Kornimate/medical-research-clean huggingface dataset:
alk21-006ext: long-term safety of medisorb® naltrexone (vivitrol®) in alcohol- or opioid-dependent adults (extension of study alk21-006 [nct01218997])

Conditions: Alcoholism; Opiate Dependence

Summary: this was a multicenter extension of alkermes' study alk21-006 (nct01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. all subjects received open-label medisorb® naltrexone 380 mg (vivitrol®). planned treatment duration was up to 3 years. alkermes terminated the study for business purposes in december 2006. the median duration of treatment among all subjects in this extension study was 43 weeks.

from the date of successful completion of study alk21-006 (base study \[nct01218997\])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study. study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of vivitrol therapy. if the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. the naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.

Eligibility criteria:
primary inclusion criteria: * adults with a diagnosis of alcohol and/or opioid dependence as defined by the diagnostic and statistical manual of mental disorders (dsm-iv) who had satisfactorily completed alkermes' study alk21-006 or other qualifying medisorb naltrexone study * willing and able to return for scheduled clinic visits and study assessments * had a stable address * agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential * written informed consent primary exclusion criteria: * pregnancy or lactation * terminated early from study drug in a previous medisorb naltrexone clinical trial * any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
hla and it relation with the development of proliferative diabetic retinopathy in mexican population

Conditions: Diabetes Mellitus Type 2; Proliferative Diabetic Retinopathy

Summary: one of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. the aim of this study is to explore the inmunogenetic profile and the influence of hla in this variations of the sickness to predict the severity of diabetic complications.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy * diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy exclusion criteria: * systemic hipertension * cardic disease * lupus * any kind of artritis * allergies * optic neuritis * vkh * cancer * inmunological diseases

Keywords: diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy diabetes mellitus type 2 with 10 years of diagnosis and proliferative diabetic retinopathy
effect of controlled adverse environment (cae) on tear film stability

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to evaluate the effect of the controlled adverse environment (cae) on mean break-up area in subjects diagnosed with dry eye syndrome.

single-center, pilot, controlled adverse environment (cae) study. this is a single-center, one visit, pilot, cae study. dry eye subjects (n=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before cae exposure and after cae exposure. all subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. subjects who qualify will then undergo cae exposure for 90 minutes. at the end of cae exposure subjects will undergo dry eye assessments again.

Eligibility criteria:
inclusion criteria: * at least 18 years of age \& either sex, any race * willing and able to follow all instructions * positive history of dry eye disease * use or desire to use drops for dry eye within the past 6 months exclusion criteria: * have planned surgery during trial period * female currently pregnant, planning a pregnancy or lactating * use of disallowed medications * have ocular infections, or ocular conditions that could affect study parameters * have used an investigational drug or device within 30 days of start of study * female that is currently pregnant, planning a pregnancy or lactating
effect of probiotic lozenges on halitosis in patients with chronic periodontitis

Conditions: Halitosis

Summary: the purpose of this study is to determine whether lactobacillus reuteri-containing lozenges (prodentis) are effective in treatment of halitosis in patients with chronic periodontitis.

bad breath (oral malodor, lat. halitosis) is amongst most common patients' complaints in the dental office. ironically, available literature and research done on this topic thus far are relatively scarce. oral malodor is most commonly caused by oral bacteria (87%), yet it can also be sourced from ear, nose and throat region and in a small percentage from distant parts of the body or is of unknown origin. periodontal pathogens and other gram(-) anaerobic microorganisms such as porphyromonas gingivalis, treponema denticola, prevotella intermedia, fusobacterium nucleatum, enterobacter cloacae, prevotella loescheii and porphyromonas endodontalis are regarded as producers of malodorous gases. namely, these bacterial species and periodontal pathogens particularly produce so called volatile sulfur compounds (vsc) which give mouth air its malodorness. methylmercaptan, hydrogen sulfide and dimethyl sulfide are waste products of bacterial metabolism, specifically degradation of sulfur-, methionine- and cysteine-containing aminoacids. offensive smells also stem from other compounds which do not contain sulfur, diamines and polyamines such as cadaverine, putrescine and skatole. probiotics are defined as living microorganisms which are considered to have beneficial health effect on their host when consumed in adequate amount. regarding their advantageous role in periodontal disease, inhibition of specific periodontal pathogens and alteration of host immune response through multifactorial causes are thought to be their main working mechanisms. reuterin and reutericyclin are two bacteriocins produced by lactobacillus reuteri that inhibit growth of pathogenic bacteria, while bacterium also exhibits strong capacity of host tissue adherence and subsequent competition with pathogens. based on this data, research on efficacy of probiotic lozenges on halitosis in patients with chronic periodontitis.

Eligibility criteria:
inclusion criteria: * adult patients, above age of 30 * non-smokers or ex-smokers (not smoking in the past year) * moderate to advanced untreated chronic periodontitis * good compliance and following of oral hygiene instructions * halitosis in active phase and patient's subjective complaint * informed consent by the patient exclusion criteria * aggressive periodontitis * antibiotics administered up to 3 months prior to this study * pregnancy and breastfeeding * immunosuppressive therapy * oral neoplasms (including radiation or chemotherapy) * diabetes mellitus * acute oral inflammation or infection * poor, unsatisfactory oral hygiene and lack of compliance * use of dietary supplements containing probiotics within 2 weeks prior to study start

Keywords: halitosis chronic periodontitis probiotic
study on the efficacy of vetiver essential oil aroma on depression/anxiety people

Conditions: Anxiety Depression Disorder

Summary: in this study, subjects with depression/anxiety inhaled the essential oil, which contained sedative, soothing, and relaxing active ingredients to stimulate the olfactory nerve. the essential oil further transmitted to the limbic system that controls emotions in the brain, and then affected the human's mood. the natural aroma can not only awaken the limbic system's memory of aroma but also reflect the subconscious area of the brain, with physiological changes (such as controlling blood pressure, breathing, heartbeat, stress changes, memory, and hormonal coordination.) this study monitors the subject's autonomic nerve parameters before and after aromatherapy to obtain the olfactory cerebral nervous system to convey the message. when the study finishes, we expected to help the subject to relax and soothe the mind.

subjects receive three times 30 mins aromatherapy of limon or vetiver essential oil per time for the month. anthropometric measurements such as blood pressure (systolic blood pressure \[sbp\] and diastolic blood pressure \[dbp\]), autonomic nerve parameters including a. sdnn (standard deviation of all normal to normal intervals index); b. hrv（heart rate variability）; c. lf（0.04-0.15 hz）and hf（0.15-0.4 hz）were measured every week. psqi（pittsburgh sleep quality index）and hads (hospital anxiety and depression scale) were measured initial and ten ends.

Eligibility criteria:
inclusion criteria: 1. depressed/anxious people (diagnosed as a single episode of major depression, recurrence of major depression, mild depression, panic disorder, and anxiety.) those diagnosed with symptoms of depression, and anxiety related to stress adjustment disorder, and willing to cooperate with the study. 2. age 20-65 years old exclusion criteria: 1. an alcoholic 2. uncontrolled diabetes 3. those who have had a stroke in the last year 4. pregnant and lactating women 5. people with liver or heart disease 6. arrhythmia or those with a heart rhythm regulator 7. those whose heart has already been fitted with a cardiac catheter stent 8. those who have used central nervous system stimulants (regardless of the length of time) 9. those who are allergic to essential oils 10. those who have used aromatherapy within a month 11. subjects request to withdraw from the trial 12. the host feels unsuitable to continue the study

Keywords: vetiver oil aromatherapy anxiety depression
distribution of helicobacter pylori after gastrectomy

Conditions: Helicobacter Pylori Infections

Summary: the purpose of this study is to know the distribution of helicobacter pylori in stomach before subtotal gastrectomy and after subtotal gastrectomy.

endoscopy and biopsy will be performed to investigate the distribution of helicobacter pylori before and after subtotal gastrectomy.

Eligibility criteria:
inclusion criteria: 1. patients who are indicated to subtotal gastrectomy due to gastric neoplasm 2. aged between 19 to 75 years 3. informed consent exclusion criteria: 1. previous history of helicobacter pylori eradication 2. previous history of proton pump inhibitor use within 6 months

Keywords: stomach neoplasms helicobacter pylori subtotal gastrectomy
real-life effectiveness of vortioxetine in depression

Conditions: Major Depressive Disorder

Summary: worldwide major depressive disorder (mdd) has significant negative personal, societal and economic consequences. vortioxetine (brintellix®) is a new antidepressant authorized since 2013. despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice. the study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life. this is an observational, multi-national, study in patients with mdd initiating treatment with vortioxetine. information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). this study will be conducted in six countries. in total 2,100 patients are planned for enrolment.


Eligibility criteria:
inclusion criteria: * the patient is ≥18 years * the patient is an outpatient, treated in a gp or psychiatric outpatient practice * the patient has a diagnosis of major depressive episode according to local diagnostic criteria * the patient has been prescribed vortioxetine according to the local summary of product characteristics (smpc) exclusion criteria: * the patient is unable to read and understand the information sheet and informed consent form or the patient reported outcomes (pro) * the patient is concurrently participating in a clinical trial * the patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria * the patient has a diagnosis of bipolar disorder according to local diagnostic criteria * the patient has a substance use disorders other than tobacco use disorder * the patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning * the patient has a mood disorder due to a general medical condition or substances * the patient is pregnant, ≤6 months post-partum or breastfeeding * the patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months * the patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel
evaluation of circulating osteogenic factors in trauma patients

Conditions: Healthy; High Velocity Fracture; Cranial Trauma; Spinal Trauma

Summary: bone fractures in traumatic brain-injured and spinal cord-injured patients often heal faster than in other patients. however, such patients are also occasionally prone to bone formation in soft tissues such as muscle. this process is called heterotopic ossification and tends to occur around joints. patients with heterotopic ossification often suffer from complications such nerve compression, ankylosis, chronic pain, osteoporosis, and infections. loss of movement can also interfere with function and the quality of life of patients already experiencing difficulties associated with their trauma. positioning, transfers, and hygiene become difficult and even impossible, which worsens the loss of autonomy. previous research has suggested that an osteoinductive factor (which has the capacity to induce the formation of bone) may be released into the bloodstream following a head or spinal cord injury. the investigators laboratory has shown that a growth factor called bmp-9, when injected into a damaged mouse muscle, has the ability to cause strong ossification in damaged muscle. the investigators would like to find out whether the levels of bmp-9 and/or its receptor (which is called alk1) increase after traumatic brain and spinal cord injuries that occur at the same time as serious orthopaedic traumas. the main goal of the investigators study is thus to determine whether bmp-9 levels increase in the serum of trauma patients.


Eligibility criteria:
inclusion criteria: * cranial trauma with glasgow =\< 8 * spinal trauma with asia a, b, c * high-velocity fracture of femur, tibia, pelvis exclusion criteria: * brain dead * pathological fractures (cancer, osteoporosis) * blood transfusion received * pregnancy

Keywords: cranial trauma with or without high velocity fracture to inferior limb spinal trauma with or without high velocity fracture to inferior limb high velocity fracture to inferior limb
registry for chronic obstructive pulmonary disease with anxiety and depression in china

Conditions: COPD; Anxiety; Depression

Summary: anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (copd). however, the exact prevalence is not known in china. copd patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. the study aim to investigate the prevalence and long-term outcome of anxiety and depression in copd.


Eligibility criteria:
inclusion criteria: * stable chronic obstructive pulmonary disease (copd) patients exclusion criteria: * patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months * patients with tumor history during past 5 years * patients with copd exacerbations during past 4 weeks * participants in clinical trials * patients in pregnancy or breastfeeding * patients unable to complete questionaire independently * patients older than 80 years old * patients receiving long-term domiciliary oxygen therapy
endocuff-assisted versus cap-assisted versus standard colonoscopy

Conditions: Colorectal Polyps; Colorectal Adenomas

Summary: comparison of endocuff-assisted, cap-assisted and standard colonoscopy for assessment of the adenoma detection rate (adr)

the endocuff is a medical device, approved in 2012 by the american food and drug administration, which was also authorized by the european agency for the evaluation of medicinal products. the aim of the cuff is to optimize the view of the colonic mucosa. there is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. the goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Eligibility criteria:
inclusion criteria: * colonoscopy independent from indication * age ≥ 18 * patient is able to provide informed consent for the procedure exclusion criteria: * inflammatory bowel disease stenosis * pregnant of nursing patient * acute diverticulitis * active inflammatory bowel disease * age ≤ 18 * coagulation disorder (inr\>1.4 , thrombocytes \< 50000/µl)

Keywords: adenoma detection rate polyp detection rate withdrawal time coecal and ileum intubation rate
laparoscopic versus open panp-tme for male mid-low rectal cancer patients

Conditions: Rectum Neoplasms

Summary: tme (total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. however, the damage of pelvic autonomic nerve following with tme principle will lead to high incidence of urinary and sexual function disorder. open panp (pelvic autonomic nerve preservation) tme surgery played a role in decreasing incidence of urinary and sexual function disorder. however, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open panp tme surgery (o-panp-tme). laparoscopy-assisted tme surgery (l-tme) is applied wildly nowadays. in the early stage of work, we performed laparoscopy-assisted panp tme surgery (l-panp-tme) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. the results showed that l-panp-tme significantly decreased incidence of urinary and sexual function disorder. in order to further confirm our early work, we design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between l-panp-tme and o-panp-tme.


Eligibility criteria:
inclusion criteria: * age from over 20 to under 60 years; * primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy; * mid-low rectal cancer (distance from anal edge≤12cm); * ct1-3, n0-3, m0 at preoperative evaluation according to the ajcc cancer staging manual seventh edition; * expected curative resection through both l-panp-tme and o-panp-tme; * performance status of 0 or 1 on ecog (eastern cooperative oncology group) scale; * asa (american society of anesthesiology) score class i, ii, or iii; * written informed consent; * urinary and sexual function normal preoperatively exclusion criteria: * women during pregnancy or breast-feeding; * severe mental disorder; * history of previous pelvic surgery; * enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging; * history of other malignant disease within past five years; * history of unstable angina or myocardial infarction within past six months; * history of cerebrovascular accident within past six months; * history of continuous systematic administration of corticosteroids within one month; * contraindication of heart, brain, lung, etc dysfunction; * requirement of simultaneous surgery for other disease; * emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer; * rectal cancer invades surrounding tissues; * existence of genuine incontinence or severe stress incontinence preoperatively
neoadjuvant nivolumab and relatlimab in merkel cell carcinoma

Conditions: Merkel Cell Carcinoma

Summary: the goal of this clinical trial is to test neoadjuvant dual immunotherapy in merkel cell carcinoma with the aim to improve recurrence-free survival

this is a phase 2, open label, single cohort, single centre, clinical trial of neoadjuvant immunotherapy with dual inhibition of pd-1 and lag-3 immune checkpoint pathways. the hypothesis is that neoadjuvant therapy produces a higher pathological response rate (pcr) and a longer recurrence-free survival in a cohort of treatment-naïve patients with resectable stage i (≥10 mm) to stage iii merkel cell carcinoma compared to neoadjuvant nivolumab monotherapy in checkmate 358 (n=123, nct02488759, historical control).

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * written consent histologically confirmed, resectable merkel cell carcinoma with ajcc (8th ed) clinical stage i (≥ 10 mm), ii, or iii * in-transit metastases are permitted if they are completely resectable * measurable disease according to recist 1.1 criteria * tumour amenable to core biopsy * previous radiotherapy permitted if there is recist-measurable progression of disease since the completion of radiotherapy * ecog 0-1 * adequate organ function on blood pathology * life expectancy \>12 months * female patients to use effective contraception during study treatment and for 5 months after last dose. exclusion criteria: * clinical or radiographic evidence of distant metastases * contraindication to nivolumab and / or relatlimab * prior anti-pd-1, ctla-4, pdl-1 or lag 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory t-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment * active autoimmune disease or requirement for chronic steroid therapy other than hormone replacement therapy * a diagnosis of immunodeficiency or chronic steroid therapy \>10 mg od prednisone or equivalent * additional malignancy active within past 3 years; patients with chronic lymphocytic leukaemia can be included in this study. * uncontrolled cardiovascular disease or history of myocarditis - has had an allogenic tissue/solid organ transplant * active hepatitis b (defined as hepatitis b surface antigen \[hbsag\] reactive) or hepatitis c virus (defined as hcv rna \[qualitative\] is detected) infection. * known hiv * pregnant or breast feeding females * concurrent medical or social conditions that may prevent the patient attending assessments or procedures per schedule