Kornimate/medical-research-clean huggingface dataset:
impact of preoperative bathing on post caesarean section surgical site infection

Conditions: Cesarean Wound Disruption With Postnatal Complication

Summary: surgical site infection (ssi) is the commonest hospital-acquired infection globally, and prevalence is much higher in the low-income countries. caesarean delivery carries a 5-20 fold risk for developing postpartum sepsis. ssis cause significant morbidity, prolonged hospitalization and mortality. simple and inexpensive interventions like preoperative bathing need to be studied, to assess their impact on surgical site infection rates.

caesarean delivery is the single-most important risk factor for postpartum pregnancy associated infections carrying a 5 to 20-fold increase in the risk of developing sepsis. research done in mrrh showed a post-surgery wound sepsis prevalence of 82% on all surgical wards in the hospital and the prevalence of post caesarean section wound infection at mrrh is 15.5%. at mrrh, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization and mortality. ssi is associated with a mortality rate of 3%, and 75% of ssi associated deaths are directly attributable to the ssis. universal practices like preoperative bathing of patients are currently not being practiced at mrrh and thus their impact on reducing the burden can only be speculated upon. the aim of this study was to assess the impact of preoperative bathing with chloroxylenol antiseptic on the incidence of post caesarean section surgical site infection.

Eligibility criteria:
inclusion criteria: * all mother scheduled for delivery by emergency c/s at mrrh during the study period. exclusion criteria: * women who declined to consent. * women with obvious evidence of infection, like fever, foul-smelling liquor, or those already on antibiotics for reasons other than preoperative prophylaxis. * women in whom delivery was indicated to occur within less than 30 minutes, like in fetal distress, obstructed labor, pulsatile cord prolapse, or ruptured uterus. * women who could not communicate and give information for the study and those who do not have a working telephone contact.

Keywords: surgical site infection
efficacy and safety of induction chemotherapy for olfactory neuroblastoma (esicon)

Conditions: Olfactory Neuroblastoma

Summary: the goal of this clinical trial is to learn about the induction chemotherapy efficacy in olfactory neuroblastoma. the main question it aims to answer is: wether olfactory neuroblastoma patients with different pathology subtypes apply to different induction chemotherapy schemes. participants will be treated with different chemotherapy schemes, to evaluate the tumor remission rate and long term survival.

this study included patients with olfactory neuroblastoma who were pathologically diagnosed and met the criteria. according to molecular profiles, two different induction chemotherapy schemes were used to evaluate the tumor remission rate.

Eligibility criteria:
inclusion criteria: 1. patients with pathologically confirmed olfactory neuroblastoma; 2. age ≥ 18 years old; 3. dulguerov stage t2-t4; 4. patients who signed the informed consent forms; 5. no distant metastasis. exclusion criteria: 1. patients with uncontrolled concurrent diseases that the researchers believe will interfere with treatment; 2. any situation in which the patient may interfere with the compliance or safety during the study; 3. severe neurological or mental illness, including dementia and seizures; 4. uncontrolled active infection; 5. pregnant or lactating women; 6. persons without personal freedom and independent capacity for civil conduct; 7. other situations that are not suitable for joining the group.

Keywords: induction chemotherapy
formative research for an hiv videogame for young black women

Conditions: HIV Prevention; STI Prevention

Summary: as part of yale's play2prevent (www.play2prevent.org) program to develop videogame-based interventions targeting risk reduction and prevention in youth and young adults, this study is designed to develop a paper prototype and intervention design manual of an online social-network game, one night stan, with the goal of risk reduction and hiv/sti prevention in young black women. the ultimate plan is to incorporate focus group participants input and feedback into the development of a conceptual model, intervention manual, and videogame intervention prototype. this prototype will then be tested using 20 participants and will utilize a pre-post design to evaluate the effectiveness of the program.

the specific aims of this study are to: develop an online social network game for hiv/sti risk reduction and prevention by conducting a first set of focus groups with a total of 25 participants (5 focus groups with 5 participants each) in order to better understand preferences for online social network and gaming platforms, characteristics and design. these collected data, established theoretical constructs, and the literature will be harnessed to develop a conceptual model for hiv/sti risk reduction and prevention in this specific population of women. from the data collected and the new conceptual model, an intervention manual will be created that will incorporate a culturally and socially-tailored online social network game intervention paper prototype and design manual. in an iterative fashion, a second series of focus groups will be conducted (5 groups with 5 participants each for a total of 25 participants) to refine the intervention. to pilot test the prototype intervention we will determine, in a pre-post design: (a) the intervention's acceptability and feasibility based on self-report data on the game experience and (b) preliminary evidence of the efficacy of the intervention collecting data on 1) hiv/sti knowledge 2) intentions/attitudes regarding condom use and hiv/sti partner testing 3) self-efficacy to insist on condom use and hiv/sti partner testing 4) self-efficacy and beliefs related to sexual risk behaviors, 4) perceived social norms, and 5) behaviors related to condom use and partner hiv/sti testing. the focus of this registration record will be the participants and collected outcomes used to assess the prototype of the social network game. assessments will be conducted at baseline, 2 weeks after playing the game and at 4 weeks post follow up.

Eligibility criteria:
inclusion criteria: * african-american race * female * ages 18 to 24 yeats exclusion criteria: * failure to meet all inclusion criteria will exclude individuals from participation in the study
a study of crv431 dosed once daily in nash induced f2 and f3 subjects

Conditions: NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; NAFLD - Nonalcoholic Fatty Liver Disease

Summary: this is a randomized, single-blind, placebo-controlled, once daily (qd) dose study of crv431 in presumed nash f2/f3 subjects.

this is a randomized, single-blind, placebo-controlled, once daily (qd) dose study of crv431 in presumed nash f2/f3 subjects. study will evaluate the safety and tolerability of a once daily 75mg dose and 225mg of crv431 compared to placebo over 28 days of dosing. pharmacokinetic parameters of crv431 and its major metabolites and fraction unbound will also be evaluated. non-invasive antifibrotic bio-markers will be collected and quantified from presumed nash f2/f3 subjects dosed with 75mg crv431 or placebo.

Eligibility criteria:
key inclusion criteria: * male or female between 18 and 75 years of age (inclusive). * capable of giving written informed consent and able to effectively communicate with the investigator and study personnel. * presumed f2/f3 nash to include: ast \>20 iu/l, pro-c3 \>15.5 ng/ml, enhanced liver fibrosis (elf) score \>9.8, and fibroscan \>8.5 kpa values. key exclusion criteria: * pregnant or breastfeeding or planning to become pregnant during the study period. * known allergy to crv431, cyclosporine, or any of their inactive ingredients. * positive test for hepatitis b surface antigen (hbsag), hepatitis c virus antibodies (hcvab) or human immunodeficiency virus antibodies (hivab). * well documented causes of chronic liver disease according to standard diagnostic procedures to include any history or presence of decompensated cirrhosis. * subjects with a platelet count \<150,000/ml. * subjects with hemoglobin a1c(hba1c) \>9.5%. * weight loss of more than 5% within 3 months prior to randomization. * subjects with a blood pressure to include a systolic pressure \>150 or a diastolic pressure \>90. * at screening, an estimated glomerular filtration rate (egfr) \ g2. * subjects with a history of organ transplantation. corneal transplantation will be allowed.

Keywords: anti-fibrotic
clinical assessment of spinal muscular atrophy type ii and iii (sma europe)

Conditions: Spinal Muscular Atrophy

Summary: the aim of this project is to establish a network of clinical teams including the major neuromuscular centers in europe. we plan to work together to find the best common outcome measures for the following multicenter therapeutic trials.

16 patients (6 ambulant and 10 non ambulant), affected by type ii and type iii sma will be enrolled and assessed at baseline and 6 and 12 months later. non ambulant patients will be assessed using the modified version of the hammersmith motor functional scale while ambulant patients will be assessed using the extended module of the hammersmith motor functional scale and timed items, the 6 minute walk and a step activity monitor. all patients will also be assessed using the motor function measure (mfm), that covers the whole range of activities for both ambulant and non ambulant patients. all measures will undergo a process of validation including inter observer reliability. this information will be most valuable for any future trial and will make the groups involved ready to participate to future collaborative studies saving a lot of time on the preliminary aspects (validation, reliability, training) that will be fulfilled by the present study. the study will also provide natural history data for a 12 month period on patients with sma ii and iii.

Eligibility criteria:
inclusion criteria for ambulant patients: * age between 30 months and 24 years * documented sma diagnosis by genetic tests; each should also have the determination of the smn2 copy number * able to walk 10 meters without support * subject who signed an informed consent- subject affiliated to a social security system inclusion criteria non ambulant patients: * documented diagnosis of sma by genetic tests * not able to walk 10 meters without support * subject affiliated to a social security system * subject who signed an informed consent exclusion criteria: * patient who are currently involved in other clinical trials * severe intellectual impairment limiting the comprehension of the demanded tasks * acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion * chronic neurologic (besides sma), inflammatory, infectious, endocrine, orthopedic disease which are not a natural consequence of sma * spinal surgery scheduled 6 months before or within 12 months after enrollment * pregnant women

Keywords: outcome measures spinal muscular atrophy
japan study of distal evaluation of functional significance of intra-arterial stenosis narrowing effect

Conditions: Coronary Artery Disease

Summary: to investigate whether instantaneous wave-free ratio(ifr)/fractional flow reserve(ffr) guided treatment strategy makes the postulated treatment strategy by coronary angiogram(cag) guide change and to analyze the cost-effectiveness of its dual diagnosis. to investigate difference between syntax score evaluated cag and functional syntax score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.


Eligibility criteria:
inclusion criteria: * age\>=20 years old. * patient who can understand informed consent of the clinical study and signed the consent. * patient who is adaptable to cag and/or coronary revascularization * patient who has evaluated stenotic lesion (stenosis\>50% in visual judgment) by cag at main epicardial vessel and its branch or who suspected to have it. exclusion criteria: * patient with known contraindications to adenosine triphosphate(atp) and/or papaverine hydrochloride * target vessel diameter\<=2.0mm * lesion with chronic total occlusion(cto) (registration allowed if other branch has stenosis more than 50% in visual judgment) * patient with temporary/permanent artificial pacemaker implantation, left bundle branch block, second-degree and third-degree atrioventricular block. * acute myocardial infarction(ami) patient * patient who is disqualified for ffr and coronary revascularization by the investigator. * lesion is disqualified for percutaneous coronary intervention(pci) by the investigator. * patient who has critical valvular disease of heart. (moderate or severe aortic valve stenosis(as)/aortic regurgitation(ar)/mitral stenosis(ms)/mitral regurgitation(mr)） * patient with a prior coronary artery bypass graft(cabg) on target vessel. * patient with severe renal dysfunction. (serum creatinine\>=2.0mg/dl) * patient on hemodialysis. * body weight\>=200kg * patient who needs ventricular assist device to ensure hemodynamic stability (heart rate\<50/min, sbp\<90mmhg) * patient who expects to live less than 2 years at the registration * patient with contraindications to an antithrombotic therapy or an anticoagulant therapy. * patient who is poor compliance with drug treatment. * patient who is allergic to contrast agent. * left ventricular ejection fraction(lvef)\>=30% * patient who has the history of pci with drug-eluting stent(des) in recent 3 months before registration. * patient who has the history of pci with bare metal stent(bms) or plain old balloon atherectomy(poba) in recent 1 year before registration. * patient who has possibility of pregnancy, under breast-feeding and positive pregnancy test in 14days prior to the pci. * patients with inadequacy to join this clinical study. * patient who has been enrolled any other clinical study.

Keywords: ifr ffr medical economy physiological assessment syntax score
knee osteoarthritis in the region of norrbotten

Conditions: Osteoarthritis; Knee Injuries; Knee Osteoarthritis; Tibial Plateau Fractures; Tibial Fractures; Patient Satisfaction; Quality of Life; Complication of Treatment

Summary: the goal of this observational study is to assess the prevalence of radiographic knee osteoarthritis and to report medium and long term functional outcomes secondary to tibia plateau fractures. the second aim was to investigate whether there were any risk factors associated with these outcomes.

1. the study population consists of patients from the swedish region of norrbotten (northern part of sweden) who had undergone tpf between the years of 2001 and 2015. 2. all patients are evaluated radiographically. 3. condition-specific scores are assessed using the knee injury and osteoarthritis outcome score (koos). general health related quality of life are assessed by the euroqol 5-dimension 5-level (eq-5d-5l) tool. 4. all patients are examined clinically. 5. the relationship between the development of radiographic oa in patients who had undergone tpf and such potential factors as gender, age, body mass index (bmi), fracture pattern or method of fracture treatment is being assessed. 6. the data from the swedish fracture register and the swedish arthroplasty register are used in order to follow the long-term results.

Eligibility criteria:
inclusion criteria: * patients from the region of norrbotten (northern part of sweden) who underwent tibial plateau fracture between the years of 2001 and 2015 exclusion criteria: * death without bilateral weighted x-ray minimum 5 years post injury * open growth plate in distal femur and/or proximal tibia * extraarticular or isolated eminentia fracture * oa prior to injury * having a rheumatic disorder involving joints * earlier and/or later severe injury to the index knee * having cognitive disorders disqualifying from the study

Keywords: osteoarthritis knee tibial plateau fracture outcome arthroplasty
residual embolism evaluated with single photon emission computed tomography

Conditions: Pulmonary Circulation Obstruction

Summary: major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (pe). these improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of chronic thrombo-embolic disease (cted). in most of the situations, it is due to a residual pulmonary vascular obstruction (rpvo) which can be assessed by pulmonary scintigraphy.

planar ventilation/perfusion (v/q) scintigraphy is the gold standard, but for several months, v/q single photon emission computed tomography (spect) is recommended in the guidelines. the aim of this study is to evaluate the performances of various spect protocols to quantified rpvo and compared to planar scintigraphy to evaluate the rpvo.

Eligibility criteria:
inclusion criteria: * patient addressed to nuclear medicine department of saint-etienne public hospital for v/q pulmonary spect-ct assess to rule out perfusion obstruction, admitted for a suspicion of pulmonary hypertension (ph), or a persistent dyspnea after pe * patient affiliated ou beneficiary of social security. exclusion criteria: * pregnant patient. * patient addressed to nuclear medicine department for acute pulmonary embolism. * impossibility of the entire protocol acquisitions realization.

Keywords: scintigraphy
psg and neuroendocrine hormones in subjective cognitive impaired patients with transformed migraine

Conditions: Migraine

Summary: transformed migraine is the most common and challenging subtype of chronic daily headache disorders35. patients with transformed migraine often report an evolutionary process that occurs over months or years in which headaches increase in frequency, change characteristics and ultimately result in patterns of daily or near-daily headaches resembling a mixture of tension-type headache and migraine.

the present study aimed to investigate the presence and frequency of cognitive affection in patients with transformed migraines, as well as to analyze the association of cognitive affection with clinical features and headache impact, anxiety, depression, and quality of sleep.

Eligibility criteria:
inclusion criteria: -patients included were adults with clinically confirmed of chronic migraine exclusion criteria: * primary headache disorder other than migraine * secondary headache disorders other than medication-overuse headache or unclassified headache, or * aged under 18 years or older than 65 years

Keywords: migraine
a mannequin study to assess various cpr training methods using a student population

Conditions: Cardiac Arrest; Heart Disease

Summary: prompt delivery of cardiopulmonary resuscitation (cpr) can double a victims chance of survival from cardiac arrest (ca), yet it is provided in less than 1/3 of witnessed events. studies indicate that video-based education methods can effectively train bystanders in cpr. using the education and evaluation methods of an existing in-hospital training program, the investigators will assess the cpr skills of students taught with video-only methods, with and without psychomotor skills practice, and compare them to those using a video self-instruction (vsi) kit.

the long term goal of our work is to implement real world cpr training strategies that maximize resuscitation skill retention, and promote willingness to act while addressing major barriers to training including time and cost. to accomplish this, the study team will train student volunteers from the university of pennsylvania using one of three methods: 1) a video-only method with no psychomotor skill practice, 2) a video-only method with psychomotor skill practice on a household object or 3) a video self-instruction (vsi) kit. volunteers will be young, healthy students from the university of pennsylvania with no cpr training within the last 24 months. the investigators will use the american heart association's cpr anytime video self-instruction kit which comes equipped with a dvd and inflatable manikin. for the groups receiving the video-only methods, the investigators will remove the inflatable manikin and train the subjects with the dvd. the investigators will randomize the participants to one of the video-only methods or to the vsi kit method of training when they are scheduled for training. immediately following the training, the investigators will conduct a cpr skills test to measure the effectiveness of the training method. three (3) to twelve (12) months post-training the investigators will schedule and conduct an in-person interview with subjects. as part of the interview, subjects will be asked to complete a survey measuring their comfort level and willingness to use their cpr skills. subjects will also be asked to complete another cpr skills test.

Eligibility criteria:
inclusion criteria: * must be able to complete 25-30 minutes of moderate physical activity exclusion criteria: * cpr training within the past 24 months

Keywords: cardiopulmonary resuscitation education
vegf trap-eye: investigation of efficacy and safety in chinese subjects with wet amd (age-related macular degeneration)

Conditions: Macular Degeneration

Summary: this study will assess the efficacy and safety of intravitreally (ivt), i.e. directly into the eye administered vegf trap-eye compared with photodynamic therapy (pdt) on visual function in chinese subjects with age-related neovascular or "wet" age-related macular degeneration. subjects will be randomized in a 3:1 ratio to either receive vegf trap-eye or pdt. both treatment groups will receive the other treatment as a sham procedure.

adverse events collection will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * men and women ≥ 50 years of age. * active predominantly classic subfoveal choroidal neovascularization (cnv) lesions secondary to wamd (wet age-related macular degeneration) * bcva (best corrected visual acuity) of 20/40 to 20/320 in the study eye exclusion criteria: * only one functional eye * presence of cnv with an origin other than wamd * any prior ocular or systemic treatment or surgery for wamd, except dietary supplements or vitamins
reach detroit partnership family intervention

Conditions: Diabetes Mellitus

Summary: the objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (rct) methods and to explore and document effective processes and protocols for rct methods in these communities. the investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. as a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * had physician-diagnosed type 2 diabetes * self-identified as african american or latino/hispanic * lived in the targeted zip codes. exclusion criteria: * individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure

Keywords: randomized controlled trial