Kornimate/medical-research-clean huggingface dataset:
oncologic outcomes of single-incision versus conventional laparoscopic surgery for colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: this study is designed to investigate long-term oncologic outcomes of single-incision laparoscopic surgery (sils) compared to conventional laparoscopic surgery (cls) for colorectal cancer.

in order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (sils) is attracting increasing attention. sils is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. in most previous studies, sils for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (cls) . however, there is still controversy over its potential better cosmetic effect and less postoperative pain. moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. up to now, most studies were limited to their retrospective nature and small samples. so more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for sils for colorectal cancer.

Eligibility criteria:
inclusion criteria: * 18 years \< age ≤85 years * tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection) * pathological or highly suspected colorectal carcinoma * clinically diagnosed ct1-4an0-2 m0 lesions according to the 8th edition of ajcc cancer staging manual * tumor size of 5 cm or less * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * body mass index (bmi) \>35 kg/m2 * the lower border of the tumor is located distal to the peritoneal reflection * familial adenomatous polyposis (fap) * inflammatory bowel disease (ibd) * multiple malignant colorectal tumors * pregnant woman or lactating woman * severe mental disease * previous gastrointestinal surgery (except appendectomy ） * emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer * requirement of simultaneous surgery for other disease * simultaneous or metachronous multiple cancers with disease-free survival ≤ 5 years

Keywords: single-incision laparoscopic surgery conventional laparoscopic surgery colorectal cancer
the effect of the caligaloc orthosis on standing and walking of hemiparetic patients with ankle varus

Conditions: Hemiparesis; Varus Deformity of Equine Carpus

Summary: to assess the benefit of an anti-varus ankle foot orthosis (caligaloc, bauerfeind) on gait and balance parameters in hemiparetic patients.


Eligibility criteria:
inclusion criteria: * hemiparesis at \> 3 months (whatever the etiology) * varus or equinovarus foot disturbing the stance phase of gait * able to walk at least 10m, with or without assistive device exclusion criteria: * unable to walk 10m * botulinum toxin injection less than 3 months before inclusion * history of neurological or locomotor pathology in addition to the etiology of hemiparesis * severe comprehension troubles * pregnancy

Keywords: stroke hemiplegia
effects of a recreational team handball-based programme on health and physical fitness of postmenopausal women

Conditions: Menopause

Summary: this study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport. the investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).


Eligibility criteria:
inclusion criteria: * inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years exclusion criteria: * any medical contraindications to perform moderate-to-vigorous physical activity
study to improve survival among hiv-exposed infants in botswana

Conditions: HIV Infections; Neutropenia; Anemia

Summary: the purpose of this study is to find ways to improve infant health and survival among infants whose mothers are hiv-infected but who do not themselves have hiv.

as improved mtct prevention interventions reduce the number of hiv-infected infants in the antepartum and peripartum periods, interventions to improve hiv-free survival among hiv-uninfected infants are needed. morbidity and mortality are increased among hiv-uninfected infants born to hiv-infected mothers, and reduced infant survival among hiv-exposed infants may lead to as many deaths as hiv infection itself. in botswana, the use of formula feeding or shorter breastfeeding may worsen the problem of early infant mortality among hiv-exposed infants. the study will enroll pregnant or postpartum hiv-1-infected women, and their hiv-uninfected infants in botswana. at 2-4 weeks of age, live hiv-uninfected infants will be randomized to receive either double-blinded cotrimoxazole (ctx) or placebo from 2-4 weeks through 15 months. in addition, breastfeeding (bf) infants will be randomized to bf until either 6 or 12 months of age. children will be followed prospectively until 18 months of age. the primary endpoint will be survival at 18 months comparing all infants in the ctx vs. placebo arms, and by randomized duration of bf among those bf at randomization. secondary endpoints will evaluate survival and morbidity/mortality at 12 and 15 months; hiv-free survival to 18 months; and the safety of ctx prophylaxis. secondary observational objectives include comparing mtct and mortality by initial feeding method (formula feeding or any bf \> 1 month), and an analysis of maternal characteristics as predictors for initial feeding choice and hiv-free survival. all women and infants will receive standard antenatal and peripartum prophylaxis from the botswana government for mtct prevention (pmtct), and will choose a feeding method with counseling. breastfeeding infants will receive infant nevirapine (nvp) prophylaxis or will be protected from mtct by the use of maternal haart.

Eligibility criteria:
inclusion criteria: * hiv-infected women, \> 26 weeks gestation and \< 34 days postpartum. * women must be ¬\> 18 years of age and willing/able to sign informed consent. * women and infants must be able to follow up regularly at a study clinic through 18 months postpartum. * for feeding randomization only: women must be willing to breastfeed for up to 12 months, and to stop at 6 months, depending upon their feeding assignment. exclusion criteria: * antepartum women: known infant anomalies resulting in a high probability that the infant will not survive to 18 months. * postpartum women: known hiv-infected infant, or infant medical condition making survival to 18 months unlikely.

Keywords: hiv trimethoprim-sulfamethoxazole combination breast feeding infant mortality morbidity botswana africa infectious disease transmission, vertical adverse drug event
multicomponent intervention in caregivers on quality of life of people with dementia: a clinical trial

Conditions: Alzheimer Disease; Caregivers; Quality of Life

Summary: the main objective is to determine the effectiveness of a multicomponent intervention for caregivers, conducted by an expert psychologist to improve the quality of life of the people with alzheimer's disease. secondarily, will be analyzed the effectiveness of this program on improving anxiety and depressive symptoms, burden, happiness, social support and cognitive performance of the caregivers and alleviate the behavioural and psychological symptoms of dementia (bpsd). the investigators analyze the caregiver's and patient's personality as a possible moderator between dependent and independent variables, and the resources utilization before and after intervention. methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. the eligible participants will be 94 adult (≥18 years) caregivers of patients with alzheimer's disease who follow-up by osona integrated geriatric unite (catalonia, spain). the intervention group will receive a multicomponent intervention that includes dementia psychoeducation and management, emotional and communication skills, mindfulness and healthy lifestyle. the control group will follow the standard management according to the primary and specialized care professionals' team. main measurements: quality of life of the patients at baseline, after intervention and at six-month follow-up through qol-ad. secondary measures: they will be determined, at baseline, after the intervention and at six-month follow-up: depression (hdrs) and anxiety (hars), burden (cbi), happiness (ohq), quality of life (qol-ad), social support (ucla and duke-anc), cognitive performance (neuropsychological assessment) of the caregivers, resources utilization (rud), bpsd (npi), cognitive status (mmse), functional status (iadl) of the patients. caregiver's personality at baseline and six-month follow-up and dementia characteristics at baseline will be measured. other measures: sociodemographic and health characteristics of the caregivers and patients.


Eligibility criteria:
inclusion criteria: * adults (≥18 years of age) * main caregivers of people with early or mild alzheimer's disease * follow-up by osona integrated geriatric unite (catalonia) * signed informed consent. exclusion criteria: * non stable medical condition the last six months (or any acute or chronic condition that would limit the ability of the patient to participate in the study) * cognitive impairment (mmse\<24) * substance abuse * active psychotherapy * refusal to give informed consent
the effects of perioperative nutritional optimization on blood markers

Conditions: Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

Summary: the purpose of this study is to see if taking an oral nutrition supplement (ensure nutrition shake) before and after lumbar spine surgery affects blood tests related the nutritional status of patients. patients with poor nutritional statuses who undergo elective lumbar spine surgery are at increased risk for complications and longer hospitalizations.

the study will examine whether a simple and cost-effective perioperative nutritional program will affect blood markers of nutritional status (albumin, pre-albumin, transferrin, electrolytes). all patients 55 years and older who are undergoing lumbar spine surgery at our institution by a single surgeon and meet all inclusion criteria will be added to this study. patients will be randomized into one of two arms; the interventional group will be provide with daily ensure protein drinks for two weeks pre-operatively and four weeks post-operatively, while the control group will be instructed to continue their current diet plans. four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin, electrolyes) will be obtained to assess objective differences in nutritional status. n/a

Eligibility criteria:
inclusion criteria: * patients aged 55 years and older undergoing primary lumbar spine surgery for the treatment of radiculopathy and other lumbar pathologies * patients have the willingness and ability to participate in a study procedure exclusion criteria: * patients who are younger than 55 years old * patients undergoing revision surgery * patients undergoing surgery due to trauma/fractures * patients with lactose intolerance
early dry cohort : impact on the fluid balance of a perfusion based protocol to adjust ufnet during deresuscitation in intensive care unit.

Conditions: Acute Kidney Injury

Summary: fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. if fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). in patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. a potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia. we have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. we would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.


Eligibility criteria:
inclusion criteria: * - age ≥ 18 ans * acute kidney injury with continuous renal replacement therapy * fluid overload \> 5% * equivalent norepinephrine dose \< 0,5 µg/kg/min exclusion criteria: * - chronic intermittent haemodialysis * active bleeding * stroke with coma * pregnancy * advanced directives to withhold or withdraw life-sustaining treatment * patient's opposition to the use of his/her personal health data."

Keywords: ultrafiltration deresuscitation fluid overload fluid balance.
effect of pranayama on periodontal health

Conditions: Chronic Periodontitis

Summary: the objective of the study was to evaluate the levels of peroxisome proliferator-activated receptor gamma (ppar-γ), nuclear factor-kappa b (nf-kb) and the presence of red complex microorganisms (rcm) such as treponema denticola (t.d), porphyromonas gingivalis (p.g) and tannerella forsythia (t.f) in the subgingival tissues of chronic periodontitis subjects before and after intervention with pranayama as an adjunct to scaling and root planing.

sixty chronic periodontitis subjects were selected out of which 30 subjects (control group) were treated with scaling and root planing (srp) and 30 subjects (pranayama group) also underwent srp and pranayama for 3 months. clinical parameters were recorded and the presence of ppar-γ, nf-kb and rcm were assessed at baseline and after 3 months

Eligibility criteria:
inclusion criteria: * presence of at least 20 teeth * probing pocket depth ≥ 5 mm exclusion criteria: * aggressive periodontitis * systemic disorders * pregnant \& lactating females * smokers \& alcoholics * immunocompromised individuals

Keywords: chronic periodontitis nuclear factor-kappa b pranayama peroxisome proliferator - activated receptor gamma red complex microorganisms
spelling mistake tolerant word prediction for working, writing and communicating

Conditions: Dysorthographia; Neurologic Disorder

Summary: the main objective of the predict4all project is to provide written communication in a computer, reducing the number of spelling errors for each user. the effectiveness of written communication is defined in this study by the number of spelling errors for each user. word prediction (and therefore correction) must be able to be configured by a therapist (speech therapist, occupational therapist). adapting the prediction to user errors should also allow it to be more relevant throughout the text input. this software efficiency must increase text input speed, reduce the cognitive load, establish a classification of spelling errors adapted to the context of text input speed and develop the word prediction module tolerant of these spelling errors.


Eligibility criteria:
inclusion criteria: * aged between 6 and 25 years old for center 1 * patient with dysorthographia * educational level greater than or equal to ce2 * a developmental level in reading on the evalouette test (evaleo battery) greater than or equal to ce1 for center 2 * neurologic disorder impacting communication exclusion criteria: * patient's refusal to participate in the study * persons under guardianship * pregnant women * no affiliation to a social security scheme (beneficiary or beneficiary) * having visual disturbances preventing the use of the computer tool

Keywords: word prediction dysorthographia
an open-label, non-randomized, single-arm study to investigate the mechanism(s) by which nevirapine increases plasma hdl in hiv+ subjects

Conditions: HIV Infections; Metabolism, Lipids

Summary: 1. in order to obtain further insight as to how nvp affects hdl metabolism, the in vivo kinetics of the hdl apolipoprotein, apo a-1, before and 6 weeks after initiation of nvp containing treatment were evaluated. in addition, the activity of the key enzymes related to hdl metabolism were assessed. \[ designated as safety issue: no \] 2. in order to determine the relevance of the hdl increase in decreasing cardiovascular risk in hiv-positive subjects we evaluated endothelial function (fmd) as a surrogate marker for cardiovascular disease in patients. \[ designated as safety issue: no \]


Eligibility criteria:
inclusion criteria: patients will be included when they meet the following criteria: 1. 18 years of age or older. 2. ability and willingness to provide signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation. 3. patients on stable therapy with trizivir only (or its equivalent component drugs), for at least 6 months prior to screening. 4. patients with plasma hiv-1-rna \<=50 copies/ml documented on at least two occasions within 6 months prior to enrollment. 5. documentation of plasma hiv-1 rna of \ =6 months while on trizivir without other antiretroviral agent. documentation will include dates and results of all viral load testing from the previous six months. 6. ability and willingness to complete the study. exclusion criteria: patients will not be included when they meet one or more of the following criteria: 1. previous exposure to nnrti drugs. 2. documented diabetes mellitus. 3. documented hypertension (systolic \>155 mmhg and/or diastolic \>95 mmhg). 4. fasting hypertriglyceridemia (\>5.6 mmol/l or 500 mg/dl). 5. use of lipid-lowering medication during the 90 days prior to study enrollment. 6. chronic active hepatitis b and/or c infection by history. 7. anemia (hb \<7.0 mmol/l or 11 g/dl hematocrit \<32%). 8. active opportunistic infection or neoplasm within 3 months prior to screening visit with the exception of cutaneous kaposi's sarcoma without evidence of progressive disease. 9. any history of cardiovascular disease (infarction, heart failure, peripheral vascular disease, cerebrovascular disease). 10. hepatic, renal or thyroid abnormalities, as determined significant by the principal investigator. 11. pregnancy or lactation. 12. active anticoagulation therapy (coumarin derivates, heparin). 13. history of hiv-2 infection. 14. female patients with cd4 counts \>250 cells/mm3. 15. male patients with cd4 counts \>400 cells/mm3. others which can not be listed here.
the prebiotic effect of daily intake of orange juice affects the bioavailability of flavanones?

Conditions: Intestinal Diseases

Summary: this study aimed investigate the chronic effect of orange juice consumption on gut microbiota and in the bioavailability of flavanones and metabolites by feces, blood and urine analysis.

non-randomized study with interrupted time series and open-label, in which women were enrolled and advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages during 30 days before of intervention (n=10; bmi 23.8 kg/m2; 28 years). after 30 days, the participants will consume during 60 days 300 ml of orange juice daily. after 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and in the bioavailability of its flavanones. the recruitment process began in september 2016 and the intervention was carried out from october 2016 to february 2017, and the data analysis will start in february 2017. the sample number took into account variances on blood hesperitin levels with a type i error α = 0.05 and a type ii error β = 0.2 (80% power) (silveira et al., 2015). the minimum sample size should have six individuals into the same group. considering an approximately 15% dropout rate, the final sample size of study was constituted by 10 women. primary endpoint is the changes in total bacteria population (lactobacillus spp., bifidobacterium spp., and reduction of clostridium spp.) that can result in increased of butyric, acetic, and propionic acid concentrations, and reduction of ammonium production. secondary endpoint is enhancement of bioavailability of flavanones (hesperitin, naringenin) and metabolites in the blood, urine and feces. kolmogorov smirnov and levene test will be used to assess the normality and homogeneity of data, respectively. one-way analysis of variance (anova) will be apply to determine the intervention effect over the time 0, 30 day, 60 day, 90 day, and 120 day). p significance was set up ≤ 0.05.

Eligibility criteria:
inclusion criteria: healthy women bmi 18.5 - 29.9 kg/m2. exclusion criteria: gastrointestinal diseases pregnant women regular use of medications dietary restrictions, vegetarian diet, macrobiotic, etc. use of vitamins or dietary supplements use of probiotics or prebiotics in the last 3 months and antibiotics in the last 6 months.

Keywords: orange juice microbiota prebiotic flavanones bioavailability
near-infrared spectroscopy (nirs) for intracranial hematoma detection

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury is a common neurosurgical emergency managed in all tertiary and secondary hospitals. detecting the underlying pathology is a major challenge especially for surgical cases. the outcome differs if the early intervention is performed. near-infrared spectroscopy (nirs) based device will detect the hematoma at the bedside. it is not the replacement of a ct scan but can help in triage. this is a large-scale prospective study to establish the role of nirs device in detecting intracerebral hematoma and correlate the finding with ct scan finding.

the light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to penetrate the human tissue 'optical window'. once the light has penetrated into the tissue, it is either scattered or absorbed. light is mostly scattered by bones, skin and cerebral white matter. however, red blood cells, which represent roughly have a low scattering effect and high absorption. utilising this principle, the emitter and detector could be used to measure the light scattered by the tissues. the 'optical density' of the tissue is calculated and by comparing the left and right hemispheres in the eight contralateral locations of the brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. a nirs device named cerebo® was developed by bioscan research, ahmedabad, india. it is a low power non risky device that can screen the patient's head multiple times without causing any side effect. the built in safety features in cerebo® make it fail safe system for intentional as well as accidental exposure to laser beam. the average power and total power dissipation is very low. the system poses no risk to the patients who will be included in the study. so far the overall results of detection rate of hematoma using nirs device are contradictory. it is not the replacement of a ct scan but can help in triage. in the present research the investigators plan to do a large scale prospective study to establish the role of nirs device in detecting intracerebral hematoma and correlate the finding with ct scan findings.

Eligibility criteria:
inclusion criteria: * acute traumatic brain injury patients reaching the hospital exclusion criteria: * major scalp laceration or active bleeding. * significant extracranial hematoma.

Keywords: traumatic brain injury traumatic intracranial hematoma extradural hematoma subdural hematoma cerebral contusion near-infrared spectroscopy