Kornimate/medical-research-clean huggingface dataset:
pilot study of strepic® device for the diagnosis of group a streptococcal pharyngitis

Conditions: Group A Streptococcal Infection

Summary: the objective of this pilot study is to acquire images using the strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. by acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with group a streptococcus (gas)-associated pharyngitis and comparing them with those observed in non-gas pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify gas infections.


Eligibility criteria:
inclusion criteria: 1. all patients aged 7-64 years of age with suspected gas pharyngitis with modified centor (mcisaac) score ≥2; and 2. patient agrees to participate in study and patient or parent/guardian sign consent/assent form. exclusion criteria: 1. pharyngeal swab performed immediately prior to study team approach; 2. prior enrollment in this study; 3. pharyngeal symptoms \>7 days; 4. peritonsillar abscess; 5. antibiotic use within one week of index visit; 6. inability to open mouth to visualize the pharynx; and 7. inability to understand english or spanish, as study forms including consent and assent forms will be written in english and spanish; 8. woman who is pregnant (self-reported, pregnancy test will not be performed) or nursing; 9. current prisoner (define as an individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution).
the effect of mouthrinses containing bamboo salt, magnolia bark and centella asiatica on reducing plaque and gingivitis

Conditions: Gingivitis; Dental Plaque

Summary: this study aims to evaluate the effect of novel mouthrinse formulations containing bamboo salt, magnolia bark and centella asiatica extracts on gingivitis and dental plaque. participants uses mouthrinses which contain bamboo salt, magnolia bark and centella asiatica extracts and the same participants will also use placebo for tooth brushing by cross-over design.

this is a randomized clinical intervention study with a cross-over design. the subjects are randomly allocated to one of the three experimental groups: 1) the control; 2) asm group for aqueous single-phase mouthrinse; 3) otm group for oil-water two-phase mouthrinse. the experimental mouthrinses all contain sodium fluoride and the asm and otm contain additional ingredients of bamboo salt, magnolia bark and centella asiatica extracts. for the otm, 50% essential oil is added to create an oil-water two-phase mouthrinse. subjects are instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. the completion of each experiment regimen is followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen.

Eligibility criteria:
inclusion criteria: * healthy adults with at least 20 natural permanent teeth * mild to moderate plaque (≥20% o'leary index) * mild gingivitis (20-30% bop rate). exclusion criteria: * individuals undergoing orthodontic treatment * individuals having deep periodontal pockets (≥ 6mm at two or more teeth) on more than two teeth * diabetics * pregnant or lactating women * individuals taking antibiotics within the past one month * individuals who have used any mouthwashes for the past 6 months.

Keywords: centella asiatica bamboo salt magnolia bark gingivitis dental plaque mouthrinse
prospective robotic-guided registry of spine surgery

Conditions: Spinal Disease

Summary: this study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

what is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? this will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. the primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries. it is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature. the secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. to this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Eligibility criteria:
inclusion criteria: * any pediatric, adolescent or adult patient * undergoing open or mis robotic-guided spine surgery using the mazor core technology. exclusion criteria: * pregnancy * active infection * malignancy * primary abnormalities of bone * primary muscle diseases (e.g., muscular dystrophy) * neurologic diseases * spinal cord abnormalities/lesions * paraplegia.

Keywords: robotic-guided spine surgery
cold snare endoscopic mucosal resection (c-emr) versus hot snare endoscopic mucosal resection (h-emr) for large colorectal polyps (10-20 mm)

Conditions: Polyps of Colon; Polyps; Polyp Intestine

Summary: objectives the aim of the study is to compare the efficacy of cold snare emr versus hot snare emr for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events. design : a randomised interventional study. sample size: 330

* this procedure will be performed by endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation. * in both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in cold endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by endocut q mode (ensures safe and effective removal of large lesions in particular large polyps) in hot endoscopic mucosal resection group. * after polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using nbi (narrow band imaging) and if present, will be cut off. * a standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps

Eligibility criteria:
inclusion criteria: * adult above 18 years * polyp size greater than 5-10mm. exclusion criteria: * inflammatory bowel disease * familial polyposis syndromes * patient who is unable to understand study protocol or not consenting * severe coagulopathy (inr greater than 1.5 platelets) * receiving antiplatelets withing 5 days of procedure * if antiplatelets stopped for 5 days-they were restarted on next day after procedure.
measuring fear of physical activity in patients with heart failure

Conditions: Chronic Heart Failure; Fear of Physical Activity

Summary: the study's aims are twofold: first, to examine physiological correlates of fear of physical activity (pa) and second, to examine correlates between fear of pa and interoceptive abilities in patients with chronic heart failure and healthy persons. patients' fear of pa will be assessed via the "fear of activity in situations - heart failure" (facts-hf) questionnaire. the patient group will be split into two subgroups: one with high fear of pa and the second with low fear of pa based on facts-hf scores. fear of pa will be assessed via an adapted version of facts-hf in a sample of healthy persons (control group). each member of the high-fear-of-pa group will be individually age- and sex-matched with one member of the low-fear-of-pa group and control group. the participants of all three groups undergo the same experimental trials. aim 1: the "startle paradigm" will be used to investigate the physiological component of fear of pa. the startle paradigm is based on empirical observations that the startle reflex is larger after the priming with unpleasant stimuli and inhibited after the priming with pleasant stimuli. the participants will be primed with various words including those words associated with physical activity that are expected to be unpleasant in patients with high fear of pa. the startle reflex will be triggered by air puffs on the eyes (startle probes) and measured via facial electromyography (emg). we assume that startle responses primed with pa related words are stronger in patients with high fear of pa compared to the other groups. aim 2: interoceptive accuracy will be assessed via the "schandry test" and interoceptive awareness will be assessed via the "multidimensional assessment of interoceptive awareness" (maia) questionnaire. during the schandry test the participants will be instructed to subjectively count their heart rate without any aid or tools. the heart rate will be objectively measured at the same time via ecg. a high congruence of the objective and subjective results indicates a high interoception ability, and is assumed to be correlated with fear of physical activity. additionally, we expect the maia and facts scores to be correlated.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure stage b or c (hunt et al., 2005), or: new york heart failure classification ii to iiib 1. systolic dysfunction: left ventricular ejection fraction \< 45% in the last 6 month 2. diastolic dysfunction: left ventricular ejection fraction \>= 45% in the last 6 month exclusion criteria: * complex ventricular arrhythmias * acute myocarditis * symptomatic cardiac valve stenosis * instable angina pectoris * other severe diseases, that impair physical activity (e.g. advanced stages of cancer) * insufficient language skills in german to answer the questionnaires * insufficient cognitive skills to answer the questionnaires
cortisol measurement during intravenous access with a medical clown

Conditions: Stress, Physiological

Summary: the purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. the investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (cortisol) in the blood.


Eligibility criteria:
inclusion criteria: * patients needing venous blood sampling or insertion of an intravenous canula * normal development according to parents exclusion criteria: * critically ill children (e.g. shock, respiratory distress or failure) * children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections) * known adrenal or pituitary disease * children who have received glucocorticoids during the preceeding six weeks

Keywords: medical clown pediatric emergency medicine
effect of therapy with aminoacid based formula versus hydrolyzed whey proteins in children with cow's milk allergy

Conditions: Cow's Milk Allergy

Summary: cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. in industrialized countries there is an incidence of 2-3% in children younger than 2 years. cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. it was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family. the treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction. there are some types of formulas for the treatment of this condition. the formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. being made from amino acids such formulas are by definition non-allergenic. they have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. however, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. to date thus lack consistent data on the nutritional effects in the medium to long term.


Eligibility criteria:
inclusion criteria: * subjects with diagnosis of cow's milk allergy exclusion criteria: * age \<5 months * age \>12 months * other concomitant chronic diseases * malformations * other food allergies
yoga: effect on attention in aging & multiple sclerosis

Conditions: Multiple Sclerosis

Summary: changes in visual attention are common among elders and people with multiple sclerosis. the visual attention changes contribute to difficulty with day to day functioning including falls, driving and even finding one's keys on the kitchen counter as well as contributing to deficits in other cognitive domains. yoga emphasizes the ability to focus attention and there is some evidence that the practice of yoga may improve one's cognitive abilities. additionally, yoga practice may improve cognitive function through other non-specific means such as improved mood, decreased stress or declines in oxidative injury. we propose a randomized, controlled 6 month phase ii trial of yoga in two separate cohorts: healthy elders and subjects with mild multiple sclerosis. we will determine if yoga intervention produces improvements on a broad attentional battery that especially emphasizes attentional control. to further understand the reported beneficial effect of yoga on its practitioners, we will also determine if there is a positive impact on measures directly related to yoga practice (flexibility and balance) as well as mood, quality of life and oxidative injury markers. the yoga intervention consists of a hatha yoga class meeting twice per week. the class is taught by experienced yoga teachers who are supervised by a nationally known yoga instructor. there are two control groups. an exercise group will have a structured walking program prescribed by a certified health and fitness instructor and personal trainer. the program will attempt to match the hatha yoga class for metabolic demand. the second control group will be assigned to a 6 month waiting list. the outcome measures are assessed at baseline and after the 6 month period. the primary outcome measures are alertness (quantitative eeg and self-rated scale), ability to focus attention (stroop) and ability to shift attention (extradimensional set shifting task). secondary attention outcome measures include the ability to sustain attention (decrement in reaction time) and ability to divide attention (useful field of view). other secondary outcome measures include flexibility, balance, mood, quality of life, fatigue (in ms cohort) and decreased markers of lipid, protein, and dna oxidative injury.


Eligibility criteria:
inclusion criteria: * patients with ms who are mildly impaired with an expanded disability status scale of 0-4.0 * healthy volunteers

Keywords: multiple sclerosis yoga
beyond weight loss maintenance study

Conditions: Obesity

Summary: a study to determine the effectiveness of two weight loss maintenance interventions in counterweight plus, a structured weight management programme.

introduction: long-term maintenance of non-surgical weight loss remains the most significant problem in obesity treatment. this study will compare the effectiveness of two different weight loss maintenance strategies used as part of the counterweight plus weight management programme. this study will also evaluate the behavioural impact of the counterweight plus interventions and include process evaluations and cost analysis. methods: 80 patients and 10 practitioners will be recruited into the study. main inclusion criteria for patients are: completed counterweight plus, which includes 12-20 weeks total diet replacement (tdr), 8 weeks food reintroduction (fr) and achieved \>10kg weight loss. all participants will be followed up for 18 months in total. results: the primary outcome of this study is the difference in weight change between the two groups at 6 months. frequency of use of behavioural strategy will be quantified for both practitioners and patients during voice recorded consultations. the relationship between weight change and the use of behavioural strategy will be assessed. hypothesis: this study will establish if the novel intermittent use of formula diet strategy is more effective at preventing weight regain in comparison to usual care. it will also provide evidence of the frequency of use of behavioural strategies within routine counterweight plus delivery, as well as establishing the cost of the intervention.

Eligibility criteria:
inclusion criteria: * completed counterweight plus total diet replacement and food reintroduction stages and achieved \>10kg weight loss exclusion criteria: * people currently participating in another clinical research trial (not including beyond weight loss study)

Keywords: weight loss maintenance
a trial to evaluate the safety and preliminary efficacy of imesenchymal stromal cells(imsc) in subjects with sr-agvhd

Conditions: Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)

Summary: a study to evaluate the safety and preliminary efficacy of imsc in subjects with sr-agvhd

a single center, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of imsc in subjects with sr-agvhd

Eligibility criteria:
inclusion criteria: 1.subjects who understand and voluntarily sign the informed consent form(icf); 2.4-70 years; 3.subjects with sr-agvhd; 4.ecog≤2; 5.subjects with ii to iv grades of steroid hormone resistance; exclusion criteria: 1. accepted systemic or local treatment of mesenchymal stem cells; 2. have severe allergy to blood products or have allergy history of heterologous protein; 3. expected survival period within 3 months; 4. alanine transaminase(alt)or aspartate aminotransferase(ast)\>2\*upper limit of normal(uln);creatinine clearance rate≤30ml/min or blood urea nitrogen(bun)\>2\*upper limit of normal(uln), international normalized ratio (inr)\>1.5\*upper limit of normal(uln); 5. have severe hepatic veno-occlusive disease(hvod); 6. have severe lung disease like severe lung infection; 7. have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure; 8. proved having resistant hypertension within 6 months before enrollment; 9. have active thrombus; 10. have untreated or uncertain active solid tumors within 5 years; 11. have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; 12. human immunodeficiency virus(hiv)antibody positive, treponema pallidum (tp) antibody positive; 13. have active hepatitis b or hepatitis c; 14. have gastrointestinal symptoms which not caused by gvhd 15. pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study; 16. subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening; 17. not suitable for this clinical trial for other reasons.
optimization for the treatment of advanced pulmonary large cell neuroendocrine carcinoma

Conditions: Pulmonary Large Cell Neuroendocrine Carcinoma

Summary: the primary endpoint is to compare the pfs (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.

the primary endpoint is to compare the pfs (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma. in addition, gene spectrum detection and mini-pdx are applied for validation of pharmacodynamic. results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for lcnec.

Eligibility criteria:
inclusion criteria: * stage iiib or iv pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology * estimated life expectancy over 3 months * performance status 0,1,2 * signed informed consent * adequate organ functions: absolute neutrophil count (anc) over 1,500 cells/mm3 (1.5 x 109/l); platelet count over100,000/mm3 (100 x 109/l); serum creatinine \< 2.5 mg/dl (221 mmol/l); serum ast or alt \<5.0 x upper limit of normal (uln); serum total bilirubin \<2.0 mg/dl (34 mmol/l) exclusion criteria: * history of chemotherapy or molecular targeted therapy * thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy * use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy * prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * pregnant or lactating * patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study

Keywords: pulmonary large cell neuroendocrine carcinoma,chemotherapy