Kornimate/medical-research-clean huggingface dataset:
does dietary and lifestyle counseling prevent excessive weight gain during pregnancy? a randomized controlled trial

Conditions: Obesity; Pregnancy

Summary: the purpose of this study is to determine if an organized, consistent program of dietary and lifestyle counseling will prevent excessive gestational weight gain.

excessive gestational weight gain is common with about one third of women gaining more weight in pregnancy than is recommended. unfortunately, the prevalence of excessive gestational weight gain is increasing. gestational weight gain greater than that recommended by the institute of medicine (iom) is associated with increased risk of gestational complications (hypertension, diabetes, and preeclampsia), infant macrosomia, and complications in delivery including increased risk of cesarean delivery. currently, there is no evidence-based prenatal counseling protocol available to prevent excessive gestational weight gain. we hypothesize that consistent counseling on appropriate pregnancy diet, weight gain, and the potential complications of excessive gestational weight gain will result in fewer women gaining above the iom recommendations.

Eligibility criteria:
inclusion criteria: 1. establish prenatal care at 6 - 16 weeks gestation 2. 18-49 years of age 3. receive their entire prenatal care at the resident obstetrics clinic 4. english and/or spanish speaking 5. singleton gestation. exclusion criteria: 1. establish prenatal care \>16 weeks gestation 2. non-english or non-spanish speaking 3. multiple gestation pregnancy 4. bmi \> 40 5. preexisting diabetes, untreated thyroid disease, or hypertension requiring medication or other medical conditions that might affect body weight 6. delivery at institution other than cmc-main 7. pregnancy ending in a premature delivery (\< 37 weeks) 8. limited prenatal care (\<4 visits)

Keywords: obesity pregnancy exercise nutrition obesity in pregnancy
vitamin c effectiveness in preventing urinary tract infections after gynecological surgeries

Conditions: Catheter-Associated Urinary Tract Infection

Summary: double-blind placebo-controlled randomized trial aiming to assess the role of vitamin c supplementation in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

women undergoing elective gyn surgery are a particularly high-risk group for utis, because these operations involve surgery adjacent to the bladder and delayed bladder emptying is common. it has been estimated that the 'risk of urinary tract infections among women undergoing elective gynecologic gyn surgery is between 10-64%, following catheter removal. catheterization, in itself, poses a significant risk for utis because insertion and removal introduce bacteria and cause trauma, both of which may increase the risk of utis. the incidence of uti for women in the general population is estimated to be 3-4% per year vs 5% per day of catheterization. for this reason, multiple interventions have been studied for the prevention of utis. ascorbic acid (vitamin c) is often suggested as a supplement that can prevent recurrent utis by acidification of the urine. strong clinical evidence to support this claim in healthy adult women is lacking. because of the lack of literature regarding the use of vitamin c as a prophylactic agent for the prevention of utis, the investigators wish to conduct this study to assess the potential therapeutic efficacy of ascorbic acid in preventing utis after elective gyn surgery.

Eligibility criteria:
inclusion criteria: * nonpregnant women * 18 years of age or older * undergoing elective gyn surgery exclusion criteria: * pregnant women * already taking vitamin c supplementation * nephrolithiasis * congenital anomaly or neurogenic bladder * allergy to ascorbic acid * on therapeutic anticoagulant medicine during the 6 weeks after surgery * gynecological surgery involving fistula repair or a vaginal mesh removal * positive urinalysis in the pre-admission unit * recurrent utis * diabetes * g6pd * hemochromatosis * renal disorders

Keywords: ascorbic acid vitamin c elective gynecologic surgeries cauti
introduction of microsystems in a level 3 neonatal intensive care unit

Conditions: Stress, Psychological; Inflammatory Bowel Diseases; Lung Diseases; Infant Nutrition Disorders; Eye Manifestations; Neurodevelopmental Disorders

Summary: the advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (nicu). it has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome. despite the growing knowledge around the need for reconstruction of large nicus to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. at the mcmaster children's hospital (mch), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care. a working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model. the study was retrospectively registered.


Eligibility criteria:
inclusion criteria: * all preterm and term infants admitted to mcmaster children's hospital nicu exclusion criteria: * no exclusion criteria
is doppler necessary in haemorrhoidal artery ligation operation?

Conditions: Piles; Bleeding

Summary: haemorrhoidal artery ligation operation (halo) is an operation that ties off vessels to piles. this study examines whether the ultrasound (doppler) is necessary to guide this tying off or not.

halo (haemorrhoidal artery ligation operation) has proved to be a popular and effective treatment for bleeding piles. currently the halo is a doppler guided procedure though when the doppler mechanism does not function it has been noted that the results are similar. this prompts the question does the doppler guide the operation to tie off the important vessels to shrink he piles, or can the vessels that underlie the visible piles be treated without doppler. professor phillips from st.marks has reviewed the protocol and agrees that it is well designed and worthwhile.

Eligibility criteria:
inclusion criteria: * for consenting adults (18-90 years) with grade one and two piles listed for halo at poole hospital by three consultants trained in the halo technique, the patients will be offered to be involved in the study. exclusion criteria: * other grades of piles, age outside 18-90 or other anal condition

Keywords: hemorrhoids treatment piles bleeding halo
d2 versus d4 corifollitropin alfa in gnrh antagonists

Conditions: Infertility

Summary: the purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (coh) in an antagonist protocol.

corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. it offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with gnrh antagonist co-treatment for ivf or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rfsh. normally, this medication is started on day 2 of the cycle. in the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.

Eligibility criteria:
inclusion criteria: * \< 36 years old on day of randomisation * fsh \< 12 (in the early follicular phase) * normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation. * regular menstrual cycles of 21-35 days, presumed to be ovulatory. * bmi ≤ 29 * weight \> 60 kg * \< 3 previous trials * icsi * randomisation at out-patient clinic exclusion criteria: * ≥ 36 years old on day of randomisation * endometriosis ≥ grade 3 * pcos * poor responders (development of \< 4 follicles in a previous ivf/icsi cycle) * endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Keywords: icsi gnrh antagonist corifollitropin alfa
medpass trial: medpass versus conventional administration of oral nutritional supplements

Conditions: Malnutrition

Summary: the aim of the randomized-controlled, single-center medpass trial is to assess the effects of medpass versus conventional administration of oral nutritional supplements (ons) on energy and protein intake in medical and geriatric inpatients.

disease related malnutrition (drm) in hospitalized patients is a common problem.the oral nutritional support with ons is one of the first and most common treatment approach in the patients at nutritional risk. treatment with ons may reduce mortality and complications in hospitalized patients. there are no standards on the type of administration of ons in terms of timing throughout the day leading to individual approaches. ons are conventionally served as snacks by nurses, nursing aids or gastronomy personnel between the main meals. the medpass-mode offers a different approach by serving ons together with the medication, three or four times per day, in unusually small portions. preliminary trials suggest that compliance and cost effectiveness may be improved with the medpass-mode. enhancing compliance to ons may not consequently lead to improved total energy and protein intake throughout the day. there has never been a large trial in which total energy- and protein intake of the subjects was studied consequently and systematically throughout the hospitalization. therefore, this trial will bridge this gap by studying total energy- and protein intake as primary outcomes.

Eligibility criteria:
inclusion criteria: * nutritional risk screening (nrs-2002) total score ≥3 points according to routine screening at admission within 72 hours * expected hospital los ≥3 days after screening (as estimated by the treating physician) * patient qualifies for ons and approves prescription * age \>18 years * willingness and ability to provide informed consent exclusion criteria: * initially admitted to critical care unit * immediate post-operative phase (\<7 days post-surgery) * dysphagia with the inability to swallow liquids * supplemental enteral and/or parenteral nutrition * admitted with, or scheduled for, total parenteral nutrition or tube feeding * mini mental state examination \< 16 points * hospitalized due to anorexia nervosa * hospitalized due to acute pancreatitis * hospitalized due to acute liver failure * cystic fibrosis * patients after gastric bypass surgery * patients with short bowel syndrome * terminal condition (end of life situation) * poor skills in german language (study language)

Keywords: malnutrition
percutaneous endoscopic gastrostomy before definitive concurrent chemoradiation therapy for esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this phase ii randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (ccrt) in patients with esophageal squamous cell carcinoma(escc) by assessing their weight, nutritional status, performance status and treatment response.

this phase ii randomized study is to determine the efficacy of percutaneous endoscopic gastrostomy before definitive concurrent chemoradiotherapy (ccrt) in patients with esophageal squamous cell carcinoma(escc) by assessing their weight, nutritional status, performance status and treatment response. all patients will receive definitive radiotherapy combined with three cycles of s-1 (40mg/2, bid, po) on d1-14, d22-35, d43-56. the primary endpoint is percentage of recent weight loss at the end of ccrt. the secondary endpoints are nutrition status, objective response rate, overall survival, toxicity and intestinal flora changes in blood, urine and stool specimens.

Eligibility criteria:
inclusion criteria: * histologically confirmed esophageal squamous cell carcinoma * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria. * eastern cooperative oncology group (ecog) performance status 0-1. * estimated life expectancy of at least 6 months * no contraindications for chemotherapy or radiotherapy * patients and their family signed the informed consents exclusion criteria: * severe gastrointestinal impairment or enteral nutrition intolerance * severe vomiting, gastrointestinal bleeding or intestinal obstruction * severe malnutrition * patients with contraindications for percutaneous endoscopic gastrostomy, including uncorrected coagulopathy or thrombocytopenia, varices caused by portal hypertension, or other gastric diseases * not suitable for this study judged by researchers

Keywords: esophageal squamous cell carcinoma percutaneous endoscopic gastrostomy concurrent chemoradiotherapy enteral nutrition support
a clinical trial of csl's 2010/2011 formulation of enzira® in a healthy adult population

Conditions: Influenza

Summary: the purpose of this study is to determine whether the 2010/2011 formulation enzira vaccine is safe and elicits an immune response to seasonal influenza in healthy adults.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and older at the time of the first study vaccination. exclusion criteria: * known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the study vaccine. * clinical signs of an active infection * vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry * females who are pregnant or lactating
manual therapy treatment for myofascial pain

Conditions: Myofascial Pain Syndromes

Summary: this study is a pain intensity evaluation in patients with myofascial pain submitted kinesitherapy after trigger point injection.

randomized prospective study conducted on 30 patients of both genders ranging in age from 18 to 60 years, with neck and shoulder girdle myofascial pain syndrome (mfs), with a duration of ≥ 4 months and pain intensity ≥ 4. trigger point injection of 1 ml 0.25% bupivacaine at each point, once a week for 8 weeks (t1 to t8). group 1: kinesiotherapy once a week for 8 weeks group 2: not submitted to kinesiotherapy evaluation of pain intensity on the first assessment (t0) and after 1, 2, 3, 4, 5, 6, 7, 8, and 9 weeks

Eligibility criteria:
inclusion criteria: * myofascial pain of neck and shoulder girdle, lasting ≥ 4 months, pain intensity ≥ 4. exclusion criteria: * arrhythmia * heart block * coagulopathy * cognitive alterations and infection at the site * patients using anticoagulants, and pregnant women

Keywords: myofascial pain trigger point injection manual therapy
programmable timer in the bladder rehabilitation treatment of oab

Conditions: Overactive Bladder; Urinary Incontinence

Summary: the purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer

daytime urinary incontinence is common in children. at the age of 7 a prevalence of 2-9 % has been reported. daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified. the symptom based diagnosis oab (overactive bladder) is most often used to describe daytime urinary incontinence in children. oab is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency. when urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with oab. it is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. the treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. the treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. however there has not been published studies of the effect of programmable timer. hypothesis: * daytime urinary incontinence in children aged 5-15 with idiophatic oab can in 50 % of cases be cured by bladder rehabilitation * the compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment. material and methods: 100 children with idiopathic oab will be recruited from the center of child incontinence, skejby university hospital, aarhus, denmark. after a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer. the effect of the treatment will be estimated based on home recordings.

Eligibility criteria:
inclusion criteria: * daytime urinary incontinence with at least 1 episode of at least 1 ml per week * more than 6 voidings per day * informed consent exclusion criteria: * known diseases of the kidneys or urinary tract besides oab * receiving treatment with drugs that have an effect on the urine production or bladder function

Keywords: overactive bladder children bladder rehabilitation
direct resuscitation of the open peritoneum

Conditions: Wound; Abdomen; Abdomen, Acute; Wound Surgical

Summary: the drop trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. the current standard of care at sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. in this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. this trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner


Eligibility criteria:
inclusion criteria: * ≥18 years of age * have index operation performed by one of the trauma and acute care surgeons at sanford medical center fargo * require an open abdomen due to a non-traumatic cause and placement of an abthera™ wound vacuum * cognitively impaired adults will be included if a legally authorized representative is available to provide informed consent. exclusion criteria: * patients under the age of 18 * vulnerable populations such as pregnant women and prisoners * patients with open abdomens as the result of trauma * non-english speaking (due to time constraints pre-operatively and the length of time necessary to secure translation services, non-english speaking patients will not be enrolled).
open label phase ii study of bay 43-9006 in chronic myelogenous leukemia (cml) patients resistant to gleevec

Conditions: Chronic Myelogenous Leukemia

Summary: the purpose of this study is to evaluate the anti-cancer activity and safety of bay 43-006, in patients who have chronic myelogenous leukemia that resisted to gleevec treatment, one of the standard medication administered for these patients.


Eligibility criteria:
inclusion criteria:- have philadelphia chromosome positive chronic myelogenous leukemia (cml) in chronic phase, as per ibmtr criteria- have documented hematologic resistance to gleevec (imatinib) following a prior hematologic response to gleevec administered at doses of at least 400 mg/d for at least 3 months.- have wbc \>20 x 109/l at study entry- have an ecog performance status. status of 0, 1 or 2- have an anticipated survival of at least 16 weeks.- be able to comply with study procedures and follow-up examinations.- signed informed consent must be obtained prior to any study specific procedures. exclusion criteria:- congestive heart failure \> class ii as defined by the new york heart association functional classification (nyha)- cardiac arrhythmias requiring antiarrythmics (excluding beta blockers or digoxin)- active coronary artery disease or ischemia- history of hiv infection or chronic hepatitis b or c - active clinically serious infections (\> grade 2 nci-ctc)- patients with seizure disorder requiring anti-epileptic drugs- history of solid organ allograft
treatment of recurrent hepatitis c after liver transplantation

Conditions: Liver Transplantation; Hepatitis C

Summary: in france, 50% of the hepatitis c virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. transplant infection by hepatitis c virus is constant after transplantation. this recurrence usually causes chronic liver disease, in 50 to 80% of the patients. the interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. the objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis c recurrence in the transplanted liver.

several therapeutic patterns have been described for the treatment of hepatitis c post-transplantation recurrence. a combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. in our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. at the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. efficacy will be assessed on virological response after 30 months of treatment.

Eligibility criteria:
inclusion criteria: * first liver transplantation or retransplantation in the month after initial transplantation * patients aged over 18 years * post-hepatitis c cirrhosis * equilibrated immunosuppressive treatment * positive pcr for hepatitis c virus * liver biopsy between 6 months and 5 years after the transplantation with a fibrosis metavir score at least f1 * hemoglobin ≥ 10 g/dl * platelet count ≥ 50.000/mm3 * normal tsh value * serum creatinine \< 200µmol/l * informed written consent exclusion criteria: * chronic rejection * acute rejection at inclusion * multi-visceral transplantation * renal or cardiac failure, severe sepsis * uncontrolled diabetes * positive serology for hepatitis b or hiv at inclusion * ebv virus replication at inclusion * hepatocellular carcinoma at inclusion * cirrhosis with a fibrosis metavir score f4 at inclusion * inclusion in another clinical trial less than one month ago * pregnancy * contra-indication to ribavirin or interferon * history of or current psychiatric troubles * thyroid disease uncontrolled by treatment

Keywords: hepatitis c viral recurrence ribavirin / interferon