Kornimate/medical-research-clean huggingface dataset:
dry eye study with cosopt® over 8 weeks in patients with open-angle glaucoma or ocular hypertension (0507a-152)(completed)

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: to evaluate if preservative free cosopt is well tolerated in patients with open angle glaucoma (oag) or ocular hypertension (oh) with dry eyes.


Eligibility criteria:
inclusion criteria: * adult patient with newly diagnosed and untreated for open-angle glaucoma or ocular hypertension with an intra-ocular pressure (iop) of \> 27 mm hg (in at least one eye) and a baseline gss symp-6 total score of 75 or less * patient is male or a female who is highly unlikely to conceive * patient has been recently diagnosed and is presently untreated for open-angle glaucoma or ocular hypertension with an iop of at least 27 mm hg in at least one eye (patient's worse eye) * patient already diagnosed with open-angle glaucoma or ocular hypertension and untreated for at least 30 days are eligible for the study if they have an iop of 27 mm hg or more in at least one eye exclusion criteria: * a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk by administering preservative free dorzolamide-timolol (preservative-free cosopt®) * the presence of any fundus pathology likely to change during the study or to influence iop (background of diabetic retinopathy is permitted) * any contraindication to the use of preservative-free cosopt® including: * bronchospasm, including bronchial asthma or a history of bronchial asthma or chronic obstructive pulmonary disease, sinus bradycardia, second or third degree av block, cardiac failure (grade iii and iv), cardiogenic shock, severe renal impairment (serum creatinine \> 150 umol/l or creatinine clearance \< 30 ml/min) * patient on: * carbonic anhydrase inhibitor, concomitant systemic or dermatological medication known to affect the iop, e.g. clonidine, corticosteroids, oral beta-blocking agents. patient on a non-glaucoma medication that contains a preservative agent, i.e. benzalkonium chloride, benzododecinium bromide or stabilized oxychloro complex * patient with hypersensitivity to any component of preservative free dorzolamide-timolol (preservative-free cosopt®)
benefits of relaxation by music therapy on ptsd symptoms

Conditions: Stress Disorder, Post Traumatic

Summary: ptsd is a debilitating mental disorder that may develop after experiencing or witnessing a life-threatening event. with appropriate care, treatment efficiency is variable and around 20% of the patients do not respond to psychological treatment. complementary treatments are needed. as ptsd implied autonomic nervous system (ans) dysfonction, complementary treatment focusing on ans regulation, as welle as musicotherapy, may have an interest.

the aim is to evaluate the impact of musicotherapy on ptsd symptoms, and severity using a rct symptoms will be evaluated using questionaires (pcl and quality of life) severity will be measured using neurological soft signs assessment, connectomic functions and ans regulation

Eligibility criteria:
inclusion criteria: * ptsd exclusion criteria: * neurological diseases * addiction

Keywords: effective connectomic neurological soft signs
lymphocyte sub-populations and auto immune diseases

Conditions: Autoimmune Diseases

Summary: to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases.

the goal of this study is to determine if artificial intelligence allow to detect lymphocyte subpopulations specific of diseases (such as primary sjogren' syndrome and systemic lupus erythematosus) among patients with suspicion of autoimmune diseases. all patients who had an evaluation of their lymphocyte subpopulations between january 2010 and december 2016 will be included in a retrospective analysis.

Eligibility criteria:
inclusion criteria: * autoimmune or infectious disease exclusion criteria: * no
the affect of hemostasis technique during laparoscopic ovarian cystectomy on future fertility

Conditions: Cyst Ovary

Summary: patients undergoing elective laparoscopic ovarian cystectomy will be recruited and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the surgiflo group. patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including follicle stimulating hormone (fsh), lutenizing hormone (lh), estrogen (e2), progesterone and anti-mullerian hormone (amh) levels, and sonographic evaluation of ovarian volume and antral follicle count.

patients undergoing elective laparoscopic ovarian cystectomy will be recruited after signing an informed consent, and randomly divided into 2 groups according to intervention technique-half will be allocated to the bipolar coagulation group and half to the surgiflo group. patients will be assessed both pre-operatively and 6 months post-operatively by blood tests including fsh, lh, e2, progesterone and amh levels, and sonographic evaluation of ovarian volume and antral follicle count. antral follicle count will be performed on the cyst post-surgery using light microscopy. the difference in hormone levels, especially amh reflects the damage done during surgery to the ovarian reserve. sonographic signs including a decrease in ovarian volume and antral follicle count also reflect the damage done during surgery to the ovarian reserve.

Eligibility criteria:
inclusion criteria: * female patients with benign ovarian cysts that are interested in future fertility ages 18-44. exclusion criteria: * female patients with malignant ovarian cysts/masses.
ethanolic extract of aloe vera versus chlorohexidine as cavity disinfectant.

Conditions: Dental Caries

Summary: this randomized clinical trial will be conducted to compare the efficacy of ethanolic extract of aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of streptococcus mutans (sm) and lactobacilli (lb).

dental caries remains to be a major oral health problem afflicting people, young and old, especially in developing and underdeveloped countries. though dentistry has magically developed with newer materials and newer techniques, dental caries remains a disease of great prevalence. the prevention and control of caries necessitates the elimination of cariogenic bacteria that produce acids responsible for the decrease of ph and starting the process of demineralization. while the goal of restorative treatments for dental caries is to remove the infected dentin and fill the area with a suitable restorative material, failure to remove the infected teeth surface totally and achieve complete sterilization of the cavity can lead to microleakage, increased pulp sensitivity, pulpal infection and secondary caries that necessitate replacement of restoration. therefore, after removal of the carious dentin it is important to eliminate any remaining bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin junction, or in the dentinal tubules. but unfortunately, no definitive and reliable criteria are available to ensure the complete removal of carious tooth structure. many investigations have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin. due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant and posing a serious threat in rendering successful treatment of the diseases. with the rise in bacterial resistance to various synthetic antimicrobial agents, there is a considerable interest and a growing trend in the field.

Eligibility criteria:
inclusion criteria: * • patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch. * age range 20-50 years. * systematically health. * adults who were able to give informed consent. * teeth with radiographic evidence of carious lesion that penetrated at least the inner one half of the dentin thickness. exclusion criteria: * • patients with clinical and radiographic signs of pulpal involvement. * patients unable to return for recall appointments. * inability of a patient to give informed consent. * teeth with clinical and radiographic sign of pulpal involvement. * teeth where isolation with a rubber dam was not possible
longitudinal, prospective, french, multicenter cohort study on pancreatic radiofrequency

Conditions: Pancreatic Tumor

Summary: the purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to recist 1.1.), 5 years after the end of treatment.

this is a prospective, longitudinal, open, non-randomized, non-interventional, multicenter study on ultrasound-guided radiofrequency endoscopy for the treatment of pancreatic tumours. the study will be offered prospectively to all patients in need of treatment. they will be taken care of in accordance with current practice. the patient will be seen again 7 times after the end of the pancreatic radiofrequency (which will include one or two sessions): the follow-ups will be done according to current practice on d15 ± 7 days, m6 ± 14 days, m12 ± 1 month then annually until m60 ± 1 month. the study consists to evaluate the oncological efficacy at 5 years of pancreatic radiofrequency delivered by means of a needle guided by ultrasound endoscopy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old; * patient to be treated for a pancreatic tumor by ultrasound-guided rf with a fine needle; * indication of pancreatic radiofrequency validated in a multidisciplinary consultation meeting; * patient able to understand the information related to the study; * patient accepting study follow-up visits; * patient having been informed and agreeing to participate in the study. exclusion criteria: * patient with a contraindication to radiofrequency treatment; * pregnant or breastfeeding women
effect of midodrine on hvpg in advanced chronic liver disease

Conditions: Chronic Liver Disease

Summary: * primary objective: hvpg response after administration of midodrine as defined by decrease in hvpg by \> 20 % from baseline or to less than equals to 12 mmhg. * secondary objectives: change in hvpg, svr, heart rate, cardiac output, cardiac index, blood pressure (systolic, diastolic and mean). methodology: consecutive patients of chronic liver disease in the institute (admitted or coming to opd) as per the inclusion and exclusion criteria will be studied. * study population: patients of advanced chronic liver disease admitted or opd patients in ilbs * study design: a single arm interventional study * study period: 6 months * inclusion criteria: i) cld with grade iii ascites with na \< 130 / systolic bp \< 90 / type 2 hrs(n=30 ) (ii) aclf (apasl criteria) with na \< 130 / systolic bp \< 90 / aki (n=30) * exclusion criteria: age \ 75, pregnancy, splanchnic venous thrombosis, hcc, he, significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic renal disease, peripheral vascular disease. * sample size with justification: this is a pilot study where a total of 60 patients will be enrolled - 30 each in the two groups. * intervention: hvpg will be done in these patients at baseline and then after 3 hours of 10 mg of midodrine tablets. monitoring and assessment: various parameters will be assessed during the procedure before and after 3 hours of midodrine such as hvpg (whvp - fhvp), svr, heart rate, cardiac output, cardiac index, blood pressure (systolic, diastolic and mean), spo2. - statistical analysis: continuous data will be represented by mean ± sd or median ± iqr. categorical data will be represented by n = frequency (%). categorical data will be analyzed by chi square test or fisher exact test as appropriate. continuous data will be compared by using student t test or mann whitney test (when applicable). the change in hvpg will be analyzed by using paired t test or wilcoxon signed rank test. the % change in the individual group will be compared to see the significance between the groups. the significance will be seen at 5%. * adverse effects: same as for hvpg (mild pain / hematoma at the puncture site, transient arrhythmias). midodrine has got good safety profile and is used in patients of advanced chronic liver disease. * stopping rule of study: nil expected outcome of the project: if result shows that hvpg is decreased by midodrine, then it can be used in place of beta blockers when they are contraindicated or have the potential of causing adverse effects.


Eligibility criteria:
inclusion criteria: - i) cld with grade iii ascites with na \< 130 / systolic bp \< 90 / type 2 hrs(n=30 ) ii) aclf (apasl criteria) with na \< 130 / systolic bp \< 90 / aki (n=30) exclusion criteria: 1. age \ 75, 2. pregnancy, 3. splanchnic venous thrombosis, 4. hepatocellular carcinoma, 5. hepaticencephalopathy, 6. significant cardiopulmonary disease, 7. uncontrolled diabetes, 8. hypertension, 9. intrinsic renal disease, 10. peripheral vascular disease.
a research in pharmacogenomics and accurate medication of risperidone

Conditions: Schizophrenia; Mental Illness

Summary: risperidone is a selective monoamine receptor antagonist. it plays an antipsychotic effect by antagonizing 5-ht2 / d2 receptor. as a second-generation antipsychotic drug, risperidone is metabolized to 9-hydroxy risperidone in the body very quickly. there are individual differences in the pharmacokinetics and pharmacodynamics of risperidone. for example, cyp2d6 genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting the type and dose of medication to treat schizophrenia. in this study, we will verify the correlation between the polymorphisms of genes related with risperidone drug metabolites, drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in chinese population, providing basis for clinical rational use of risperidone.

subjects with schizophrenia will be recuited from several sub-centers. the relevant gene polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored through drawing blood samples at 0h, 6h, d27 and d56 of the risperidone drug administration. information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum prolactin levels) will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * patients that meet with dsm-iv-tr schizophrenia diagnostic criteria, based on concise international neuropsychiatric interview (mini); * patients who have never received risperidone treatment or who need re-administration of risperidone after previous treatment with risperidone; * subjects and / or their guardians who agree to sign the informed consent. exclusion criteria: * patients who use cyp2d6 or cyp3a4 inducers or inhibitors as treatment drugs; * patients with hepatic insufficiency; * patients with renal insufficiency; * patients who use other drugs that interact with risperidone; * certain patients that the researchers consider to be unsuitable for the clinical trail.
comprehensive lifestyle improvement program for men with prostate cancer

Conditions: Prostate Cancer

Summary: this study is an investigator initiated clinical study. a prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 30 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

introduction * androgen deprivation therapy (adt) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (pca). * adt for pca is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. this reduces quality of life (qol) and potentially affects mortality. * there is paucity of data regarding comprehensive lifestyle interventions in men on adt for pca. existing studies used non-standardized interventions or lack data on metabolic risk factors. * clipp is designed to address these gaps by using an intervention modelled after the diabetes prevention program (dpp), a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer. intervention: * 24 weeks * health coaching weekly * serum \& urine baseline, week 12 and week 24 * anthropometric measures * questionnaires * dual-energy x-ray absorptiometry (dxa) at baseline and week 24

Eligibility criteria:
inclusion criteria: * diagnosed with prostate cancer stage i, ii or iv * on androgen deprivation therapy with last 5 years * willing to participate in a lifestyle modification program * willing to modify diet and eating practices * willing to participate in blood collection, urine collection and measurements * minimum of 30 days since participating in another study/trial * english speaking * 40 years of age or older exclusion criteria: * currently participating in another study or trial * currently in hospice * inability to walk two city blocks * inability to comprehend informed consent or procedural requirements * digestive diseases (ibd, diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
impaact p1074: long-term outcomes in hiv-infected infants, children, and adolescents

Conditions: HIV Infections

Summary: this study will examine the long-term effects of hiv infection, highly active antiretroviral therapy (haart), and experimental treatments on children who participated in pactg 219c or select impaact studies.

the use of haart has been important in extending the lives of people with hiv infection. however, prolonged use of haart may have long-term consequences. in addition, people participating in clinical trials using experimental therapies to treat hiv infection may experience negative health outcomes. the purpose of this study is to identify the long-term effects of hiv infection, haart, and experimental treatments in infants, children, and adolescents. this study will enroll children who participated in pactg 219c or various impaact studies. there will be no study visits specifically for this study. researchers will review participants' medical records annually and collect information on illnesses, medications, cd4 cell count and viral load data, and body measurements.

Eligibility criteria:
inclusion criteria: * past or current documentation of a confirmed diagnosis of hiv-1 infection defined as two separate peripheral blood specimens from different days, and each specimen must be positive. more information on this criterion can be found in the protocol. * hiv-infected infants, children, or adolescents who participated in pactg 219c during 5/1/06-5/31/07 and are not currently participating in ongoing long-term follow-up (ltfu) studies (e.g., pediatric hiv/aids cohort study adolescent master protocol \[phacs amp\], legacy). please refer to the impaact website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org). or * hiv-infected infants, children, and adolescents at domestic sites who have participated in or are currently participating in impaact treatment studies (including studies that have rolled over from the pactg into impaact) designated by the impaact network executive committee (nec) for subsequent ltfu in this study, and are not currently participating in ongoing ltfu studies. please refer to the impaact website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org). * parent or legally-accepted representative/guardian is able and willing to provide signed informed consent for minors (unless child has emancipated minor status) exclusion criteria: * current participation in other ongoing ltfu studies (e.g., phacs amp, legacy). please refer to the impaact website for the current list of studies or contact the protocol team (actg.teamp1074@fstrf.org).
abdominal muscle thickness in mechanically ventilated patients

Conditions: Muscle Weakness; Weaning Failure

Summary: the purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. in addition the reliability of the sonographic measurements will be assessed.

the purpose of the study is to determine to what extent the abdominal muscles contribute to airway pressure, in order to investigate the correlation between muscles weakness and extubation outcome in mechanically ventilated patients. in addition the reliability of the sonographic measurements will be assessed.

Eligibility criteria:
inclusion criteria: * greater than 18 years old * patients requiring invasive mechanical ventilation including patients with endotracheal tube and tracheotomies exclusion criteria: * patients with a previously diagnosed neuromuscular disorder (acute or chronic) * behavioural agitation * patients who are not awake and cooperative * previously enrolled in the study

Keywords: abdominal muscles spontaneous breathing trial critically ill patients
a retrospective study on drug induced liver injury in china

Conditions: Drug-Induced Liver Injury

Summary: this is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

this is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes. it investigates medical records of patients who were hospitalized during 2012 to 2014. those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.

Eligibility criteria:
inclusion criteria: * any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature. * the drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature. exclusion criteria: * confirmed non-drug induced liver injury. * insufficient clinical data supporting the diagnosis of drug-induced liver injury. * liver injury resulted from poisons and chemicals.

Keywords: drug-induced liver injury dili