Kornimate/medical-research-clean huggingface dataset:
mnch programming in southwest uganda maternal and child health in bushenyi and rubirizi districts, uganda

Conditions: Child Mortality; Maternal Mortality (All Cause)

Summary: the investigators will assess whether in bushenyi district in southwestern uganda, a two year intervention providing comprehensive mnch programming will: * reduce morbidity and mortality for children under five years old and; * improve access to maternal health services compared to a control community without mnch intervention? hypothesis: comprehensive maternal, newborn and child health programming in bushenyi distrcit can have a positive impact on morbidity and mortality for children under five years and will improve access for women to maternal health services which may lead, in the longer term, to decreased maternal mortality.

a detailed impact assessment will be carried out for the duration of the mnch training and support initiative in bushenyi district, using mixed methods. the study will assess 8 of the 11 key core mnch indicators as identified by cida as a priority. other information to be collected such as demographics and patterns of health care use, and prevalence of disease will help health planners in the districts, and will be helpful in sub analysis and interpretation of findings. the main study will use household surveys in both districts at baseline, midline and endline. other tools will include pre and post qualitative surveys (fgds, kii) and analysis of operational data. the main study group will be representative communities and health centres within bushenyi district who will receive intervention between 2012 and 2014; rubirizi district will serve as a control area for this study but will received selected mnch services starting in 2013 after midline data are collected.

Eligibility criteria:
inclusion criteria: * all households living in selected communities; all women 15-49 living in selected communities exclusion criteria: none

Keywords: maternal newborn child
intrabdominal hyperthermic chemotherapy and pancreatic cancer

Conditions: Resectable Pancreatic Adenocarcinoma

Summary: a randomized, multidisciplinary study, phase ii-iii clinical trial.the study is opened to the incorporation of other centers that would increase the power of the obtained results . our hypothesis considers that using hyperthermic intra-abdominal chemotherapy,hipec, with gemcitabine after cytoreductive surgery ,will decrease tumor progression of pancreatic cancer by reducing the neoplastic volume and subpopulation of pancreatic cancer stem cells, improving the survival of patients with pancreatic cancer, and decreasing the recurrence of the disease

according to the incidence in the area of the university general hospital, ciudad real, hgucr, authors will include a population of 42 patients, n = 21 in each group, i and ii, with diagnosis of adenocarcinoma of the pancreas, which will be surgically resected with curative intention, in the next two years, 2017-2018, with extended follow-up for at least two years more for survival study accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 21 subjects were required in the first group and 21 participants in the second group to detect as statistically significant difference between two proportions, for group i is expected to be 0.05 and for group ii 0.4, in relation to survival in five years. it has been estimated a rate of loss of patients of 10% * group i. after cytoreductive surgery, r0, and intestinal reconstruction, the patient after multidisciplinary study will receive adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles * group ii.after a r0 cytoreductive surgery, hipec is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles the aim is identifying morbidity and mortality associated to treatment by cytoreductive surgery and hipec with gemcitabine+ systemic chemotherapy,group ii, respect to a conventional treatment group that includes cytoreductive surgery with systemic chemotherapy, group i,and identifying survival of the experimental group with treatment with cytoreductive surgery and hipec with gemcitabine ,respect to the conventional treatment group,gi

Eligibility criteria:
inclusion criteria: · resectable pancreatic adenocarcinoma exclusion criteria: * voluntary refusal to participate in the trial * existence of distant disease that contraindicates the surgical treatment * patients with preoperative or intraoperative locoregional unresectable pancreatic cancer * existence of synchronous neoplastic disease * exclusion after perioperative anesthetic study

Keywords: pancreatic cancer gemcitabine pancreatic carcinomatosis intrabdominal hyperthermic chemotherapy
the role of clinical pharmacist in management of ddis in chf patients

Conditions: Chronic Heart Failure

Summary: drug-drug interactions (ddis) are common in patients with chronic heart failure (chf) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. data bases often detect ddis that are of high clinical relevance. the investigators have performed this study in order to detect clinically significant ddis and to diminish their occurrence by sending notification about ddis to attending physician.


Eligibility criteria:
inclusion criteria: * patients admitted with diagnosis of chf i50.0 - i50.9 and i11.0 - i11.9 (icd-10) * patients treated with at least two drugs exclusion criteria: * patients admitted to other conditions

Keywords: chronic heart failure drug-drug interactions pharmacist's intervention
a study of mk-6552 in sleep deprived healthy participants (mk-6552-003)

Conditions: Healthy; Narcolepsy

Summary: this study examined the safety of the drug mk-6552 and if people tolerated it. it also studied whether mk-6552 works better than placebo for staying awake in sleep deprived healthy participants.


Eligibility criteria:
inclusion criteria: criteria include but are not limited to the following: * is in good health * body mass index (bmi) between 18 and 32 kg/m\^2, inclusive. exclusion criteria: criteria include but are not limited to the following: * history of or current hypertension, * has a history of sleep disorders:
clinical investigation of the lcs® complete posterior stabilized mobile-bearing total knee system

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Juvenile Arthritis

Summary: prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the lcs® complete mobile-bearing total knee system

prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of lcs® complete mobile-bearing total knee system. no comparison group. 12 month enrollment, 12 month post-operative evaluation. follow-up intervals: pre-op, 3 month, 6 month, and 12 month.

Eligibility criteria:
inclusion criteria: * m/f * 18-80 * diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis. * skeletally mature, sufficient bone stock to seat and support prosthesis * willing/able return for follow-up. * subject is willing and able to provide informed patient consent for participation in the study exclusion criteria: * history of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue * communicable diseases that may limit follow-up * medical-legal or workers compensation claims.

Keywords: total knee replacement total knee arthroplasty osteoarthritis rheumatoid or other inflammatory arthritis post-traumatic or juvenile arthritis
functional comprehensive assessment by ivus reconstruction in patients with suspected ischemic heart disease (feature)

Conditions: Ischemic Heart Disease

Summary: investigating the diagnostic accuracy of online ultrasonic flow ratio (ufr) assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived fractional flow reserve (ffr) as a reference standard.

this is a prospective, single-center, observational registry study of patients with suspected ischemic coronary artery disease. the purpose of this registry is to investigate the accuracy of online ufr assessment to identify hemodynamically significant coronary stenosis in patients with suspected ischemic heart disease using angiography-derived ffr as a reference standard. study population and sample size calculation are based on the diagnostic performance of previous studies, where an accuracy of 92% was found for ufr. investigators conservatively estimate the diagnostic accuracy of online ufr assessment as 90% for consecutively enrolled patient population, and with a test target value set as 78% at a two-side significance level of 0.05, statistical power as 90%. considering incomplete ffr/ufr data of 10% at most, a total of 112 patients need to be enrolled.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years * patients suspected with ischemic heart disease * ≥ 1 diseased vessel with angiographic percent diameter stenosis between 40% and 80% in a vessel ≥ 2.5mm by visual estimation * target vessels are limited to major epicardial coronary arteries (left anterior descending artery \[lad\], left circumflex artery \[lcx\], right coronary artery \[rca\]) exclusion criteria: * patients with previous coronary artery bypass grafting (cabg) * myocardial infarction within 72h of coronary angiography * allergy to the contrast agent or adenosine * left main coronary artery stenosis ≥ 50% * target vessel with in-stent restenosis * target vessel with severe tortuosity or angulation * 100% occlusion of target vessel * target vessel spasm or injury * target vessel with severe myocardial bridge * target vessel with severe thrombosis * intravascular ultrasound (ivus) pullback fails to cover the complete target lesion * presence of false lumen at target vessel based on ivus * a serum creatinine level \>150 umol/l, or a glomerular filtration rate \< 45 ml/kg/1.73 m\^2 * heart failure * ineligible for diagnostic intervention (ivus or ffr examination)
effect of dietary salicylate in aspirin exacerbated respiratory disease

Conditions: Chronic Rhinosinusitis; Aspirin Exacerbated Respiratory Disease; Asthma; Aspirin Sensitivity

Summary: aspirin-exacerbated respiratory disease, or aerd, consists of aspirin sensitivity, asthma and nasal polyps. it is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. however, these treatments have potential adverse effects. a theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. a current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. the hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.


Eligibility criteria:
inclusion criteria: * adult patients * aspirin-exacerbated respiratory disease exclusion criteria: * recent use of prednisone or other systemic steroids (greater than 3 doses in past 3 months) * endoscopic sinus surgery or polypectomy within the past 6 months * other significant systemic disease, including renal failure, or immunocompromised state.

Keywords: chronic rhinosinusitis aspirin exacerbated respiratory disease asthma aspirin sensitivity salicylate
study of enmd-2076 in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: safety, tolerability, maximum tolerated dose and clinical benefit of enmd-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

the study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with enmd-2076 administered orally once daily over a range of doses in patients with relapsed or refractory multiple myeloma.

Eligibility criteria:
major inclusion criteria: 1. histological evidence of mm and evidence of relapse or refractory disease. patients with non secretory myeloma or plasmacytoma only will be excluded. 2. patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents. 3. age ≥18 years. 4. ecog performance status 0-2. 5. patients must have adequate organ and marrow function major exclusion criteria: 1. prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug enmd-2076. 2. prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis). 3. concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. 4. have unstable angina pectoris or recent myocardial infarction (within 6 months. 5. have uncontrolled hypertension or congestive heart failure.
the effectiveness of a post-icu recovery program on relatives

Conditions: Intensive Care Unit Syndrome; Relatives

Summary: relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (hrqol). recovery programs have been tested, but its effectiveness is sparse. the hypothesis is that relatives to former intensive care patients will improve their hrqol one year after intensive care. we want to determine whether relatives to former intensive care patient's benefits from a recovery programme with improved hrqol, sense of coherence (soc) and symptoms of anxiety, depression and ptsd compared to standard care one year after intensive care.

relatives of intensive care patients are affected of critical illness with symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired mental health. recovery programs aimed at patients after a stay at the intensive care unit (icu) have been tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. the aim is to determine whether relatives to former intensive care patients benefits from a recovery programme with improved health-related quality of life (hrqol), sense of coherence (soc), and symptoms of anxiety, depression, and ptsd compared to standard care during the first year after icu discharge. this was a sub-study of the "recovery and aftercare in post-intensive care therapy patients" (rapit) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled trial. we recruited patients and relatives concurrently during the rapit-trial study-period, and now we are doing analysis on relatives. we wants to include adult relatives defined by the patients from 10 danish icus. the study was powered to detect an effect size of a 5-point increase in the medical health survey short-form 36 (sf-36) on the mental component score (mcs) in the intervention group at 12 months post-icu. power calculation was based on an expected distribution of mcs from a matched population with a mean of 36.7 (sd 11.7) from a similar study. with a statistical power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in each group to complete follow-up. the statistical analysis plan was based on intention-to-treat (itt) as was per protocol (pp) analysis and investigating difference between intervention and controls. relatives were considered to have received the intervention if the patient attended at least one of the three consultations, which accounted for the pp analysis.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * defined by the patients exclusion criteria: * if the patients dropped out or died during the study period

Keywords: health-related quality of life anxiety depression post-traumatic stress disorder recovery programme rehabilitation follow-up programme aftercare randomized controlled trial multicentre
a prospective trial comparing transoral endoscopic thyroidectomy vestibular approach (toetva) and conventional open thyroidectomy

Conditions: Benign Thyroid Nodule; Suspicious Malignant Thyroid Nodule

Summary: to determine if transoral endoscopic thyroidectomy vestibular approach (toetva) is a safe and effective procedure compared to traditional open thyroidectomy. surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.

this is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (toetva) and 20 patients to the control group under traditional open approach. subjects will be assigned to either group without randomization. patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using voice handicap index (vhi) and md anderson dysphagia inventory (mdadi) outcomes. surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.

Eligibility criteria:
inclusion criteria: * benign thyroid nodule less than 4cm * suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery exclusion criteria: * patients under 18 years old * contraindication to general anaesthesia * vulnerable population (e.g. cognitive impairment, pregnant) * previous anterior neck surgery * previous radiotherapy at the head and neck region * malignant thyroid nodule \> 2cm * presence of another malignancy, lateral neck, or distant metastasis * retrosternal goitre * cervical spine disease precluding extension of the neck * obesity with bmi \> 35kg/m2 * severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention * untreated active infection * non-correctable coagulopathy * emergency surgery

Keywords: thyroid nodule
comparison of phenylephrine and ephedrine in the treatment of hemodynamic disorders after spinal anesthesia in the elderly

Conditions: Hip Fractures; Elderly Patients; Spinal Anesthesia; Lower Limb Surgery

Summary: spinal anesthesia is often used for lower limb surgery in elderly. hypotension is a side effect of spinal block. in this study, intravenous ephedrine and phenylephrine will be compared with each other to prevent spinal anesthesia-induced hypotension, which is defined in absolute terms as a systolic blood pressure \< 100 mmhg or in relative terms as a 20% fall of systolic blood pressure from baseline.

randomized single centre clinical randomized study will be performed on 50 participants. the inclusion criteria are participants (age more than 65 years) with proximal femoral fracture scheduled for lower limb surgery under spinal anesthesia. the ethics committee approved this prospective study. informed consent will be taken from individual subjects. participants are randomly allocated into one of the two study groups. group a: participants who will receive intravenous 25 mg of ephedrine added to syringe with 50 ml 0,9% sodium chloride solution during 20 minutes. group b: phenylephrine 5 mg will be added to syringe with 50 ml 0,9% sodium chloride solution, participants will receive intravenous 0,3 mg of phenylephrine during 20 minutes. randomization is achieved with the help of random.org. in order to reduce pain prior to spinal anesthesia an ultrasound-guided fascia iliaca block will be performed using a volume of 30 ml ropivacaine 0,2%. after skin infiltration with 3 ml of lidocaine, a 25g pencan spinal needle will be inserted at the l3-l4 or l4-l5 vertebral interspaces. after aspirating cerebrospinal fluid, participants will receive hyperbaric bupivacaine 0.5% at 0,11 mg/cm according to the participant height. ephedrine and phenylephrine will be given intravenous immediately after injection of bupivacaine. impedance cardiography will be used to measure hemodynamic parameters: cardiac output, stroke volume, cardiac index, stroke index, systemic vascular resistance, systemic vascular resistance index. heart rate, blood pressure and oxygen saturation will also be controlled. all these parameters will be measured and recorded every 5 minutes until 30 minutes after spinal anesthesia. the data will be statistically analyzed.

Eligibility criteria:
inclusion criteria: * elderly (age more than 65 years) * hip fracture scheduled for lower limb surgery under spinal anesthesia * spinal anesthesia exclusion criteria: * contraindications to spinal anesthesia * participant refusal * age less than 65 * bradycardia (heart rate less than 60) * participants unable to give consent or inability to communicate

Keywords: hypotension phenylephrine ephedryne
sexual fonction and discomfort in women after midurethral sling surgery, using ppssq

Conditions: Stress Urinary Incontinence

Summary: evaluation of the sexual quality of life of women who had a sub-urethral sling several years ago, using a recently validated questionnaire: the ppssq (pelvi-perineal surgery sexuality questionnaire). this questionnaire is specifically oriented for women who have undergone surgery for stress urinary incontinence or prolapse. it contains questions specific to post-surgical issues that are not present in other sexual quality of life questionnaires. the questionnaire will also be administered to a group of control women who have not had suburethral sling surgery in order to compare their responses to those of women who have had surgery. the hypothesis is that the placement of a suburethral sling for stress urinary incontinence increases the quality of sexual life of the women.


Eligibility criteria:
inclusion criteria: patient group * women who have received a suburethral sling at chuga in the gynecology or urology departments between january 2015 and june 2020. * women who agreed to complete the ppssq healthy volunteers group * adult women matched on age and menopausal status to the patient group * women who have never undergone surgery for stress urinary incontinence by placing a sub-urethral tape. * women who agreed to complete the ppssq exclusion criteria: patient group * tape removal. * death since surgery. * factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the french language, illiteracy. * absence of perineal sensation. * persons referred to in articles l1121-5 to l1121-8 of the csp. healthy volunteers group * factors that make it impossible to understand the questionnaires: neurological or psychiatric pathology that limits the understanding of the questions, lack of mastery of the french language, illiteracy. * absence of perineal sensation. * persons referred to in articles l1121-5 to l1121-8 of the csp.