Kornimate/medical-research-clean huggingface dataset:
the study of atypical antipsychotics-induced metabolic disturbances

Conditions: Schizophrenia; Antipsychotics

Summary: schizophrenia is one of the most severe mental illnesses. the antipsychotic drugs, introduced in early 1950s, have revolutionized the treatment of schizophrenia. about 2 to 4 times as many patients relapse when treated with a placebo as do those treated with antipsychotic drugs. for these medications to be maximally beneficial, they must have an acceptable side effect profile and be taken as prescribed. one untoward effect of many antipsychotic drugs is weight gain. the extent of weight gain apparently varies by drug, which may be because of drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other neurotransmitter systems. obesity is a threat to health and longevity. weight gain may also cause patients taking antipsychotic medication to discontinue their medication, which may predispose them to relapse. the pattern of weight gain and metabolic disturbance may vary between the different antipsychotic agents. the underlying mechanism and treatment of these adverse metabolic effects remain unclear. this study will recruit 60 schizophrenic patients during. the patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or risperidone). the assessment of metabolic profile will be monitored at baseline, week 2, week 4, and week 8. the measurements include anthropometrical parameters, body composition, glucose level, insulin level, lipid profile, and leptin level. intra-venous glucose tolerance test will be used to assess the insulin secretion and insulin sensitivity. this proposal broadly aims to discover the underlying mechanism of antipsychotics induced metabolic disturbance and develop efficient treatment to correct it.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia * age 18-60 years exclusion criteria: * received any sgas prior to this study * medical conditions that may confound glucoregulatory assessment * pregnancy

Keywords: schizophrenia antipsychotics glucose homeostasis metabolic disturbance
amoxicillin clavulanate in treatment of acute otitis media

Conditions: Acute Otitis Media

Summary: this is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of city of turku, finland. the study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). the hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.


Eligibility criteria:
inclusion criteria: * acute otitis media * age 6 - 35 mo exclusion criteria: * spontaneous perforation of the tympanic membrane and drainage * systemic or nasal corticosteroid therapy within 3 preceding days * antihistamine therapy with 3 preceding days * oseltamivir therapy within 3 preceding days * allergy to amoxicillin/penicillin * tympanostomy tube present in tympanic membrane * clinical evidence of infection requiring systemic antimicrobial treatment * documented ebstein barr virus infection within 7 preceding days * down syndrome or other condition to affect middle ear infections * known immunodeficiency * vomiting or another symptom to violate per oral dosage * poor parental co-operation due to language or other reasons * use of any investigational drugs during the 4 preceding weeks
melatonin effects on cardiovascular disease mechanisms in the menopause transition: a randomized clinical trial

Conditions: Perimenopause; Hypertension

Summary: the purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.


Eligibility criteria:
inclusion criteria * age 40-55 years old * female individuals with intact uterus and at least one ovary * currently in the menopause transition o defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with the stages of reproductive aging workshop (straw) criteria:6 a difference of ≥7 days in the length of consecutive menstrual cycles which recurs within 10 cycles from the first occurrence (early menopause), or 2 to 12 months of amenorrhea (late perimenopause) * hypertension o defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office sbp/dbp ≥130/80 mmhg * on stable medical regimen (≥ 2 months) if taking other medications exclusion criteria * prescription sleeping medications or melatonin supplementation * pregnant or lactating * night shift work * current or recent (within the past 2 months) use of hormonal contraceptives * current or recent (within the past 2 months) use of hormone replacement therapy * on prescription aspirin * severe lactose intolerance * history of substance use disorder * history of suicidal ideation * history of clinically diagnosed anemia or low hemoglobin levels (\<11.6 g/dl) within the past 12 months * active cancer * severe daytime sleepiness (score \>15 at the epworth sleepiness scale) * current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators * inability to provide written consent and/or to speak and read english * any other medical, geographic, or social factor making study participation impractical
the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants

Conditions: Preterm Infant; Music; Near-infrared Spectroscopy; Electroencephalogram

Summary: music has been consistently shown magic power in brain plasticity. several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. the investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

previous studies of music therapy have made some achievements for adult parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. for newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. so far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.

Eligibility criteria:
inclusion criteria: * postmenstrual age of 32-36+6 weeks. * appropriate weight for gestational age. * to have signed an informed consent to participate in the study. * have reached clinical stability. exclusion criteria: * have nervous system diseases or obvious nervous system symptoms. * severe congenital diseases. * the maintenance of sedative or analgesic drugs. * support with mechanical ventilation.
changing opioid users' negative attitudes toward medication assisted treatment

Conditions: Opioid Use Disorder

Summary: in this treatment development project, the investigators propose to develop and assess the feasibility and acceptability of a narrative-based video intervention and accompanying workbook (entitled matters: medication assisted treatments: telling real stories) designed to be used by people in inpatient opioid detoxification. using the health belief model as a framework, videos will provide information about the uses and outcomes of medication assisted treatments (mats) compared to other or no post-detoxification treatment through the use of narratives from real people's lives.


Eligibility criteria:
inclusion criteria: 1. currently undergoing inpatient opioid detoxification; 2. qualify for use of one or more mats; 3. have health insurance; 4. able to read and speak english; 5. aged 18 or older; 6. no suicide ideation or behavior requiring immediate attention; 7. live in the rhode island or massachusetts area and have a working telephone; 8. able to provide two contact persons to verify location and in case we are unable to reach the participant during the study; 9. do not have probation/parole requirements that might interfere with protocol participation.
efficacy and safety of bia 9-1067 in idiopathic parkinson's disease patients.

Conditions: Parkinson's Disease

Summary: parkinson's disease (pd) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year. bia 9-1067 is currently being developed by bial (portela \& cª,s.a.) to be used in addition to l-dopa (levodopa) /carbidopa or l-dopa (levodopa) / preparations in pd patients. promising results have been obtained for bia 9-1067 in previous studies.

this study aims to demonstrate the efficacy and safety of bia 9-1067 used in addition to l-dopa/ddci to control the "wearing-off" phenomenon in patients with pd. ddci (dopa decarboxylase inhibitors): benserazide and carbidopa

Eligibility criteria:
inclusion criteria: 1. able to comprehend and willing to sign an informed consent form. 2. male and female subjects between 30 and 83 years old, inclusive. 3. diagnosed with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnostic criteria for at least 3 years. 4. disease severity stages i-iii (modified hoehn \&yahr staging) at on. 5. treated with l-dopa/ddci for at least 1 year with clear clinical improvement. 6. treated with 3 to 8 daily doses of l-dopa/ddci, which can include a slow-release formulation. 7. on a stable regimen of l-dopa/ddci and other anti-pd drugs for at least 4 weeks before screening. 8. signs of "wearing-off" phenomenon (end-of-dose deterioration) for a minimum of 4 weeks before screening with average total daily off time while awake of at least 1.5 hours, excluding the early morning pre-first dose off, despite optimal anti-pd therapy (based on the investigator's judgment. exclusion criteria: 1. non-idiopathic pd (atypical parkinsonism, secondary \[acquired or symptomatic\] parkinsonism, parkinson-plus syndrome). 2. dyskinesia disability score \>3 in the unified parkinson's disease rating scale updrs) sub-section iv a, item 33. 3. severe and/or unpredictable off periods. 4. treatment with prohibited medication: entacapone, tolcapone, neuroleptics, venlafaxine, mao inhibitors (except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or rasagiline up to 1mg/day), or antiemetics with antidopaminergic action (except domperidone) within the month before screening. 5. treatment with apomorphine within the month before screening or likely to be needed at any time during the study. 6. dosage change of concomitant anti-pd medication within 4 weeks of screening. 7. previous or planned (during the entire study duration, including the ol period)deep brain stimulation. 8. previous stereotactic surgery (e.g. pallidotomy, thalamotomy) for pd or with planned stereotactic surgery during the study period. 9. any investigational medicinal product within the 3 months (or within 5 half-lives, whichever is longer) before screening. 10. any medical condition that might place the subject at increased risk or interfere with assessments.

Keywords: parkinson pd wearing-off levodopa/ddci
effects of additional mgso4 30 mg/kgbw intravenous and ketorolac

Conditions: Anesthesia; Pain, Postoperative; Surgery; Opioid Use

Summary: this study aims to compare two groups of post-orthopedic patients who received a standard regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and adjuvant magnesium sulfate 30mg/kgbw 1 hour preoperatively. if it is proven useful, it is hoped that pain will be more controlled, reduce pain complications, reduce treatment costs, and reduce the duration of hospital stays.

the study design used was a randomized controlled trial (rct) with double blinds. double blind because neither the patient, the lead investigator, nor the investigator on record knew the drug or placebo that was administered. research subjects were selected consecutively in patients who will undergo lower extremity surgery at the cipto mangunkusumo national central general hospital. forty-eight research subjects will be divided into two groups, namely the group given intravenous magnesium sulfate 30 mg/kgbw and the group given a placebo. research subjects were randomized by type of surgery using randomization software by research assistants. the results of randomization were not known to the patient, the principal investigator, or the researcher taking notes. this study aims to determine the effect of adding 30 mg/kg body weight of intravenous mgso4 to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing lower extremity orthopedic surgery under general anaesthesia. * patients aged 18-60 years. * physical status asa 1-3 * willing to participate in research. exclusion criteria: * patients who are hemodynamically unstable. * patients with decreased renal function * patients with skeletal muscle disorders. * patients with ketorolac allergy * patients with morphine allergy
prognostic factors affecting outcomes in multivisceral en bloc resection for colorectal cancer

Conditions: Colorectal Neoplasms

Summary: determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.

between january/2009 and february/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. estimated local recurrence, and overall survival were compared using the log rank method, and cox regression analysis was used to determine the independence of the studied parameters.

Eligibility criteria:
inclusion criteria: * t4 colorectal cancer - exclusion criteria: * non primary colorectal cancer -
impact of c242t polymorphism of p22phox in diabetic type1 nephropathy

Conditions: Type 1 Diabetes Mellitus; Diabetic Nephropathy

Summary: the physiopathology of diabetic nephropathy (dn) is unclear. to investigate risk factor, the investigators choose to look about some oxidative stress genes. today a one-gene explanation is not really possible. so the theory of some genetic predisposition to dn is more likely. the aim of the study is to look about the association of the c282t polymorphism of p22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (nadph oxidase) in the occurrence of dn. to follow the oxidative stress pathway of the dn, the investigators also investigate three other polymorphisms: -429 t/c, -374 t/a polymorphism of advanced glycation end-products receptor (ager) and the p.arg261gln polymorphism of the 12 lipoxygenase (alox 12). discordant data suggest a link between the first 2 polymorphisms and dn. the last polymorphism is correlated to albuminuria in diabetic patients.

to avoid confounding factors, we choose type 1 diabetic patients. we plan, with the data of literature a number need to be significative with a power of 80% and an alpha risk at 5%, the inclusion of 160 patients for our primary analyze of p 22 phox. those patients are included consequentially from the diabetic consultation of the university hospital of grenoble, if they have a history of more than 20 years of diabetes. those patients have been separated according to the existence of dn, and their polymorphism. then we estimate with the fisher test the prevalence of dn in risky patient, and the prevalence of the risky phenotype in the nephropathic patients. then we investigate with the same statistical test the -429 t/c,he -374 t/a ager and p.arg261gln 12 alox polymorphisms.

Eligibility criteria:
inclusion criteria: * caucasian * diabetic type 1 * older than 18 years old * written consent exclusion criteria: * other etiology of diabetic nephropathy * pregnancy * other type of diabetes

Keywords: diabetic nephropathy cyba p22phox rage 12lox genetic type 1 diabetes mellitus with diabetic dermatitis caucasian more than twenty years of diabetes duration older than 18 years no nephropathy other than diabetic nephropathy
relationship between grip endurance, disability of upper extremity and quality of life in patients with ra

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to investigate the relationship between grip endurance, disability of upper extremity and quality of life in patients with rheumatoid arthritis.

upper extremity functions affect the quality of life at different levels in patients with rheumatoid arthritis (ra). in the current literature; it has been shown that grip endurance is associated with upper limb functions. however, there is no study investigating the relationship between grip endurance and quality of life in patients with ra. the purpose of this study is to investigate the relationship between grip endurance, disability of upper extremity, and quality of life in patients with ra.

Eligibility criteria:
inclusion criteria: * ra patients were classified according to the acr 2010 criteria. * taking regular medication. exclusion criteria: * having a history of trauma or surgery in the upper limb. * having neurological, cognitive, or psychiatric diseases.

Keywords: grip endurance, dash, quality of life, rheumatoid arthritis.
clinical benefit of a mouthrinse for the treatment of dentine hypersensitivity

Conditions: Dentin Sensitivity

Summary: this study is to evaluate the benefit and tolerability of a mouthrinse (iqp-olp-101) in the treatment of dentine hypersensitivity.


Eligibility criteria:
inclusion criteria: 1. at least one hypersensitive tooth in everyday life after pav 1 in-office visit 2. at least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after pav 1 visit 3. at least one tooth with dentine hypersensitivity to air stimulation → vas ≥ 40mm at study entry 4. any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root 5. for subjects entering the study at stage par-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery 6. age ≥ 18 years and ≤ 75 years 7. willing and able to attend the on-study visits 8. willing and able to understand and to follow the study procedures and instructions 9. good oral hygiene throughout the study 10. written informed consent before participation in the study 11. subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage par-control) exclusion criteria: 1. hypersensitivity only due to sweets 2. allergic reactions to any ingredients of inqpharm mouthrinse e.g. chlorhexidine, zinc lactate 3. professional desensitizing therapy during the previous 3 months; gluma (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months 4. chronic systemic anti-inflammatory and analgesic medications 5. systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.) 6. teeth or supporting structures with any other painful pathology or defect 7. subject with poor health conditions 8. concurrent participation in another clinical trial 9. pregnant or lactating women
transcriptomic profile of adipose tissue following n-3 polyunsaturated fatty acid (pufa) supplementation

Conditions: Polycystic Ovary Syndrome

Summary: adipose tissue is a central organ involved in mediating metabolic health, and so the investigation of treatments which improve adipose tissue function is warranted. lc n-3 polyunsaturated fatty acid (pufa) have been shown to exert positive effects on adipose tissue gene expression in previous studies. however this has not been investigated in women with polycystic ovary syndrome (pcos), a population shown to display a degree of adipose tissue dysfunction. the aim of this study was to determine the impact of lc n-3 pufa supplementation on gene expression profiles of women with pcos.


Eligibility criteria:
inclusion criteria: * had a positive diagnosis of pcos as defined according to the nih criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. clinical criteria included hirsutism with a ferriman-galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (dheas) greater than the laboratory reference range. * were between the ages of 18 and 40 exclusion criteria: * were under 18 years or greater than 40 years old, * were non-caucasian * were pregnant, lactating or trying to conceive * had a body mass index (bmi) \ 50kg/m2 * had a recent illness or any chronic illness likely to influence results * were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents * were taking nutritional supplements * consumed greater than 2 portions of oily fish per week

Keywords: pcos
evaluation of safety and efficacy of using seraffix ltb - (laser tissue bonding) system

Conditions: Dehiscence, Surgical Wound

Summary: the purpose of this study is to evaluate the safety and effectiveness of using seraffix ltb system for soft tissue bonding.

dermatologic wounds can be closed by a variety of methods. the choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. the purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces. several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. there have been two fundamental approaches to laser assisted bonding of tissues: 1. laser welding-heating the approximated edges of cuts in tissues by a laser beam; 2. laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue). seraffix has developed the seraffix ltb (laser tissue bonding) system - a laser system for soft tissue bonding. this innovative system includes features that make laser soldering suitable for clinical use. the seraffix system is composed of co2 laser device, propriety grip device (clamps) and soldering agent (human albumin).

Eligibility criteria:
inclusion criteria: * male/female age 18-60. * subject is scheduled for laparoscopic cholecystectomy surgery. * subject able to comprehend and give informed consent for participation in this study. * signed informed consent form. exclusion criteria: * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening. * acute infection requiring intravenous antibiotics at the time of screening. * bleeding, coagulation and or clotting disorders. * diabetes mellitus: iddm or niddm. * hiv positive or any other immunosuppressive disorder. * renal failure (serum creatinine \>2.0 mg/dl). * inflammatory and or allergic diseases or condition of the skin: psoriasis, eczema or dermatitis. * any concomitant infection - viral or bacterial. * drug abuse. * use of steroids. * infection / abscess / pain in treatment target area. * pregnancy or lactating. * history of keloid scarring. * use of aspirin or antioxidants * subject is suffering extreme general weakness. * subject objects to the study protocol. * known cognitive or psychiatric disorder * concurrent participation in any other clinical study. * physician objection.

Keywords: laser bonding soft tissue albumin