Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of melatonin pr and clonazepam in patients with rem sleep behavior disorder in parkinson disease

Conditions: REM Sleep Behavior Disorder; Parkinson Disease

Summary: the purpose of this study is to determine whether melatonin prolonged-release (pr) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (rbd) of patients with parkinson's disease (pd).

rbd is one of the representative non-motor symptoms of pd. patients with rbd show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. these can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of rbd. clonazepam has been used for treatment of choice of rbd. however, the efficacy of clonazepam is not proven in the clinical trial. clonazepam has several side effects that could be problematic in pd patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. melatonin is a second-line treatment option for rbd, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on rbd. finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of rbd.

Eligibility criteria:
inclusion criteria: * subject was enrolled voluntarily and understood the contents of this clinical trial * subject was diagnosed as parkinson disease (pd) * hoehn and yahr (h\&y) stage 1, 2, or 3 * existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (rbd) of the participant * rbd frequency is one or more per week * existence of rbd by answering "yes" to the question (rbd-1q): "have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?" * good compliance for reporting pgi scores and sleep diary exclusion criteria: * existence of cognitive decline hard to participate in the clinical trial * hypersensitivity to melatonin or clonazepam * previous melatonin or clonazepam treatment within 1 month * changing anti-parkinsonian medications within 1 month * current treatment with sedatives or hypnotics at bedtime * diagnosed as epilepsy or current treatment with anti-epileptic drugs * severe trauma history due to rbd * lactating, pregnant, or possible pregnant * subject has confusion or visual hallucination in daytime * diagnosed as obstructive sleep apnea or severe snoring * diagnosed as other parasomnia * presence of severe psychiatric illness * alcoholics or drug abuser * myasthenia gravis * acute narrow-angle glaucoma * prior participation to other clinical trials within 3 months * presence of severe comorbidities or a cancer * existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians

Keywords: rem sleep behavior disorder parkinson disease randomized controlled trial clinical trial melatonin clonazepam
effect of different vv ecmo flows on lung perfusion monitored by eit

Conditions: Critical Illness

Summary: the purpose of this study is to investigate the feasibility of using electric impedance tomography (eit) to monitor lung perfusion during veno-venous (vv) extracopreal membrane oxygenation (ecmo) support, as well as the effect of different ecmo flows on lung perfusion monitored by eit.

this is a monocentric obsevensional study that uses eit to monitor lung perfusion during vv ecmo support and the effect of different ecmo flows on lung perfusion as measured by eit. patients on vv ecmo who meet the withdrawal criteria as determined by clinical experts will have their ecmo flow gradually reduced. eit lung ventilation and perfusion monitoring were performed at various ecmo flows.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 and ≤ 70 years； 2. patients supported with vv ecmo for respiratory failure； 3. patients are intubated and mechanically ventilated. exclusion criteria: 1. eit contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc; 2. patients who did not sign the informed consent form; 3. pulmonary embolism; 4. pneumothorax; 5. medium to plenty of chest water; 6. atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output; 7. refractory shock; 8. severe chronic heart and lung disease has existed in the past; 9. bmi\>35 kg/m2; 10. intra-abdominal pressure \>20mmhg.

Keywords: vv ecmo eit lung perfusion
lactobacillus reuteri in management of helicobacter pylori infection in dyspeptic patients

Conditions: Helicobacter Pylori Infection

Summary: addition of l. reuteri to the standard triple therapy improves h. pylori treatment outcomes.

helicobacter pylori (h. pylori) infection is a wide spread disease and is endemic in many countries including egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . however, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . on the sight of bearing in vivo and in vitro activity against h. pylori, the use of different strains of probiotics in treatment of h. pylori may be thus justifiable, lactobacillus reuteri (l. reuteri) which through different mechanisms including production of reuterin have anti h.pylori activity have been tried in improving the eradication rates of h.pylori with contradictory results . this study is conducted to test the assumption that addition of l. reuteri to the standard triple therapy in treatment of h. pylori improves the eradication rates and clinical aspects in h. pylori infection.

Eligibility criteria:
inclusion criteria: inclusion of patients with these criteria 1. age: 18-60 years 2. any sex 3. confirmed h. pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or h. pylori antigen in stool 4. good mentality to understand aim, benefits and steps of the study 5. assumed availability during the study period 6. written informed consent exclusion criteria: * exclusion of 1. patients with chronic diseases e.g. diabetes, renal failure, cirrhosis...etc. 2. patients with malignancy. 3. patients with gall bladder disorders. 4. patients with peptic ulcer. 5. patients with prior upper git surgery. 6. patients with probiotics therapy in the last one month. 7. patients with triple therapy, antibiotics, proton pump inhibitors and h2 receptor blockers therapy within one month. 8. patients with known allergy to the used medications -

Keywords: helicobacter pylori lactobacillus reuteri dyspeptic patients eradication
clinical efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. the aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (ipf) through the observation of a large sample of clinical cases.

the aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (ipf) through the observation of a large sample of clinical cases. during the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.

Eligibility criteria:
inclusion criteria: 1. written informed consent signed; 2. age ≤75 years; 3. clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance ); 4. resting state pao2≥50mg, fvc%≥45% normal predicted value and dlco≥30% normal predicted value. exclusion criteria: 1. allergic to pirfenidone; 2. patients with serious significant pulmonary infection need anti-infection treatment; 3. patients who has taken interferon, penicillamine or other agents for the treatment of ipf; 4. patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month; 5. patients who has taken immunosuppressants in the past 1 month; 6. patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months; 7. patients with malignant tumor in the past 5 years; 8. participated in other clinical trials in the past 3 months; 9. patients with serious heart disease(nyha class ⅲ-ⅳ), liver disease(alt or ast 2 times above the upper level of normal value range), kidney disease(cr above the upper level of normal value range); 10. pregnant or lactating women; 11. the investigator assessed as inappropriate to participate in this clinical trial.
efficacy and mechanisms of tus on cognitive deficits in schizophrenia: based on the hippocampal-prefrontal circuit

Conditions: Cognitive Deficit in Schizophrenia

Summary: cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome. prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/gaba imbalances may lead to cognitive deficits. based on the current background and our previous studies, it has been proved that tus can modulate neural excitability and plasticity in the hippocampus. in this double-blind, randomized study, the efficacy of different treatment options and mechanisms of tus on cognitive deficits will be investigated.

cognitive deficit is a core symptom of schizophrenia related to poorer functional outcome which remains largely treatment refractory. prior studies indicated that abnormalities in the hippocampus-prefrontal circuit and glutamate/gaba imbalances may be the root causes of cognitive deficits. transcranial ultrasound stimulation (tus), an emerging non-invasive neuromodulation technique with deep penetration ability, can modulate neural excitability and plasticity in the hippocampus. this is a 4-week double-blind randomized trial of tus for cognitive deficits in schizophrenia, with either left hippocampus or left dorsolateral prefrontal cortex (dlpfc) or both targeted. this study aims to determine the efficacy of tus and to reveal its underlying neural mechanism, especially with the hippocampus-prefrontal circuit, by means of tus, as to assess cortical inhibition and excitability, eeg source imaging, and multi-model mri. neuropsychological assessments will also be conducted to develop the optimized treatment strategy. the study points to a novel and promising therapeutic neuromodulation approach that may improve the functional outcome of schizophrenia, which has been the main cause of mental disability.

Eligibility criteria:
inclusion criteria: * meet the dsm-5 diagnostic criteria for schizophrenia ; * age18-50, right-handed, han nationality; * presence of cognitive deficit: defined as d' value \<0.5 in associative memory test; * be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more; * written informed consent; exclusion criteria: * current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnancy or lactation; * uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.; * history of mect or other physical therapy within 6 months; * history of epilepsy, or epileptic waves on the baseline eeg; * ruled out share antiepileptic drugs (carbamazepine, valproic acid salt) or larger doses of benzodiazepine drugs (diazepam \> 10mg/day, clonazepam \> 2mg/day etc.), if necessary, remain unchanged during the course of treatment; * contraindications to tus and mri are present.

Keywords: schizophrenia; cognitive deficit; transcranial ultrasound stimulation; hippocampus- prefrontal circuit
evaluation by hr-pqct of bone microarchitecture changes in patients with rheumatoid arthritis under anti-tnf therapy.

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is the most common chronic inflammatory joint disease in adults and is characterized by chronic inflammation of the joints leading to their destruction, resulting in a major loss of function. the investigators propose a pilot study for studying changes in bone microarchitecture with high resolution peripheral micro computerized tomography (hr-pqct) in patients with ra treated with anti-tnf(tumor necrosis factor), with the measurement of micro-architectural parameters in subchondral area near an inflammatory joint during the first 12 months of initiation of an anti-tnf therapy (infliximab®, etanercept®, adalimumab®).


Eligibility criteria:
inclusion criteria: * men from 18 to 65 years old * women from 18 years old to menopause * patient with a polyarthritis rheumatoid no controlled by the usual treatment (das28\>3) * patient affiliated or beneficiary of a national insurance system * patient with signed consent exclusion criteria: * concomitant osseous disease (paget's disease, osteomalacia...) * endocrinopathy defined on biological criteria (cushing's disease, hyperthyroidism, hypogonadism...) * patients under protection of justice * refusal consent
impact study: investigating microbial pathogen activity of copper textiles

Conditions: Critically Ill

Summary: the purpose of this study is to assess the impact of copper linens on hospital acquired infections and drug resistant bacteria.

healthcare-associated infections (hais), particularly those due to multidrug-resistant organisms (mdros), are of great clinical and public health concern. although evidence-based prevention strategies have resulted in some success in curtailing hais, novel approaches are needed to achieve further reductions. efforts to curb the emergence of mdros have been largely unsuccessful. thus, new strategies to address mdros are urgently needed. this grant is comprised of two complementary studies that focus on identifying innovative approaches to more effectively prevent hais and curtail further emergence of mdros. we will conduct a randomized controlled trial (rct) to assess the efficacy of copper oxide-impregnated textiles in preventing hais and mdros as well as in reducing environmental microbial contamination. we hope to provide critical information to inform the development of novel strategies, and enhance the impact of existing strategies, to successfully address hais and mdros. for approximately four months the hospital is conducting a research study to learn about the possible impact of copper linens in reducing hospital acquired infections. some rooms will have copper linens (group 1) and some rooms will have regular linens (group 2). the linens will be comprised of the top and bottom sheets, pillowcase cover, and hospital gown. patients in both groups will be asked to provide samples during their stay in the icu. for both study groups, the linens will be sampled twice after they are placed. this will occur on 2 consecutive days. at the same time, study staff will take samples from several areas of the room (the hand rails, overbed table, nurse call button). patients will also be asked to allow the research team to obtain swabs of the nose, per-rectal area, armpit and groin. these swabs will be performed on their first day enrolled into the study, then 4 days later, and every week until icu discharge.

Eligibility criteria:
inclusion criteria: * hospital inpatients * admission to intensive care unit * hospital admission at least 48 hours exclusion criteria: * hospital admission less than 48 hours
preventing learning problems in young children: a public health and physician-based outreach

Conditions: Developmental Disabilities; Language Development Disorders

Summary: this study will evaluate a program to prevent learning problems in children. the program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.

this study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. the goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. the intervention is based on a public health/primary care partnership and combines mailed parent-completed ages \& stages questionnaires (asq), a monthly mailed age-paced parenting newsletter (building blocks) and corresponding developmental toys (bb), and a reach out and read (ror) physician-based distribution of children's books. families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an asq/bb+ror group, an ror-only group, or a no intervention control group. outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to early intervention programs. baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.

Eligibility criteria:
inclusion criteria * attend participating pediatric clinic (serving poor, largely black, and hispanic communities) * family with child 4 to 7 months of age at enrollment * english- or spanish-speaking exclusion criteria * developmental delay * eligible for early intervention program

Keywords: public health primary care parenting education child rearing parenting newsletters child development language delay
a retrospective analysis of neevo® and neevodha® compared to a standard prenatal vitamin in anemia during pregnancy

Conditions: Anemia in Pregnancy; Pre-eclampsia

Summary: this study is a multi-site, retrospective chart review to determine the effect of neevo® or neevodha® (with higher folate and b12) versus standard prenatal vitamins on hemoglobin (hgb) levels in pregnant women throughout the course of pregnancy. neevo® is a prescription medical food indicated for the dietary management of women under a doctor's care who face high risk pregnancies, older overactive bladder (ob) patients and patients unable to fully metabolize folic acid. data will be collected from existing patient charts of subjects administered neevo® or neevodha® daily compared to subjects administered a prenatal vitamin daily.


Eligibility criteria:
inclusion criteria: * pregnant females, age 21-39, who received either neevo®/neevodha® or another standard prenatal vitamin (prenatal vitamins must contain ≤1 mg folic acid, 27-35mg iron, and ≤12mcg vitamin b12). * clinical diagnosis of pregnancy must have been made at ≤12 weeks of pregnancy, and delivery must have occurred on or after january 1, 2008 and on or before march 31, 2010 * subjects must have been compliant in taking neevo®/neevodha® or other prenatal vitamin exclusion criteria: * subjects should not have taken prenate®, prenate®dha, or prenate® elite, which are l-methylfolate-containing prenatal vitamins. * the following supplements within 2 months of diagnosis of pregnancy: b12 injection; \> 35mg iron; \> 1.2 mg of folate; or a l-methylfolate product that is not a prenatal vitamin such as life extension methylfolate, prothera methylfolate, thorne 5-mthf, metanx®, deplin®, cerefolin®, or cerefolinnac® * history of leukemia or any anemia other than iron deficiency anemia or; * taking any iron supplement (in addition to the prenatal vitamin) prior to week 22

Keywords: neevo neevo dha l-methylfolate anemia during pregnancy folic acid vitamin b12 prenatal vitamins hemoglobin iron deficiency pregnancy
evaluation of 24-hour intragastric ph using esomeprazole, lansoprazole, and pantoprazole in hispanic patients with gerd

Conditions: Gastroesophageal Reflux Disease

Summary: this study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of hispanic origin who have gerd.


Eligibility criteria:
inclusion criteria: * signed informed consent * males and females ages 18-69 who are of hispanic origin * symptoms of gerd, defined as heartburn at least 2 times a week on average over the last 3 months exclusion criteria: * female patients who are pregnant or breastfeeding * known intolerance or lack of response to proton pump inhibitors (ppis) such as nexium, prevacid, or protonix * current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery

Keywords: gerd acid reflux heartburn ppi hispanic
effect of simvastatin on the prognosis of primary primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis

Summary: this is a randomized, double-blind, placebo controlled multicenter study. a total of 700 patients will be included. the study will include patients with primary sclerosing cholangitis (psc) for daily intake of 40 mg simvastatin/placebo for 5 years. the aim is to study effect of prognosis of psc by long term intake of simvastatin. outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices. subjects will be randomized (1:1) between simvastatin and placebo.


Eligibility criteria:
inclusion criteria: * psc verified by cholangiography or liver biopsy, with or without irritable bowel disease (ibd). * men and women between ≥18 years and ≤75 years. * written informed consent. * a magnetic resonance imaging (mri) or magnetic resonance cholangiopancreatography (mrcp) performed within 4 months prior to randomization. * colonoscopy performed within 24 months prior to randomization, if known ibd. * for women of childbearing potential efficient contraceptive. exclusion criteria: * subjects on waiting list for transplantation * transplanted subjects * previous variceal bleeding * previous hepatobiliary malignancy * subjects with secondary sclerosing cholangitis * intake of any type of statins within 3 months prior to randmization * known intolerance to simvastatin. * pregnancy or breastfeeding.
therapeutic diets in alzheimer's disease

Conditions: Alzheimer Disease

Summary: by doing this study, researchers hope to learn how the ketogenic and therapeutic lifestyles changes diets affect cognition in patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of ad by current mckhann et al. criteria * cdr global score of 0.5 or 1 * agreed cooperation from an appropriate study partner * speaks english as primary language * age 50 to 90 * no medication changes within the past 30 days exclusion criteria: * resides in a nursing home or dementia special care unit, or cannot control diet * a potentially confounding serious medical risk including insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or a recent cardiac event (i.e. heart attack, angioplasty, etc.) * participating in another clinical trial or using an investigational drug or therapy within 30 days of the screening visit * a history of renal stones
effect of peripheral laser iridotomy placement on post-operative visual function

Conditions: Glaucoma, Angle-Closure

Summary: to evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.


Eligibility criteria:
inclusion criteria: * angle-closure glaucoma * angle-closure glaucoma suspect exclusion criteria: * monocular status * previous intraocular surgery * visual acuity worse than 20/40 * prior episode of acute angle-closure glaucoma * pregnancy