Kornimate/medical-research-clean huggingface dataset:
lactobacillus reuteri dsm 17938 and prevention of respiratory and gastrointestinal infections in mexican infants

Conditions: Healthy Infants

Summary: randomized, doble blind, clinical, controlled trial aimed to investigate the role of lactobacillus reuteri dsm 17938 in the prevention of gastrointestinal and respiratory tract infections in mexican children who attend day care centers. primary outcome: the primary outcome will be "days with diarrhoea". secondary outcomes: a) days with respiratory tract infections (rti); b) days of absences from day care centre; c) days of antibiotic use; d) days of medical office visits or emergency visits; and e) direct and indirect costs. methods: prospective, randomized, double blind, placebo controlled trial to realize in 260 healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be recruit from child care centers in mexico and randomly allocated to receive either 1 x 108 colony-forming units of lactobacillus reuteri dsm 17938 or placebo, each day for 12 weeks, follow up for other additionally 12 weeks of observation. days with respiratory tract infections (rti); days of absences from day care centre; days of antibiotic use; days of medical office visits or emergency visits; and direct and indirect costs will be compare between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness analysis


Eligibility criteria:
inclusion criteria: * healthy infants * born at term (≥36 weeks of gestation) * any gender * 6 to 36 months old * same socioeconomic background * written informed consent from parents or legal guardians exclusion criteria: * birth weight \<2500 g * congenital anomalies * chronic diseases * failure to thrive * allergy or atopic disease * recent (within the preceding 4 weeks) exposure to probiotics, prebiotics, or antibiotics. * concurrent participation in other clinical trials

Keywords: infants
evaluation of fixed dose combination of glimepiride and metformin in chinese type 2 diabetes patients inadequately controlled with metformin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: * to evaluate the efficacy of fixed dose combination of glimepiride and metformin (amaryl m 1/250mg) in comparison with glimepiride (amaryl) alone in terms of glycemic control as reflected by hba1c during a 20-week treatment period in patients with type 2 diabetes mellitus (t2dm) inadequately controlled with metformin. secondary objectives: * to evaluate the percentage of patients reaching hba1c \< 7% or hba1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (amaryl m 1/250mg) in comparison with glimepiride (amaryl) alone at week 20. * to evaluate the effect on fasting plasma glucose of fixed dose combination of glimepiride and metformin (amaryl m 1/250mg) in comparison with glimepiride (amaryl) alone at week 20. * to assess the safety and tolerability of fixed dose combination of glimepiride and metformin (amaryl m 1/250mg).

the study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. total study duration is up to 23 weeks.

Eligibility criteria:
inclusion criteria: * chinese patients with type 2 diabetes mellitus, as defined by world health organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin * signed written informed consent exclusion criteria: * type 1 diabetes mellitus * hba1c \ 10% * fasting plasma glucose \> 250 mg/dl (\> 13.9 mmol/l) * age \<18 years or age ≥ 80 years * patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening * patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a 52-week post-marketing, observational study to confirm the safety and efficacy of zetia alone or in combination with other lipid-lowering drugs in japanese subjects with hypercholesterolemia (study p05245)

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

Summary: this study is a non-interventional (observational) study in japan to confirm the safety and efficacy of zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. it is being conducted as a post-approval commitment, in accordance with the ministry of health, labour and welfare's guideline on good post-marketing study practice. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.

the population will be selected from 200 institutions in japan.

Eligibility criteria:
inclusion criteria: * subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study. zetia monotherapy patients must be treated with zetia alone. zetia combination therapy patients must be treated with zetia in combination with other lipid-lowering drugs for hypercholesterolemia. exclusion criteria: * patients with a history of hypersensitivity to any ingredient in zetia * patients with serious hepatic function disorder should not be treated with zetia in combination with an hmg-coa reductase inhibitor.
cardiac injury and anaemia following surgery for fractured neck of femur: an observational study study protocol: cardiac injury and anaemia following surgery for fractured neck of femur

Conditions: Anaemia, Myocardial Ischaemia, Fractured Neck of Femur

Summary: blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including mi and aki. we propose to conduct a study with the following aims: 1. to describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur. 2. to use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group. 3. to evaluate highly sensitive serum troponin and urinary maldi-ms as possible endpoints in a future prospective randomised trial of perioperative transfusion.

blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. there is great interest in restrictive transfusion practices (e.g. a transfusion trigger of 70 g l-1), however patients with co-existing cardiovascular disease have been excluded from studies of restrictive versus liberal transfusion strategies. highly sensitive troponin assays are now available, which allow clinicians to reliably detect cardiac injury in increased numbers of patients who have undergone major surgery. troponin release after surgery is common, as high as 40% in some studies. patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including mi and aki. we propose to conduct a study with the following aims: 1. to describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur. 2. to use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group. 3. to evaluate highly sensitive serum troponin and urinary maldi-ms as possible endpoints in a future prospective randomised trial of perioperative transfusion.

Eligibility criteria:
inclusion criteria: * fractured neck of femur * age \>50 * informed consent exclusion criteria: * refusal of consent
posture correction in cubital tunnel syndrome

Conditions: Cubital Tunnel Syndrome

Summary: the primary objective of this study is to determine whether the upright go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in vas scores for pain, numbness, and weakness.

this is a randomized controlled, non-blinded trial. all patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. the nature of the intervention prevents blinding. all patients will be followed for 6 weeks and evaluated for symptom improvement or resolution. all patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. all participants must be amenable to conservative management of cuts, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * adult patients, between 18 and 99 years old * exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers. * nerve conduction study, electromyography, mri or ultrasound results consistent with the diagnosis of cubital tunnel syndrome * ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire exclusion criteria: * history of spinal surgery, hand surgery or hand/wrist fracture * history of cubital tunnel release surgery or carpal tunnel syndrome * pregnancy or lactation * known allergic reactions to silicon * long-standing history of t2dm, documented neuropathic pain
effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients

Conditions: Postoperative Confusion

Summary: this study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.


Eligibility criteria:
inclusion criteria: * written informed consent. * ongoing one-lung ventilation surgery. * american society of anesthesiologists class i to iii. * aged between 55 and 75 years old. * body mass index between 18 and 25 kg/m2. exclusion criteria: * systolic blood pressure more than 180 mmhg or lower than 90 mmhg,diastolic blood pressure more than 110 mmhg or lower than 60 mmhg. * serious heart,liver,kidney, pulmonary, and endocrine disease or serious infection. * suspected or confirmed difficult airway. * history of abnormal anesthesia. * suspected of malignant hyperthermia. * use of sedative and antidepressant drug or serious alcoholism * mini-mental state examination less than 17. * highest academic degree below grade 6 in primary schools * patients inability to exchange with serious visual and hearing impairment or mental disability. * history of shock. * carotid artery stenosis and central nervous system disease such as stroke, epilepsy. * allergic to investigational products or with other contraindication. * participated in other study within 30 days .
endoscopic stenting in crohn related strictures

Conditions: Intestinal Strictures Related to Crohn´s Disease

Summary: prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to crohn´s disease.


Eligibility criteria:
inclusion criteria: * benign high-grade crohn stricture exclusion criteria: * unwillingness to participate * planned surgery * high risk for bleeding
prospective hiv chemotherapy cohort study

Conditions: HIV; Cancer

Summary: human immunodeficiency virus (hiv) infection is very successfully treated with a type of therapy called highly active antiretroviral therapy (haart). although haart has made a great improvement to the health and lives of all people living with hiv, haart cannot be stopped because it is not able to 'cure' or eliminate the hiv virus from all cells in the body - the remaining viruses are referred to as 'latent' or sleeping virus. as soon as the haart treatment is stopped the virus comes back (wakes up). it is for this reason that stopping haart treatment is not recommended. however, it may be that other drugs if given with haart could have a stronger effect on the latent virus. there is some evidence from laboratory research that suggests that some of the drugs we use to treat certain types of cancer may have an effect on the latent virus. the purpose of this research study is to use new laboratory research technology to measure the amount of 'latent' virus in people who are treated with haart who then need to use chemotherapy treatments for cancer. we will look at whether the levels of hiv virus are reduced in patients having chemotherapy by looking at the virus levels before, during and after chemotherapy treatment. we do not know very much about how hiv persists in the body despite therapy and unless new approaches are developed, removal of the hiv virus from all cells in the body will not be possible.

study design this study will be performed at one investigational site in the uk. this is a single centre, prospective observational cohort study of hiv positive individuals on suppressive haart with malignancy undergoing chemotherapy. eligibility individuals receiving haart and diagnosed with either lymphoma or kaposi's sarcoma receiving combination chemotherapy agents, which include the vinca alkaloids and taxanes, will be eligible for this study.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years and able to give written informed consent * be aware of their hiv status and the diagnosis of malignancy * have a plasma viral load of \< 50 hiv-1 rna copies/ml (on suppressive haart) at enrolment * be designated to receive cytotoxic chemotherapy including one or more of the following agents: r-chop, abvd, liposomal doxorubicin (caelyx) or liposomal daunorubicin (daunoxome) or paclitaxel exclusion criteria: * patients not receiving haart * a detectable (\>50 hiv-1 rna copies/ml) hiv plasma viral load at screening * opportunistic infections * unable or unwilling to give informed consent

Keywords: hiv chemotherapy cohort cancer haart malignancy
the effect of walking in kidney transplant patients

Conditions: Kidney Transplant; Complications; Cardiac Disease

Summary: cardiovascular diseases are among the most common causes of death in kidney transplant patients. physical activity is of great importance in preventing cardiovascular diseases after transplantation. although regular physical activity is recommended in international guidelines to prevent post-transplant mortality and morbidity in kidney transplant patients, studies have shown that patients do not follow regular physical activity instructions.the aim of our project is to examine the effect of pedometer-assisted physical activity on metabolic parameters after kidney transplantation.

patients with kidney transplant surgery will be randomized to the intervention (n: 34) and control groups (n: 34), respectively, according to the transplant surgery date. intervention and control groups will be given the same training on the importance of physical activity during discharge training. the pedometer will be given to the intervention group to evaluate the activity level, and it will be said that their goal is to take 2000 steps in 20 minutes a day after discharge. patients will be asked to carry the pedometer during physical activity, and to write down the number of steps they take in 20 minutes on the form given to them for 90 days. patients in the control group will only be advised to do physical activity every day and will be asked to record the minutes of physical activity they do for 90 days. metabolic parameters of the patients in the intervention and control groups will be examined at the end of the 4th and 12th months. these parameters are blood pressure, body mass index, complete blood count (hemoglobin, leukocyte, thrombocyte), blood glucose, sodium, potassium, calcium, liver enzymes, serum creatinine, total and indirect bilirubin, albumin and total cholesterol levels.

Eligibility criteria:
inclusion criteria: • over the age of 18 and under the age of 65, * kidney transplantation at the center where the study was conducted between the research dates, * there is no activity restriction recommendation by the physician, * patients who agree to participate in the study. exclusion criteria: * multiple organ transplantation at the same time, * death or graft loss/rejection in the hospital before discharge, * patients with physical activity restrictions by the physician, * patients who are re-hospitalized within the first 3 months after discharge

Keywords: transplantation exersize heart diseases kidney nursing care
complications in parotid surgery

Conditions: Facial Palsy

Summary: the investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. also other complications occurring within 12 months of operation were recorded.

patients who underwent parotid surgery at the department of otorhinolaryngology - head and neck surgery, helsinki university hospital, helsinki, finland, between september 2011 and november 2012 were prospectively enrolled. exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.

Eligibility criteria:
inclusion criteria: * parotid gland tumour surgery exclusion criteria: * age under 18 * suspicion of malignancy or facial schwannoma * a tumor extending into the parapharyngeal space * previous parotid surgery exposing facial nerve
feasibility study of the adult congenital heart disease-coping and resilience (achd-care) trial

Conditions: Heart Defects, Congenital

Summary: the psychosocial development of adults with congenital heart disease (chd) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. one-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general canadian population. unfortunately, most adults with chd and significant depression or anxiety do not receive mental health treatment. despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult chd population. our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. the overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with chd.


Eligibility criteria:
inclusion criteria: * documented congenital heart disease (chd), as confirmed by echocardiogram, cardiac catheterization, or previous surgery * age greater than or equal to 18 years * english-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an english-language group * no planned surgery during patient's participation in the study * clinically-elevated score (i.e \>=8) on the hospital anxiety and depression scale depression (hads-d) or anxiety (hads-a) subscale exclusion criteria: * current psychotherapy or pharmacotherapy * significant cognitive impairment, psychosis, or personality disorder as documented in medical chart * report of suicidal intent during screening

Keywords: quality of life psychosocial support systems randomized controls as topic cognitive therapy feasibility studies
magnetic resonance (mr) enterography assessment of post operative small bowel length in short bowel syndrome patients

Conditions: Short Bowel Syndrome

Summary: it is essential to know intestinal length and anastomotic type in post-operative short bowel syndrome patients. these parameters can help predict long-term intestinal failure with long-term parenteral nutrition usually needed for smallest lengths. sometimes these parameters are unfortunately missing for lack of intraoperative measurement. thus, it is necessary to develop non-invasive and reproducible techniques to assess small bowel length. this is the reason why the investigators will evaluate magnetic resonance (mr)-enterography and barium follow-through in this indication. there are at this time only two small studies evaluating barium follow-through for intestinal length measurement, and none evaluating mr-enterography. however, a major advantage of the latter is the lack of radiation exposure and possibility to perform 3d. this will be an open labelled single center crossover study. short bowel syndrome patients of the investigators center will be included after consent. the sequence of exams (mr enterography followed by barium follow-through or vice-versa) will be randomly assigned. peroperative short bowel length measurement will be available for all patients. there will be one month between the two exams. the main objective of this study is to assess the performance of mr-enterography in short bowel measurement in short bowel syndrome patients, the gold standard being peroperative length. secondary objectives are to assess the performance of barium follow-through in short bowel measurement in these patients, and to show that barium follow-through does not perform better than mr-enterography. for that purpose the investigators will include 50 patients over 2 years.


Eligibility criteria:
inclusion criteria: * intraoperative small bowel length \< 200 cm * males and females between 18 and 85 years of age * patient with social insurance * signature of informed consent exclusion criteria: * allergy to contrast product * enterostomy closure expected within 2 months after randomization * pregnancy or breast feeding woman * swallowing disorders * deprivation of liberty * contraindications to magnetic resonance imaging (pace-maker, metal implant, known allergy to gadolinium)

Keywords: gastrointestinal tract [a03.556]