Kornimate/medical-research-clean huggingface dataset:
randomized controlled prospective multicenter study primary onlay- mesh after elective median laparotomy in patients with bmi ≥ 27

Conditions: Incisional Hernia; Obesity

Summary: incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. one major risk factor for incisional hernia after a median laparotomy is obesity. the closure technique of midline incisions has remained unchanged since many decades and primarily consists of suturing the linea alba. interest in prevention of incisional hernias with the aid of synthetic mesh is growing and only one large randomized trial is active recruiting patients in germany, netherlands and belgium (prima trial). patients with a bmi of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. this high risk group of patients may benefit from prevention. some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. these studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomy surgery. the goal of this study is to evaluate the effectiveness of incisional hernia prevention after elective median laparotomy in patients with a bmi of more than 27. a randomized controlled trial will be performed comparing the commonly used technique of running suture to close with the aid of a prosthetic onlay mesh. the primary outcome measure will be incisional hernia occurrence. secondary outcome measures will be complications, surgical site infections, post-operative pain and quality of life.


Eligibility criteria:
inclusion criteria: * every elective midline laparotomy for patients with a bmi of more than 27. signed informed consent exclusion criteria: * age \< 18 years * emergency procedure * inclusion in other trials * previous midline incision * life expectancy less than 24 months * pregnant women * immune suppression therapy within 2 weeks before surgery

Keywords: body mass index
eating disorders and autism spectrum disorders

Conditions: Eating Disorders

Summary: this is an observational study where patients with eating disorders (ed) are compared with healthy controls without eating disorder (hc) regarding eating disorders features and autism spectrum features. also patients will be reassessed after 5 years.

the first author who suggested that eating disorders (ead) and autism spectrum disorders (asd) share common features was christopher gilberg in 1980. currently it is known that patients with ed have social impairment, which is also a risk marker to develop ed, eating disturbances are overrepresented in asd, ed and asd have common behavioural features such as rigidity, perfectionism, and harm avoidance; and common cognitive profiles such as inflexibility, high attention to detail, high scores in systemizing profiles and poor results in advanced theory of mind tests. this relationship is also supported by similar neural phenotypes such as atypical structure and function in social brain regions found in both disorders. the aim of the present study is to explore the relationship between ed and asd traits in a sample of spanish participants diagnosed with an, bulimia nervosa (bn), binge-eating disorder (bed) and other eating disorders (oed). specifically, the investigators aim to explore possible differences within the different ed and its particular transdiagnostic features in association with autistic traits. the sample will consist of 90 patients with ed and 45 healthy controls (hc) without any current or lifetime history of mental disorder, both groups will be compared regarding ed and asd features. also patients will be reassessed in a 5 year follow up.

Eligibility criteria:
inclusion criteria: * being diagnosed with ed exclusion criteria: * language or intellectual impairment

Keywords: eating disorders autism spectrum disorders
comparative diagnostic study between multislice computed tomography (msct) and stress echography in coronarin patients.

Conditions: Chest Pain

Summary: the aim of this study is to define the best prognostic strategy for patients presenting suspected acute coronary syndrome, between msct and stress echocardiography.

patients presenting with a suspected acute coronary syndrome is based on the interrogation, the realization of an electrocardiogram (ecg) and 2 dosages of the cardiac troponin at some hours of interval. however, the ecg and the troponin are frequently normal and this does not absolutely eliminate the diagnosis. in that case, it is at present recommended to practise an effort ecg or a stress imaging, such as echocardiography. several studies estimated the diagnostic exactness of stress echography for patients presenting a recent chest pain without modification of the ecg nor a rise of the troponin with a sensibility from 71 to 86% and a specificity from 91 to 98%. recently, several teams estimated the interest of multislice computed tomography (msct) in the same population. the msct sensibility reported by 2 teams is promising because was found between 91 and 100%. on the other hand, the specificity was appreciably less good : between 76 and 82%. the negative predictive value to msct was excellent : between 97 and 100%.the aim of this work is to compare the diagnostic exactness between stress echography and msct for patients presenting with a suspected acute coronary syndrome without modification of the ecg nor rise of the troponin. it is about a prospective monocentric diagnostic study concerning 400 patients. the primary end point is the proportion report of true positives in msct with regard to stress echocardiography (the main diagnosis is the coronarography). the secondary end points include the proportion of false positives, the non interpretable or non contributory examination rate and especially the proportion of unwanted events in 6 months for the negative patients in both examinations according to a combined criteria including death, myocardial infraction (mi), percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or readmission for chest pain with coronarography visualizing a stenosis greater than 50 %.

Eligibility criteria:
inclusion criteria: * chest pain \< 24 hours * normal ecg * normal troponin i exclusion criteria: * ecg evolution * troponin i evolution * hemodynamic instability * rhythmic instability * allergy to iodized contrast products * creatinin \> 150 micromol/l * venous capital absence * auricular fibrillation

Keywords: msct echocardiography coronarography acute coronary syndrome without st segment elevation normal ecg normal troponin acute
can oral vitamin b12 and folate supplementation preserve cognitive function of patients with early dementia?

Conditions: Dementia

Summary: background: vitamin b12 and folate are essential to brain health. sub optimal status of vitamin b12 and folate leads to elevation of plasma homocysteine concentration, which is associated with dementia. vitamin b12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study. objective: to determine the effectiveness of vitamin b12 and folate supplementation in preserving cognitive function of subjects with early dementia

after stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. the primary outcome is mattis dementia rating scale. the secondary outcomes are mini mental state examination, neuropsychiatric inventory, and cornell scale for depression in dementia. these measurements will be performed at baseline and every six months for 24 months. fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.

Eligibility criteria:
inclusion criteria: * dementia of alzheimer's or vascular type * early dementia defined by clinical dementia rating of 1. exclusion criteria: * lives alone * significant communication problems * significant co-existing diseases * blood tests:vitamin b12\ 250 mol/l, hypothyroidism and syphilis
prehabilitation for colorectal cancer patients with low functional capacity and malnutrition

Conditions: Prehabilitation; Malnutrition; Physical Functional Performance

Summary: despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6mwd), a prognostic cut-point. compared to the patients that attained \>400m 6mwd preoperatively, twice as many of \<400m patients were malnourished. malnutrition has long been associated with worse functioning (e.g., physical, immune). the investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. correction of malnutrition alone might thus be sufficient to achieve a 400m 6mwd before surgery and improve patient outcomes.

the investigators propose a randomized controlled trial of nutrition prehabilitation alone vs nutrition prehabilitation with supportive exercise in patients with malnutrition and 6mwd \<400m before elective colorectal surgery. the primary objective, and therapeutic target, will be achievement of minimal clinical important difference for the 6mwd (14m for within group comparisons and 19m between groups). ability to adhere to the interventions will be monitored. the findings of this study will guide optimal treatment for this vulnerable population by exploring the role of nutrition alone vs. nutrition with exercise to optimize surgical outcomes.

Eligibility criteria:
inclusion criteria: * patients aged 65 years and older; * patients with cancer scheduled for primary colorectal resection; * patients with 6mwd at baseline less than 400 m; * patients with patient-generated subjective-global assessment (malnutrition assessment) score equal or greater than 9. exclusion criteria: * patients with history of premorbid conditions that contraindicate exercise including dementia, -parkinson's disease or previous stroke with paresis; * metastatic cancer; * patients who do not speak english or french and cannot be accompanied by someone who speaks english or french;
a phase 3 substudy to evaluate executive function in adults with pku who are participating in the phase 3 study, 165-302

Conditions: Phenylketonuria

Summary: a phase 3 substudy to evaluate executive function in adults with phenylketonuria who are participating in the phase 3 study, 165-302. approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with pku will be enrolled.

study 165-303, is a phase 3 substudy enrolling approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with pku who are participating in the phase 3 study, 165-302. per the 165-303 protocol, the investigator does not assign a specific intervention to the study participants. in accordance with the protocol for study 165-303, subjects were asked to perform selected set of three tasks from the cantab tool (rapid visual processing \[rvp\], spatial working memory \[swm\], and stop signal task \[sst\]) to assess executive function and each subject's self perception of their current state was measured using a subject global assessment questionnaire that contains seven questions about current state perception of attention, energy level, tiredness, confusion, sadness, anger and tension. the time points for administering the above tools are as follows, which coincide with time points in part 2 and part 4 of study 165-302: screening (entry into part 2 165-302 day 1 of week 1), baseline visit (part 2 week 8), and 3 additional study visits at different time points in the part 4 of 165-302 study.

Eligibility criteria:
inclusion criteria: * are currently participating in part 1 of study 165-302 and meet the criteria for participation in part 2 of 165-302 * are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures. * have the ability to complete the cantab and subject global assessment. * are willing and able to comply with all study procedures. exclusion criteria: * any condition that, in the view of the investigator, places the subject at high risk of poor compliance or terminating early from the study

Keywords: pku peg-pal pegvaliase bmn 165 rav-pal peg prism 302 prism 303 biomarin 165-302
single versus multiple deployment of metallic stents for inoperable malignant hilar biliary obstruction

Conditions: Klatskin Tumor

Summary: in bismuth ii-iv hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. however, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. the optimal endoscopic management strategy is contentious. the investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

in bismuth ii-iv hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. however, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. the optimal endoscopic management strategy is contentious. the investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents. first as an unilateral or bilateral stent will be deployed according to criteria. in bilateral group, stent-in-stent or side-by-side deployment will be included.

Eligibility criteria:
inclusion criteria: * age \> 18 years * inoperable hilar malignancy exclusion criteria: * age under 18 years * uncontrolled coagulopathy * inability to provide informed consent

Keywords: hilar tumor metal stent single multiple
radio-frequency (rf)-based plasma micro-tenotomy for the treatment of shoulder impingement syndrome

Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders

Summary: the purpose of this study is to determine whether radio-frequency (rf)-based plasma micro-tenotomy has a positive effective for the treatment of shoulder impingement syndrome with cuff tendinosis. eighty patients with impingement syndrome and cuff tendinosis that treated arthroscopic were enrolled in the study. patients were randomly assigned to receive either arthroscopic subacromial decompression alone (asd group, n=40) or arthroscopic subacromial decompression combined with rf-based plasma micro-tenotomy (rf group, n=40). clinical outcome data including vas(visual analogue scale) pain score, shoulder range of motion (rom), ases(american shoulder and elbow surgeons) score, ucla(university of california, los angeles) score, constant-murley score and sst(simple shoulder test) score were recorded preoperatively and at postoperative 3-week, 6-week, 3-month, 6-month and 1-year.


Eligibility criteria:
inclusion criteria: 1. a skeletally mature patient who agreed to participate in the study 2. shoulder impingement syndrome was diagnosed by one senior surgeon (cyj) and without any sign of rotator cuff tear both on pre-operative mri or intra-operative arthroscopic view 3. supraspinatous tendinosis was confirmed on preoperative mri 4. the symptoms were not relieved by a standardized conservative treatment regime 5. patient underwent standard arthroscopic subacromial decompression surgery. exclusion criteria: 1. any concomitant partial or full-thickness rotator cuff tear verified both on pre-operative mri or intra-operative finding 2. concomitant biceps lesions or internal impingement 3. any history of surgical treatment on the same shoulder.

Keywords: arthroscopic subacromial decompression bipolar radiofrequency tendon debridement shoulder surgery
a study to evaluate the safety, tolerability, and efficacy of odanacatib (mk-0822) in postmenopausal women previously treated with a bisphosphonate (mk-0822-042)

Conditions: Osteoporosis

Summary: the study will evaluate the both the efficacy of odanacatib on bone mineral density (bmd) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. the primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.


Eligibility criteria:
inclusion criteria: * has been postmenopausal for at least 5 years * has taken or is taking alendronate * agrees not to use medications for osteoporosis other than what is provided by the study exclusion criteria: * has a history or evidence of hip fracture * has a history of cancer within 5 years of screening, except certain skin or cervical cancers. * has active parathyroid disease * has a history of thyroid disease not adequately controlled by medication * is taking anti-seizure medication and has abnormal calcium metabolism * has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
safety and tolerability of hcbe-11 in subjects with advanced solid tumors

Conditions: Tumors

Summary: this is a phase i, open-label, dose-escalation study on subjects with advanced solid tumors. this is the first study of hcbe-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. the study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.


Eligibility criteria:
inclusion criteria: * relapsed or refractory solid tumors not curable with standard therapy. * at least one measurable lesion * ecog performance status less than or equal to 2 * acceptable hematologic status * albumin greater than or equal to 2.5 g/dl * normal calculated glomerular filtration rate (gfr) * acceptable liver function exclusion criteria: * uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to study day * known history of hepatitis b or c, or hiv infection * clinically significant effusions, including pericardial, pleural, and ascites * serious non-malignant disease * central nervous system (cns) metastatic involvement except where the disease has been successfully treated * investigational therapies within 4 weeks of study day 1 * radiation therapy of tumors to be followed for this study * chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to study day 1 * current grade 3 or 4 neurological toxicity * concurrent anti-neoplastic therapy and/or steroids

Keywords: monoclonal antibody advanced solid tumors tumors hcbe-11
results comparison of cervical cancer early detection using cerviray with via test

Conditions: Cervical Cancer

Summary: cervical cancer, primarily caused by human papilloma virus (hpv), is a significant global health concern, ranking as the fourth most common cancer in women worldwide. in indonesia, it stands as the second most frequent cancer among women. this study investigates the performance of cerviray® ai and cerviray® ai evaluation, an artificial intelligence (ai) technology for diagnosing cervical cancer, aiming to compare its sensitivity, specificity, positive predictive value (ppv), and area under the receiver operating characteristic curve (auc roc) with the visual inspection with acetic acid (via) test.

the study involved 44 patients from various health centers in west java province. cerviray® ai, cerviray® ai evaluation, and via tests were administered to high-risk women of childbearing age.

Eligibility criteria:
inclusion criteria: * high-risk women of childbearing age who would be screened for cervical cancer (by cerviray ai examination, cerviray ai evaluation, and via test) at 1 clinic and other 4 health centers exclusion criteria: * incomplete data * patient refusing to be examined * patient refusing to participate in the study

Keywords: cervical cancer cerviray via test early detection
the role of physical activity for acute exacerbations of copd

Conditions: COPD

Summary: the investigators plan to study the association between physical activity, malnutrition and sarcopenia and the occurrence of acute exacerbations of copd / the evolution of the copd assessment test (cat) over 1 year in a telehealthcare cohort of patients with copd. the investigators hypothesize that malnutrition and/or sarcopenia at baseline and a decline in the fat-free mass index over time is associated with an increased rate of acute exacerbations of copd and an increased cat score meaning a higher risk for mortality, morbidity and impairment of quality of life.


Eligibility criteria:
inclusion criteria: * copd gold stage b or higher * written informed consent exclusion criteria: * inability to provide written informed consent * insufficient knowledge of the trial language
artemether-lumefantrine (al) versus artesunate + amodiaquine (asaq) for the treatment of uncomplicated falciparum malaria in burkina faso

Conditions: Uncomplicated P. Falciparum Malaria in Children

Summary: several countries in africa have changed their first-line treatment for uncomplicated malaria to an act. burkina faso has changed its policy to artemether-lumefantrine (al) and artesunate-amodiaquine (aq+as). however, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. thus, this study aims at investigating the effectiveness of aq+as and al, when given to children with uncomplicated malaria in burkina faso.


Eligibility criteria:
inclusion criteria: * weight \> 5 kg; * monoinfection with p. falciparum and a parasitaemia of 2,000-200,000 parasites /µl; * fever (axillary temperature ≥37.5 °c) or history of fever in the preceding 24 hours; * haemoglobin value above 5.0 g/dl; * absence of febrile conditions caused by diseases other than malaria. exclusion criteria: * danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand; * signs of severe malaria (who 2000); * mixed malaria infection; * severe malnutrition; * other underlying diseases (cardiac, renal, hepatic diseases); * history of allergy to study drugs;

Keywords: uncomplicated malaria