Kornimate/medical-research-clean huggingface dataset:
efficacy of a probiotic lozenge (inersan) in patients with chronic periodontitis

Conditions: Chronic Periodontitis

Summary: periodontal disease is a major cause of tooth loss in humans and is one of the most prevalent diseases associated with bone loss. following bacterial colonization, the gingiva becomes inflamed leading, in some cases, to the destruction of the alveolar bone. periodontitis has two distinct but interconnected etiologic components, periodontopathic bacteria and host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. a few studies have revealed that probiotic lactobacillus strains were useful in reducing gingival inflammation and the number of black-pigmented rods, including porphyromonas gingivalis (pg), in the saliva and sub-gingival plaque. concerning periodontal conditions, its shown that application of beneficial bacteria, as an adjunct to scaling and root planing (srp), can inhibit re-colonization of pathogens in periodontal pockets and reduce bleeding on probing. the aim of the present study is to evaluate the improvement of periodontal health with probiotic (inersan) lozenges, used as an adjunct to scaling and root planing \[srp\].


Eligibility criteria:
inclusion criteria: * subjects of both sexes * patients in the age group of 25-60 years * subjects with mild to moderate chronic periodontitis, as defined by probing pocket depths 5-7mm in \> 30 % of the probing sites * the subjects should have at least 16 remaining natural teeth (minimum of at least 4 teeth per quadrant) * subjects in good general health exclusion criteria: * no antibiotic therapy in the past 2 months * medically compromised patients * subjects who are pregnant/ lactating * smokers and/or alcoholics. * those who had undergone any dental surgical or non-surgical therapy within 6 months prior to the start of the study.
dynamic heart failure prediction with real-time functional status data in the ambulatory setting

Conditions: Heart Failure

Summary: heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. this project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. the goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.


Eligibility criteria:
inclusion criteria: * hospitalized for decompensated heart failure * age \>=18 years * owns a smart phone * willing to measure self assess 6 minute walk test weekly exclusion criteria: * none
delayed umbilical cord clamping - c-section pilot

Conditions: Cesarean Sections

Summary: this is a pilot study of delayed cord clamping (dcc) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants. the investigators hypothesize that the pilot trial of dcc in cesarean sections will demonstrate safety of this procedure for mothers and babies.

despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. the world health organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. recently, the american college of obstetrics and gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research". the objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. we will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. we anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. if intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.

Eligibility criteria:
inclusion criteria:subjects that are pregnant (women 18 years of age and older) and scheduled for an elective c-section at ≥ 37 weeks gestation will be eligible for the study. exclusion criteria: pregnant women that do not plan on having a c-section and individuals that are not pregnant. pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. adults unable to consent will not be included

Keywords: umbilical cord cesarean section blood loss, surgical
protective effect of statin on sleep deprivation

Conditions: Sleep Deprivation

Summary: this study aimed to investigate the effect of 48-h sleep deprivation on heart rate variability (hrv) in young healthy people and the protective effect of statin on arrhythmia and hrv.

in the setting of earthquakes, floods, or fire disasters, rescue workers usually carry out their work without sleep. sleep deprivation (sd), which is a strong stressor, can exert a large effect on the cardiovascular system of rescue workers. it has been reported that sd is associated with arrhythmia, dyslipidemia and type 2 diabetes. heart rate variability (hrv) is acknowledged as a reliable marker of cardiac autonomic control, and the frequency of premature ventricular complexes can be an indicator of arrhythmogeneity. the investigators found that hrv was significantly decreased after 24-h sleep deprivation. metoprolol could improve hrv and reduce the frequency of premature atrial and ventricular complexes. but sleepiness and hypotension occurred frequently in subjects treated with metoprolol. statins have significant cardiovascular protective effects in patients with cardiovascular disease. statin not only could regulate serum lipid level, but also have antioxidant and anti-inflammatory properties. this study aimed to investigate (1) the changes in heart rate variability and occurrence of cardiac arrhythmia by continuous ambulatory electrocardiogram (ecg) in young, healthy subjects undergoing 48h sd and (2) the effects of statin on hrv and arrhythmia after this agent was administered prophylactically before sd.

Eligibility criteria:
inclusion criteria: * healthy subjects without cardiovascular disease exclusion criteria: * hypertension * diabetes mellitus * hyperthyroidism * taking medication known to affect cardiovascular, metabolic, gastrointestinal, or immune function * depression * anxiety disorders

Keywords: sleep deprivation
yang yin fu zheng jie du therapy in recurrence of hepatocellular carcinoma less than 3 cm in diameter

Conditions: Hepatocellular Carcinoma

Summary: clinical research of yang yin fu zheng jie du therapy in recurrence of hepatocellular carcinoma less than 3 cm in diameter.the purpose of this study is to observe the efficacy of routine medical care combined with yang yin fu zheng jie du therapy in 1 year recurrence for patients belong to hepatocellular carcinoma less than 3 cm in diameter.


Eligibility criteria:
inclusion criteria: * meet the criteria of hepatocellular carcinoma * ages eligible for study: ≤75 years old; * the size of the main nodule and multi-centricity (single lesion, three nodules ≤3 cm) * after transarterial chemoembolisation (tace) or radiofrequency ablation (rfa) * surgery cannot be allowed; * informed consent from the patient. exclusion criteria: * serious problem of heart, lung, or kidney with severe dysfunction; * pregnant or child breast feeding women; * mental or cognitive disorders; * participating in other drug trials; * who are allergic to the study drug.
negative pressure wound therapy for prevention of groin infection following vascular surgery

Conditions: Infection Wound

Summary: surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. when considering the groin alone, the incidence is around 20% (30% when considering any wound complication). this complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.


Eligibility criteria:
inclusion criteria: * every high-risk patient (meeting one of the criteria of table i) undergoing vascular surgery with groin incision (without ongoing infection) exclusion criteria: * patients who need a transverse incision before endovascular aortic repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.
mayo clinic radiotherapy patient outcomes registry and biobanking study

Conditions: Solid Tumors; Hematologic Malignancies

Summary: to collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.


Eligibility criteria:
inclusion criteria: 1. treated with photon/proton at mayo clinic rochester in radiation oncology 2. radiation therapy for curative intent exclusion criteria: none
pilot study of changing exercise and physical activity behavior in asthma patients

Conditions: Asthma

Summary: the objective of this pilot study is to assess the feasibility and the potential differential impact of a novel intervention of induced positive affect and self-affirmation to increase physical activity in asthma patients.

the goals of this pilot study are to empirically test different interventional approaches to induce positive affect and self-affirmation. at the start of the study all patients in conjunction with their physicians will select a program of mild to moderate physical activity or exercise to be adopted and maintained on a routine basis. patients also will complete the paffenbarger physical activity and exercise index. patients then will be divided into four groups according to the intervention they receive: 1) positive affect; 2) self-affirmation; 3) positive affect and self-affirmation; 4) control. the main outcome is the change in the paffenbarger physical activity and exercise index scores from enrollment to 4 weeks.

Eligibility criteria:
inclusion criteria: * patients will be eligible for this study if their physicians consider them medically able to participate, if they are 18 years of age or older, and if they have a diagnosis of mild to moderate asthma based on the nhlbi asthma expert panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function. exclusion criteria: patients will be excluded from this study for the following reasons: * if they are unable to walk several blocks for whatever reason; * if they have musculoskeletal or neurological deficits that preclude increased physical activity; * if they have other pulmonary diseases; * if they have cardiac disease or other severe comorbidity; * if they are unable to provide informed consent because of cognitive deficits; * if they refuse to participate.

Keywords: asthma behavior change physical activity risk reduction
rapamycin in relapsed acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this is a research study designed to look at the biological effects of two drugs on leukemia cells. in this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. rapamycin is a drug that prevents the body's immune system from working normally. it has been used for many years after kidney transplants to prevent rejection of the organ. recent work suggests that rapamycin may also help treat leukemia and other cancers.

* participants will be randomized into two groups; one group will receive corticosteroid alone, and the other group will receive rapamycin and corticosteroid. * the length of treatment will be 5 days, during which time we will collect blood samples to measure the biologic effects of these drugs. because these drugs will be given for a short period of time only, this study is not designed to treat or cure the participants leukemia. after the 5-day period, participants may resume other cancer-directed therapies.

Eligibility criteria:
inclusion criteria: * documented acute lymphoblastic leukemia (l1 or l2 subtypes) * first or subsequent relapse * 365 days of age or older * greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy * absolute peripheral leukemia blast count of 1000 cells/ul or greater * patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent exclusion criteria: * burkitts leukemia (acute lymphoblastic leukemia l3 subtype) * uncontrolled active infection * pregnancy or mothers who are nursing * patient currently taking rapamycin * patients with significant liver dysfunction as outlined in protocol * severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study * active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial

Keywords: rapamycin corticosteroid all
a study to determine safety & efficacy of autologous human platelet lysate in lateral epicondylitis (tennis elbow)

Conditions: Lateral Epicondylitis (Tennis Elbow)

Summary: this is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human platelet lysate (hpl) in subjects with lateral epicondylitis (tennis elbow). the study is being conducted in 2 centers in india. the primary end points are visual analog score (vas) and patient rated tennis elbow evaluation (prtee) score. the secondary endpoint is improvement in ultrasonography form randomization to end of study.


Eligibility criteria:
inclusion criteria: * subjects with clinical diagnosis of tennis elbow within the last 3 months * subjects both male and female, aged 18-60 years (both inclusive) * subjects who are willing to give informed consent and adhere to the study protocol exclusion criteria: * subjects aged less than 18 and more than 60 years * subjects with autoimmune diseases * subjects with immuno-compromised system * subjects on anti-coagulant therapy or blood thinning medicines like aspirin * subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons. * subjects who have received treatment with corticosteroid injections within the last 6 months
propofol with clonidine and ketamine throughout colon cancer surgery

Conditions: Colon Cancer; Post Operative Pain

Summary: the study showed that combining clonidine and ketamine together can increase the likelihood of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and inflammation.

this study aimd to determine whether propofol infusion combined with clonidine and ketamine is more efficient in lowering the level of il-8, preserving operation stability, and dropping post-operative pain and morphine intake. when paralleled to propofol alone, tiva employing propofol infusion along with pre-operation clonidine and ketamine is effective at preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake. for this study, sixty contestants with asa physical status i and ii, ranging in age from 35 to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. this study excluded participants with a history of heart, renal and liver cell failure, allergic reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or mental illness. using a computer-generated randomization list, the patients were randomly allocated into two groups (30 patients each). the treated group(group t),which got intravenous anaesthesia with tci propofol mixed with clonidine and ketamine, the control group(group c),which received intravenous anaesthesia with tci propofol mixed with a placebo (nacl 0.9%) .a third party was included in this study so neither the researchers nor the research subjects are aware of the intervention which the patients got.

Eligibility criteria:
inclusion criteria: 1. asa physical status i and ii 2. patients with cancer colon exclusion criteria: 1. participants with a history of heart, renal and liver cell failure. 2. allergic reaction to studied drugs, and history of epilepsy, 3. hydrodynamic instability, 4. chronic pain. 5. mental illness.
zd1839 (iressa™) in combination with docetaxel & cisplatin in subjects with metastatic head & neck cancer

Conditions: Head and Neck Cancer

Summary: the primary objective of the study is to evaluate the activity of the combination zd1839, docetaxel and cisplatin in subjects with recurrent and/or metastatic head and neck cancer by estimating the objective response rate (complete response \[cr\] and partial response \[pr\]) at study closure.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18 and 70 years, inclusive 2. histologically- or cytologically-confirmed recurrent and/or metastatic scchn 3. primary tumour site of oral cavity, oropharynx, hypopharynx or larynx 4. at least one uni-dimensionally measurable lesion according to the recist 5. world health organisation (who) performance status (ps) of 0 or 1 6. no previous chemotherapy for recurrent or metastatic disease 7. before subject registration a quality of life questionnaire should be completed exclusion criteria: 1. previous chemotherapy for recurrent or metastatic disease 2. less than 6 months since prior induction or adjuvant platinum and/or taxanes chemotherapy 3. known severe hypersensitivity to zd1839 or any of the excipients of this product 4. known, severe hypersensitivity to docetaxel or cisplatin or any of the excipients of these products, or to other drugs formulated with polysorbate 80 5. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 6. any unresolved chronic toxicity greater than common toxicity criteria (ctc) grade 2 from previous anticancer therapy (except alopecia) 7. absolute neutrophil count (anc) less than 1.5 x109/litre (l), platelets less than 100 x 109/l or haemoglobin less than 10 g/dl 8. serum bilirubin greater than the upper limit of the reference range (ulrr) 9. serum creatinine greater than 1.5 mg/dl despite adequate rehydration 10. creatinine clearance less than 60 ml/min assessed in over a 24 hour urine collection 11. as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) 12. alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 1.5 times the ulrr or alkaline phosphatase (alp) greater than 2.5 times the ulrr 13. evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study 14. pregnancy or breast feeding (women of child-bearing potential) 15. concomitant use of phenytoin, carbamazepine, rifampicin, or barbiturates, or st john's wort 16. treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment 17. any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded

Keywords: head and neck neoplasms cancer of head and neck head and neck cancer head cancer neck cancer
understanding the impact of critical illness on falls risk - a 12 month observational study

Conditions: Critical Illness

Summary: understanding the impact of critical illness on falls risk - a 12 month observational study

this observational study aims to investigate the incidence and risk factors for falls in the first 12 months post hospital discharge in patients following an icu admission. it also aims to determine factors at hospital discharge which may predict future falls risk at 12 months and examine the physical activity levels of icu survivors. furthermore, it also will investigate the relationship between falls, fear of falling and activity limitations and participation restriction. all adult patients in intensive care that have been mechanically ventilated for over 48 hours, and remain in the icu at least 4 days will be considered for inclusion. the primary outcome measure is a 12 month falls diary which commences on hospital discharge. there will also be physiotherapy assessments just prior to hospital discharge, 3, 6, and 12 months post hospital discharge.

Eligibility criteria:
inclusion criteria: * hospitalised adults aged 18 years * with an icu admission requiring invasive mechanical ventilation for at least 48 hours and remain in icu \> 4 days exclusion criteria: * pregnant * insufficient english language skills to read and understand questionnaires and patient information consent form * pre-existing documented cognitive impairment * spinal cord injury or other primary neuromuscular disease or new brain injury * patient unable to be followed up due to geographic location * new lower limb fracture on this admission * liver failure with abdominal distension due to ascites requiring fortnightly drainage * recent history of stroke or major surgery affecting lower limb e.g. total knee or hip replacement in the past 12 weeks * neurological disorders such as parkinson disease or multiple sclerosis * poor premorbid function defined as \<10 metres ambulation +/- gait aid independently * frequent falls history defined as 3 or more falls over 2 months * incarcerated or safety concerns for follow up * discharged to palliative hospice facility * not expected to survive to 3 months post hospital discharge * unable to provide informed consent before hospital discharge due to current cognitive state (e.g. delirium, psychosis)

Keywords: falls intensive care