Kornimate/medical-research-clean huggingface dataset:
effect of family member's massage therapy on the vital signs and glasgow coma scale score

Conditions: Trauma

Summary: the effect of family member's massage therapy on the vital signs and glasgow coma scale score of hospitalized patients in intensive care unit: a triple-blinded randomized controlled clinical trial study

aims and objectives: to determine the effects of family member's massage therapy on the vital signs and glasgow coma scale score of hospitalized patients in intensive care unit. background: unalleviated complications related to hospitalization including stress, anxiety, pain, and fear can easily impacts on different systems including brain and stimulates sympatric nerves and as a result causes instabilities in vital signs and deterioration in consciousness level. alternative and complementary therapies including therapeutic massage have been used to decrease the mentioned side effects. design: a triple-blinded randomized controlled clinical trial methods: all prolonged hospitalized patients and their families (45 patients and 45 family members in each group) were selected consecutively among the patients admitted in icu. data collection tool consisted of two parts. the first part included demographic data (age, mar¬ital status and body max index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse rate). all measurements were conducted in same time in both groups as follow: before the intervention (the whole massage therapy), one hour, two hours, three hours, and four hours. collected data was analyzed using descriptive and analytical statistics utilizing spss 11.5 software. keywords: family member's massage therapy; vital signs; glasgow coma scale; intensive care unit; randomized controlled clinical trial; iran.

Eligibility criteria:
inclusion criteria: * more than 10-day hospitalization, hemodynamic stability, having the glasgow coma scale score between 7 to 12, intra cranial pressure less than 20 mmhg, no limitation or contraindication for changing in body position (including active bleeding or flail chest) and body massage (such as advanced burn degrees, severe dyspnea, fever, etc) and willing to participate in the study exclusion criteria: * any factors which violate inclusion criteria

Keywords: family member's massage therapy vital signs glasgow coma scale intensive care unit randomized controlled clinical trial iran
cognitive function in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the study is to investigate the relationship between cognitive function, functional capacity, cognitive reserve and reaction time in patients with multiple sclerosis.

cognitive impairment in patients with ms is a common problem that significantly affects quality of life. it shows an association between functional capacity and physical fitness levels and cognition in non-ms populations, and especially in the elderly. although cognitive dysfunctions are known, few studies have been found on its relationship with secondary problems caused by the disease and its correlation with other symptoms.

Eligibility criteria:
inclusion criteria: * relapsing-remitting ms diagnosis * expanded disability status scale score \<5.5 * being able to use a smart phone * no relapse during the last 30 days * being between the ages of 18-65 * mini-mental state examination score\>24 exclusion criteria: * severe visual impairment * severe psychiatric disorder, * severe arthritis in knee or hip, * pregnancy and other neurological or vestibular disorders that may prevent the patient from completing the functional examination

Keywords: multiple sclerosis cognitive function cognitive reserve functional capacity
study to assess the efficacy and safety of azd1981 in patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Moderate to Severe COPD

Summary: the purpose of this study is to study efficacy and safety of azd1981 in patients with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * fev1 between 30 and 80% of predicted normal value post-bronchodilator (gold stages 2 and 3) * clinical diagnosis of copd exclusion criteria: * other clinically relevant disease or disorders * exacerbation of copd within 30 days

Keywords: copd
interventional study to evaluate the effect of the oral administration of l.plantarum on vaginal microbiota

Conditions: Vaginal Infection

Summary: vaginal microbiota is abundantly colonized by lactobacillus genera. when vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis. probiotics are living organisms that provide the host certain benefits. despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some lactobacillus strains in vaginal microbiota. the lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal candidiasis in women with high vaginal candidiasis prevalence. nowadays the lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. because of that, this study aims to determine whether this lactobacillus strain is able to colonize vaginal microbiota when administered orally.


Eligibility criteria:
inclusion criteria: * asymptomatic subjects with vaginal microbiota classified as lbg (lactobacillary grade) i, iia or iib. * using the same contraceptive within 4 weeks prior to study start. exclusion criteria: * current vaginal infection. * vaginal infection 1 month prior to study start. * cervico-vaginal pathology. * papilloma human virus. * pregnant or breastfeeding mothers. * using iud. * immunomodulators or systemic corticoids intake. * vaginal or systemic antibiotics intake 1 month prior to study start. * vaginal probiotic intake 1 month prior to study start. * less than three months after giving birth or abortion. * undergone vaginal or intestinal surgery three months prior to study start. * severe stress or depression. * systemic acute or severe disease. * history of alcohol or drug abuse. * chronic intestinal pathology. * not understanding protocol procedures. * use of lubricant 24 hours or spermicide 7 days prior to study start. * swallowing difficulties. * impossibility to understand study procedures. * enrolled in another clinical study. * atrophic vaginitis not under treatment

Keywords: vaginal probiotic
observational study using the cova monitoring system 3

Conditions: Healthy

Summary: asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. it is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. these symptoms are particularly prevalent at night-time. understanding and tracking these symptoms can lead to better management of asthma. auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night. the aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the cova patch.


Eligibility criteria:
inclusion criteria: * participant is between the ages of 4 - 17 years old at the time of consent * participant and/or family member/carer willing to give written consent * participant and/or family member/carer who can read and comprehend english exclusion criteria: * subject believed to be unsuitable for inclusion by the principle investigator * subject is pregnant at time of consent * subject is currently enrolled in another medical study

Keywords: healthy volunteers
association of macular pigment optical density (mpod) and genetic variants in complement factor h in subjects with choroidal neovascular (cnv)

Conditions: Age-related Macular Degeneration; Choroidal Neovascular Age-related Macular Degeneration

Summary: subjects with wet amd, dry amd, and age-matched controls will undergo routine occular measurements, will provide a blood and cheek cell sample, and will have macular pigment optical density (mpod) measured to determine if there is an association between genetics, mpod and the risk of progression to wet amd.


Eligibility criteria:
inclusion criteria: * subject is diagnosed with either cnv, dry amd or is an age-matched control * self reported as non-hispanic caucasian * 60 years of age or older * provides signed and dated informed consent * agrees to provide 10 ml of whole blood and two buccal swabs exclusion criteria: * previous donation under this protocol

Keywords: age-related macular degeneration choroidal neovascular age-related macular degeneration genetics macular pigment optical density (mpod)
optimal tube feeding method in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to assess the optimal tube feeding method (bolus, gravity or pump) by analyzing percent weight loss, tolerance of enteral feeds, and percent of estimated calorie and protein needs in 60 patients with squamous cell carcinoma of the head and neck undergoing chemoradiation therapy.

it is a great challenge to maintain the nutritional status of the head and neck cancer (hnc) patients through treatment advances such as combined chemoradiation therapy or crt. for all these reasons, hnc patients undergoing treatment, frequently require alternate methods of nutrition support such as as enteral tube feeding via a gastrostomy tube.upon gastric tube feeding initiation, the registered dietitian (rd) must consider the three different methods: bolus (using a syringe), gravity (using gravity feeding bags), and pump (using a tube feeding pump). typically, patients are started on bolus (option a), changed to gravity (option b) if bolus feeds are not tolerated, and ultimately changed to pump (option c) if gravity feeds are not tolerated. the concern is that in this process of starting with option a, and moving to option b or further to option c, the patient may experience unintentional weight loss and dehydration related to tube feeding intolerance and/or tube feeding inadequacy. consequently, this places the patient at risk of, but not limited to, hospital admission for dehydration and/or malnutrition, and treatment interruption. therefore, exploring the idea of an optimal feeding method and starting patients on it from the beginning, may improve patient outcomes in terms of nutritional status.

Eligibility criteria:
inclusion criteria: * males and females * 18 years or older * diagnosis of scchn undergoing concurrent chemoradiation therapy (including patients who received induction therapy upfront exclusion criteria: * patients who have a small bowel feeding tube (only tube feeding via pump is allowed in this case) * patients with history of gastric surgery which may have resulted in altered gastrointestinal function * patients with history of uncontrolled diabetes and/or gastroparesis which may interfere with gastric emptying and inability to tolerate bolus feeds * patients at high risk of aspiration in which case slower feeds by using gravity or pump are indicated

Keywords: head and neck cancer chemoradiation therapy bolus feeding gravity feeding pump feeding optimal enteral feeding method to determine the optimal tube feeding method by analyzing percent weigtht loss. to determine the optimal tube feeding method by analyzing tolerance of enteral feeds. to determine the optimal tube feeding method by analyzing percent met of estimated calories and protein.
randomized double-blind trial of midazolam and loxapine in agitated patients

Conditions: Acute Agitated Patients

Summary: neuroleptics are used since a long time in the management of severely agitated patients. loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. however, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. the aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

prospective, randomized, double-blind, multicenter study (20 french emergency departments)

Eligibility criteria:
inclusion criteria: severely agitated patients (richard scale over or equal to 5) between 18 and 65 years old exclusion criteria: hypoglycemia hypoxemia patients with known dementia blood pressure \<90 mmhg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital

Keywords: sedation midazolam loxapine agitation emergency department toxicological analysis
does the length of hospital stay for rehabilitation affect functional outcomes in stroke patients

Conditions: Stroke

Summary: the purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients.

the medical records of patients who were admitted to a rehabilitation unit were analyzed retrospectively. the functional output, the level of spasticity, and the level of motor development at admission and discharge will be determined using the functional independence measure instrument, the modified ashworth scale, and the brunnstrom test, respectively. based on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3 months (group 1) and \> 3 months (group 2). clinical features and functional output will be compared between the groups.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke * must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013 exclusion criteria: * previous history of stroke, * other neurological diseases, * amputation, * severe arthritis * undergoing hemodialysis

Keywords: neurological rehabilitation stroke rehabilitation outcome
effectiveness and safety of oral anticoagulants among obese patients with non-valvular a-fib in va patients with medicare

Conditions: Atrial Fibrillation; Obesity; Anticoagulants

Summary: the overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (nvaf) who initiate therapy with oacs (oral anti-coagulants). the aim of this study is to compare all doacs (direct oral anti-coagulants) to warfarin. however, the primary analysis will be conducted among apixaban vs warfarin patients only. if sample size permits, we will also conduct other doac vs warfarin and doac vs doac analysis.


Eligibility criteria:
inclusion criteria: * obese or severely obese. * initiated an oac from july 1, 2013 - december 31, 2017; the first doac pharmacy claim date during the identification period will be designated as the index date. the first warfarin prescription date will be designated as the index date for patients without any doac claim. * individuals ≥18 years old as of the index date. * had 6 months continuous health plan enrollment with medical benefits (parts a \& b) for at least 6 months pre-index date (baseline period). * at least 1 diagnosis of af prior to or on index date, identified by any medical claim associated with an international classification of diseases, ninth revision, clinical modification (icd-9-cm) code of 427.31 or international classification of diseases, tenth revision, clinical modification (icd-10-cm) code of i480-i482, and i4891. * had body weight or bmi value reported within ±6 months of the index date. exclusion criteria: * had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient af 6 months prior to or on the index date. * had hip/knee replacement surgery within 6 weeks prior to or on the index date. * were pregnant during the study period. * had an oac prescription during the 6 months pre-index date. * had follow-up time equal to 0 days. * had more than one oac on the index date.

Keywords: medicare veterans affairs major bleeding stroke
comparison of rvot gradient under anaesthesia with post-operative gradient in patients undergoing tof repair

Conditions: Tetralogy of Fallot

Summary: the primary objective of the study will be to compare intraoperative post tof repair rvot gradient under two different anaesthetic depths. secondary objectives will be to follow up change in rvot gradient till 1 month post-operatively, observe extubation time, inotropes used post-operatively by vasoactive- inotropic score (vis), rv functions at discharge from icu and at 1 month follow- up

after completion of the tof repair and rewarming to normothermia, all the patients will be assessed by tee for adequacy of repair and separated from the cardiopulmonary bypass using vasopressors and inotropes. the choice of vasoactive and inotropic agents will be as per the requirement to maintain stable hemodynamics of the patients. post bypass sevoflurane 1% end tidal concentration (0.5 mac) will be used in all the patients. rv pressure and gradients across rvot will be measured directly by placing a 23 gauge needle into the rv and pulmonary artery, and also by tee using bernoulli's equation by placing continuous doppler across tricuspid regurgitation jet and rvot, as is being routinely done for patients undergoing tof repair. in addition, velocity time integral (vti) across left ventricular outflow tract (lvot) will also be recorded along with other hemodynamic parameters such as hr, sbp, dbp, map and spo2. subsequently, these measurements will be repeated again after increasing the sevoflurane to 2% end tidal concentration (1 mac) and allowing the patients to stabilise on this new concentration for 5 minutes while maintaining systemic pressure within a range of 5% of the previous value. normocarbia (etco2 30-35 mmhg) will be maintained during these measurements by adequate minute ventilation. following the surgery, all the patients will be shifted to cardio-surgical icu and will be extubated once they meet the extubation criteria. post-operative rvot pressure gradient and rv functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at discharge from icu and after 1 month of surgery on first follow-up. rv functions on echocardiography will be assessed using tapse (tricuspid annular plane systolic excursion) and fractional rv area change during systole. the duration of post-operative mechanical ventilation, vasoactive inotropic score (vis), pao2/fio2 ratio till discharge from icu and any morbidity or adverse outcome during hospital stay will be noted.

Eligibility criteria:
inclusion criteria: * all the children between 6 months to 16 years of age undergoing tof repair will be included in the study. exclusion criteria: * tof patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.
trial of therapeutic vaccine in patients with cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: cholangiocarcinoma (cca) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. it is the second-most common liver cancer, after hepatocellular carcinoma (hcc). about 6,000 people in the united states develop bile duct cancer each year. one-year survival is less than 25% and no effective and safe systemic treatments are currently available. last year the completion of open-label phase 2 trial (nct02256514) of hepcortespenlisimut-l (v5) has been reported, which has shown that two-third of mongolian patients with advanced hcc had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. so far a few patients with cca were treated with v5, but it appeared that their response rate was somewhat inferior to patients with hcc since two (both with hemochromatosis) out six patients died within 6 months. in one patient who had improved clinically, the improvement was correlated with decrease in ca19-9 tumor marker, but no marker profile information is available in regard to other cca patients. as v5 tablets are made from pooled blood of patients with hcc, in theory, they will be not very useful to patients with cca. the goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with cca and initiate pilot open-label trial in 20 cholangiocarcinoma patients. this clinical trial will be conducted in collaboration with the national cancer center.

upon obtaining regulatory and ethical approvals the phase ii single-arm study will be initiated at the ncc involving 20 patients with confirmed cca diagnosis. the trial will be short, it will last only 2 months, but this will be sufficient to gauge the safety and efficacy. only those patients who have higher than normal levels of ca19-9 tumor marker will be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (afp) has been used as a predictor of clinical response in hcc patients. additional primary endpoints will be overall survival and changes in tumor burden, with secondary endpoints being liver function tests and changes in quality of life.

Eligibility criteria:
inclusion criteria: * only those positive for ca19.9 exclusion criteria: * pregnant and lactating females
the effects of jeju steaming onion(oniro) on reducing body fat of overweight or obesity subjects

Conditions: Overweight; Diabetes Mellitus; Obesity

Summary: it is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (tg) and total cholesterol (tc). in this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects.

a randomized, double-blind, placebo-controlled clinical trial was conducted to verify the effects of jeju steam onion. fifty-six healthy male and female subjects aged 20-65 years with normal body weight \[25.0 kg/㎡ ≤ body mass index (bmi) \< 30.0 kg/㎡\] were recruited. the basic framework of the present study was based on a previous study. a 12-week (at each visit; screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with overweight subjects (25.0 kg/㎡ ≤ bmi \< 30 kg/㎡). subjects participants were divided into two group: either jeju steaming onion or matching placebo (the baked barley powder). randomization was achieved by computer generated block randomization (placebo : test = 1 : 1).

Eligibility criteria:
inclusion criteria: overweight(who) subjects \[25.0 kg/㎡ ≤ body mass index (bmi) \< 30 kg/㎡\] exclusion criteria: * uncontrolled blood pressure (blood pressure level more than 140/100mmhg) * fasting blood sugar level more than 126 mg/dl or taking medications (including blood sugar and anti-diabetic drugs) * history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease * taking a weight change medications within 1 month before study * participation other obese studies within 2 months before study * having a known allergy to any ingredient in the investigational product * participation other intervention studies within 1 months before study * women who are pregnant or desire to become pregnant during the study period * having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study

Keywords: overweight body fat diabetic, obersity diabetes mellitus dm glycemic