mental state examination (mmse) scores are lower than normal. 4. the legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form. exclusion criteria: 1. people who are known or suspected to be allergic to the test drug and its ingredients. 2. after the injury, drugs that improve cognitive function such as the prohibited drugs listed in the protocol have been used. 3. with a history of severe traumatic brain injury, a history of cerebrovascular accidents, and structural craniocerebral lesions. 4. with diseases such as speech and hearing impairment that cannot cooperate with the completion of cognitive function assessment. 5. a secondary brain injury occurred after the craniocerebral injury. 6. those who need craniotomy or extraventricular drainage. 7. combining with other serious large organ damage or serious complications may affect the test life. 8. patients with active epilepsy who had seizures within 1 year. 9. patients with severe liver and kidney disease. 10. complicated with severe heart disease, lung disease, blood and hematopoietic diseases, gastrointestinal disease, serious or progressive disease. 11. past or present with a malignant tumor 12. combining neurological and mental disorders that make it impossible or unwilling to cooperate. 13. women who are pregnant, breastfeeding or have a recent birth plan. 14. researchers do not consider it appropriate to participate in the clinical trial. 15. those who have participated in other clinical trials and used test drugs 3 months before the trial.

Keywords: l-oxiracetam cognitive impairment craniocerebral injury
a study of jnj-79032421 targeting mesothelin for advanced stage solid tumors

Conditions: Advanced Stage Solid Tumors

Summary: the purpose of this study is to determine recommended phase 2 dose(s) (rp2ds) of jnj-79032421 and to determine the safety and tolerability of jnj-79032421 at the rp2d(s).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. participants must have progressed after at least 2 prior lines of systemic therapy and have either, i) platinum-refractory disease (ie, persistent disease following completion of platinum-based primary chemotherapy); or ii) platinum-resistant recurrent disease; b) primary pleural or peritoneal mesothelioma. sarcomatoid and well differentiated papillary histologies are not allowed. participants must have progressed after at least 1 prior line of systemic therapy; c) pancreatic ductal adenocarcinoma. other histologies and mixed histologies are not allowed. participants must have progressed after at least 1 prior line of systemic therapy. * measurable or evaluable disease: a) part 1: measurable or evaluable disease; b) part 2: at least one measurable lesion per recist v1.1. participants with mesothelioma must have disease measurable per mrecist v1.1. * can have a prior or concurrent second malignancy (other than the disease under study) whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * eastern cooperative oncology group (ecog) performance status grade of 0 or 1. * selected participants in the pharmacokinetic and pharmacodynamic (pk/pd) cohorts (part 1) as well as selected participants in part 2 must agree to undergo mandatory tumor biopsies. exclusion criteria: * history of known central nervous system (cns) or leptomeningeal involvement. * left ventricular ejection fraction on screening echocardiogram below normal institutional limits. * history of talc pleurodesis for pleural effusion within 3 months of starting study treatment. * concurrent empyema of the lung pleural space requiring antibiotics or chest tube or evidence of resultant fistula formation. * history of hyperthermic intraperitoneal chemotherapy (hipec) within 6 months of starting study treatment.
the effect of elemental diet on gastric emptying

Conditions: Postprocedural Delayed Gastric Emptying

Summary: in patients with percutaneous endoscopic gastrostomy (peg) delayed gastric emptying has been speculated as a cause of aspiration pneumonia. elemental diet may facilitate gastric emptying in peg patients as compared with regular liquid enteral nutrients, resulting in the prevention of aspiration pneumonia.


Eligibility criteria:
inclusion criteria: * percutaneous endoscopic gastrostomy patients exclusion criteria: * history of abdominal surgery
resin infiltration and fluoride varnish lesion arresting efficacy on non-cavitated proximal lesion

Conditions: Dental Caries on Smooth Surface Limited to Enamel; Tooth Demineralization; Dental Caries; Dentistry, Operative; Dental Caries Activity Tests; Cariogram

Summary: protection of dental hard tissues is one of the most important points of cariology. for this purpose, oral hygiene training (effective brushing and motivation), non-invasive approaches such as flouride varnish applications and micro-invasive approaches such as resin infiltration technique are applied in clinical practice. in this study, the effect of resin infiltration or fluoride varnish application on lesion depth in individuals with moderate/high caries risk was investigated. the study was a randomized controlled, prospective and parallel designed clinical trial. 60 patients were included in the study and patients were randomly allocate to the groups. caries risk of individuals was determined according to cariogram, which is a computer program․ according to visual clinical examination, stage the caries continuum were (icdas 1,2) scored and the caries diagnostic criteria scored acording to (nyvad 1, 2, 4, 5) the teeth wich has one caries lesion in border of enamel or prolonged to first 1/3 part of dentin in bite-wing radiograph (lesion level: e1, e2, d1) included in this study. patient's gingival condition evaluating at initial and control sessions with gingival index (0=healthy, 1=mild inflammation, 2=moderate inflammation and bleeding on pressure). oral hygiene training was given to all subjects included in the study and the use of fluoride toothpaste (1450 ppm, naf) was recommended. this study was performed in a single center by experienced physicians. resin infiltration (icon dmg, usa) was applied to one of the groups(n=30), while fluoride varnish (clinprotm white varnish 22600 ppm, 3m espe, usa) was applied to the other group(n=30). the patients follow-up time was anticipated for 60 months in 6-month periods. the inicial visual clinical examination(t0) and follow-up sessions (t 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) were conducted by two experienced researchers blind to the group information. at the aim of the study, evaluation difference in non-cavited proximal lesion progression between the resin infiltration (micro-invasive) and fluoride varnish (non-invasive) treatment options at the individuals with moderate or high risk of caries.


Eligibility criteria:
inclusion criteria: * individuals with moderate/high risk of caries * the presence of one or more noncavitated interproximal caries lesions with radiolucencies involving the outher half of enamel up to the outer third of dentin in bite-wing radiographies (lesion depth: e1, e2, d1) * vital posterior teeth without cavitation in which the clinically active non-carious lesion had * only one tooth per patient was included in the study exclusion criteria: * incapable of contracting * pregnancy * presence of secondary caries or restoration in the involved tooth * lack of contact teeth * incapable of contracting

Keywords: tooth demineralization dental caries dentistry, operative dental caries activity tests
effects of antioxidants and b vitamins supplements on inflammation in obese diabetic patients

Conditions: Diabetes; Obesity

Summary: substantial evidence shows that diets incorporating antioxidants and b-group vitamins can offer significant protection against infections and cardiovascular disease (cvd) especially in diabetic patients. the proposed study will determine whether improvements in antioxidants and b-group vitamins in diabetic patients who are known to have a high risk of cvd will lead to a clinical benefit

following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily b-group vitamins (5 mg folic acid, 5mg vitamin b-2, 50 mg vitamin b-6, 0.4 mg vitamin b-12) and antioxidant vitamins \[800 iu (727mg) of a-tocopherol and 500mg of vitamin c\] \[n=48\], or no supplements \[n= 48\] daily for 90 days. all subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. the assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. a fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis. potential significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * severe chronic clinical or psychiatric disease, * participating in other intervention trials, * on dietary supplements and * those unable to give an informed written consent

Keywords: antioxidant vitamins diet
utility of a supraaponeurotic mesh as prophylaxis of the midline eventration after an oncological colorrectal resection

Conditions: Eventration

Summary: randomized prospective experimental study, in which the effect of a prophylactic mesh is assessed in the eventration rate diagnosed by ct at one year after surgery in patients with crc who underwent elective intervention for supra-infraumbilical midline laparotomy, considering as treatment the supra-aponeurotic mesh positioning (experimental group), and comparing it to the standard closing with a continuous suture using slow absorption monofilament.

randomized prospective experimental study, in which we evaluate patients with crc who underwent elective intervention for supra-infraumbilical midline laparotomy in order to: main objective: - to assess the effect of the prophylactic mesh in the eventration rate diagnosed by ct at one year after surgery in patients with crc who underwent elective intervention for supra-infraumbilical midline laparotomy. secondary objectives: * to compare the appearance of complications in the control group and in the experimental group. * compare costs derived from short and long-term mesh placement in both groups. we consider as treatment the supra-aponeurotic mesh positioning (experimental group), and compare it to the standard closing with slow absorption monofilament.

Eligibility criteria:
inclusion criteria: * elective surgery for colorectal cancer. * surgery by middle laparotomy. * informed consent signed by the patient. * age \> 18 years. exclusion criteria: * midline hernia or eventration. * presence of mesh in the abdominal wall because of a previous surgery. * palliative surgery. * synchronous metastases (stage iv cancer according to tnm).
biomarkers of isolated coronary arteritis and related pathogenic mechanism

Conditions: Coronary Artery Disease; Arteritis

Summary: the design of this study is generally divided into two parts: first, establish an isolated coronary arteritis cohort. then, through the case-control study, the clinical characteristics of patients with isolated coronary arteritis and patients with coronary artery disease are compared and the preliminary screening criteria for patients are constructed. then, through mass spectrometry flow cytometry and cytokine detection, the biomarkers related to immune inflammation related to the occurrence of coronary artery disease are discussed to provide clues for further exploring the pathogenesis; subsequently, a prospective cohort study was conducted to compare the clinical characteristics and biomarkers of patients with or without adverse cardiovascular events by following up patients with coronary inflammation, and to explore the prognostic factors of patients with coronary inflammation.


Eligibility criteria:
inclusion criteria: isolated coronary arteritis group inclusion criteria 1. age ≥ 18 and ≤ 75; 2. patients with coronary heart disease, complete revascularization, standardized medication, and repeated hospitalization for myocardial infarction or ischemia within 1 year. 3. coronary angiography showed coronary artery stenosis or occlusion. 4. the patient (or legal guardian) is fully informed of the test process and signs the informed consent form. coronary artery disease group inclusion criteria 1. age ≥ 18 and ≤ 75; 2. patients with coronary heart disease (at least one vessel underwent coronary stent implantation) and regular medication. 3. no hospitalization with myocardial infarction or ischemia drive occurred within 1 year. 4. the patient (or legal guardian) is fully informed of the test process and signs the informed consent form. exclusion criteria: 1. the patient has the following conditions: 1. have other serious diseases (malignant tumor, heart failure, etc.), and the life expectancy is less than 12 months; 2. the patient has known rheumatic immune diseases such as systemic lupus erythematosus, takayasu arteritis, behcet's disease, nodular polyarteritis, wegener granuloma, eosinophil arteritis, giant cell arteritis, rheumatoid arthritis and immunoglobulin g4 related diseases; 3. variant angina pectoris; 4. coronary artery dissection; 5. thrombophilia; 6. incomplete expansion of stent; 2. mental illness; 3. failure to complete the expected study follow-up for any known reason; 4. the investigator judged that it was not suitable for the enrolled patients.

Keywords: coronary arteritis biomarker inflammation
french memory support system: a pilot study

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to develop a linguistically and culturally appropriate adaptation of the memory support system (mss), an evidence-based intervention to train persons with mild cognitive impairment (mci) to complete personal goals and instrumental activities of daily living independently. the study will involve development of the associated manual, training and patient forms, and outcome measures, and pilot testing of the intervention in a group of french-speaking individuals with mci and their care partners

at enrollment, participants with mci and their care partners will complete french measures evaluating cognitive and functional status. participants and partners will also complete french measures of treatment adherence, instrumental activities of daily living, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. participants will complete the mss training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment.

Eligibility criteria:
inclusion criteria: * diagnosis of single or multi-domain mci * clinical dementia rating global (cdr) score of ≤ 0.5 * dementia rating scale-second edition score of ≥ 115 * available contact with a care partner ≥ 2 times weekly * absence or stable intake of nootropic(s) for ≥ 3 months exclusion criteria: * visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with mss training * concurrent participation in another related clinical trial

Keywords: cognition french
home usability of a nasal lavage system in children

Conditions: Nasal Congestion; Respiratory Tract Infection; Sinusitis; Allergic Rhinitis

Summary: this study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. the device is currently cleared for professional use and home use with a prescription. this is a usability study to demonstrate that this device is appropriate for home use.

nasal congestion is an important complication of viral upper respiratory infections in young children. it can lead to poor eating, sleeping and breathing. recently, the fda recommended against using over-the-counter cold remedies in young children because of inefficacy and occasional dangerous side effects. a commonly recommended non-drug solution for nasal congestion is nasal suctioning. this can be effective but currently available methods have been found to be awkward, uncomfortable and ineffective. the studied device has potential for making nasal suctioning easy to perform in the home setting, especially in young children. it is already fda cleared for professional use and this study was developed to demonstrate that it is appropriate for the home as well. this would be significant as it would allow parents a strategy of clearing their child's nose without drugs. the device is automatic and handheld that can irrigate and/or aspirate the nasal cavity with hospital-grade suction. the handle houses a pump that can achieve air flows known to be effective for infant nasal suctioning in the hospital. a disposable wash-head is placed on top. it has an irrigation chamber with 0.9% saline and another chamber for collecting the aspirated nasal contents. the unit operates from a single bi-functional button. several key safety features have been built in such as: a tip that is shaped to maximize the seal but prevent intrusion into the nose; an irrigation function that delivers an optimal volume but prevents flooding the nasal cavity; and a pump that can deliver suction known to be effective in the hospital but whose safety valve does not allow it to rise above dangerous levels. participants were parents of children who have nasal congestion for whom nasal suctioning is traditionally recommended. they were asked to review the instruction manual of the device, and then use it on their children. the primary outcome was proper use of device that was precisely defined. additionally, subjective efficacy of mucus removal, evidence of adverse events and understanding of the device's user manual were also measured.

Eligibility criteria:
inclusion criteria: * parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed. exclusion criteria: * parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning. * additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.

Keywords: nasal suction nasal aspiration nasal saline irrigation nasal lavage
subcutaneous immunoglobulin (hizentra) in patients with dermatomyositis: a proof of concept study

Conditions: Dermatomyositis

Summary: the purpose of the study is to evaluate the effectiveness and safety of human immunoglobulin scig in the form of hizentra (immune globulin subcutaneous) in patients with dermatomyositis. hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body) in patients with primary immunodeficiency. at present, patients with steroid resistant dermatomyositis can only be treated with ivig (the healthy antibodies in ivig can block the damaging antibodies that attack muscle and skin in dermatomyositis) treatment. an evaluation can then be made to see if scig is a suitable replacement and exerts immunomodulatory effect on complement antibodies.


Eligibility criteria:
inclusion criteria: 1. men or woman aged \>18 years 2. diagnosis of dm based on standard criteria 3. receiving the equivalent of at least 0.4 g/kg ivig every 4 weeks (ivig group only) 4. established response to ivig or dependence on ivig to maintain status established either by symptomatic worsening of condition at the end of the inter-dose interval for both groups or by worsening after reduction of the dose within the previous 12 months (ivig group only) 5. ivig regimen stable for 12 weeks while on ivig (minor changes are permitted provided that the dose change is 15% or less) (ivig group only) 6. stable dosing with steroids and/or other immunosuppressives for 12 weeks with no changes schedule or intended. exclusion criteria: 1. pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception 2. severe concurrent medical conditions which would prevent treatment or assessment, including significant hematological, renal or liver dysfunction or malignancies 3. initiation or immunomodulatory treatment other than ivig in the past 24 weeks or modification of immunomodulatory treatment other than ivig in the past 12 weeks. 4. participation in trial of an investigational medicinal product in the past 12 weeks 5. presence of skin infection unrelated to dermatomyositis, severe skin involvement presence of any other medical condition, which in the opinion of the investigator might interfere with performance or interpretation of this study.
phase 2 clinical study in psoriasis with oral investigational drug vx-765

Conditions: Psoriasis

Summary: to evaluate the safety and tolerability of vx-765 in subjects with chronic plaque psoriasis treated for 28 days.


Eligibility criteria:
inclusion criteria: * diagnosed with chronic plaque psoriasis for at least 6 months * prior systemic therapy exclusion criteria: * current or prior history of illness precluding use of immunomodulatory therapy.
evaluation of the effect of live probiotic cultures present in fermented dairy product (yogurt) versus the effect of freeze-dried probiotic sachets on gingival bleeding of adolescents

Conditions: Gingival Inflammation

Summary: to evaluate the effect of probiotics supplied in two different forms (dairy products containing probiotics as yogurt and freeze-dried synthetic probiotics sachets) on improving gingival condition and caries potentiality of dental plaque in adolescents


Eligibility criteria:
inclusion criteria: 1. children aged 12-15 years old 2. children complaining from gingival problems 3. medically free children 4. children not registered in other clinical researches exclusion criteria: 1. children with systemic diseases, mental disorders, chronic debilitating diseases. 2. children using antibiotic treatment during the study 3. children with orthodontic treatment 4. children using antimicrobial mouthwash 5. children taking any probiotic supplemental therapy