Kornimate/medical-research-clean huggingface dataset:
gestational diabetes in uganda and india improving screening and self-management

Conditions: Gestational Diabetes

Summary: this trial will evaluate a package of three interconnected educational/behavioural interventions aimed at: a) improving knowledge and skills of gdm guidelines and skills of health providers; b) raising awareness of importance of gdm screening among pregnant women and their families; and c) improving confidence and skills in self-management among those diagnosed with gdm. the interventions will be delivered through the medium of film as they are low-cost and scalable, and are particularly suitable for people who are not very literate, making them ideal for low- and middle-income countries (lmics). the research will be carried out in uganda (entebbe) and india (bengaluru). a careful contextual analysis will precede the development of a culturally-tailored film-based intervention for each setting, which will be iteratively refined using qualitative research methods till it is fit for purpose. the effectiveness of the intervention will be evaluated in independent cluster randomised trials, involving \~10,000 pregnant women across 30 maternity units at each site. the films will be made available in the intervention arm facilities: for viewing by doctors and nurses at their meetings, for continual screening in waiting areas of antenatal clinics, and during group education sessions (and personal mobile use) for gdm patients. where video/projection facilities are unavailable, small low-cost projectors will be made available. control arms will follow usual care practices. the principal research question is whether a low-cost educational/behavioural intervention delivered through a package of culturally-tailored films can provide scalable improvements in timely detection and management of gdm. this will be evaluated through assessing three endpoints: a) detection of gdm at 32 weeks of; b) glycaemic control (fasting glucose) in women with gdm at \~34 weeks of pregnancy; and c) adverse perinatal outcomes associated with gdm. interviews will be conducted with women and health providers to help understand how and why the intervention may be (or may not be) successful. the ultimate aim of the project is to contribute to scientific evidence underpinning the use of films in cost-effectively scaling up behavioural interventions in low literacy settings.


Eligibility criteria:
inclusion criteria: * pregnant women aged 18 or over attending for antenatal care at participating health facilities. * pregnant women willing and able to give informed consent. exclusion criteria: * pregnant women \<18 years * no informed consent

Keywords: pregnancy gestational diabetes india uganda cluster randomized trial
save- oral antibiotics for treatment of vertebral osteomyelitis

Conditions: Osteomyelitis; Vertebra

Summary: background the current danish national guideline for treatment of pyogenic vertebral osteomyelitis (pvo) recommends 6 weeks antibiotic (ab) treatment, with a 2-week intravenous (iv) ab lead-in followed by 4 weeks oral ab for uncomplicated pvo, and 12 weeks ab treatment with a 2-4-week iv ab lead-in followed by 8 weeks oral ab for complicated pvo. the primary objective of the current study is to investigate whether shortening the duration of iv ab to one week for both complicated and uncomplicated pvo is non-inferior to the current danish national guideline.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. diagnosed with pvo by a physician based on clinical symptoms and findings consistent with pvo in combination with diagnostic imaging (mri, pet/ct or pet/mri) 3. the physician responsible for the patient decides to treat the patient for pvo 4. at time of randomization crp has decreased to \< 75% of peak value or to \< 20 mg/l 5. at the time of randomization patient has received maximum 7 days of appropriate iv ab for pvo - exclusion criteria: 1. previous episodes of pvo within the past 24 months 2. spinal implants inserted prior to current episode of pvo 3. hypersensitivity to an ab intended for use in the patient and no alternative drugs available. 4. oral abs not possible due to suspicion of reduced absorption 5. oral abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen 6. identification of fungus, mold, tb, brucella, actinomyces, nocardia and p. aeruginosa as etiology 7. severe immunocompromise defined as primary immunodeficiencies, uncontrolled hiv/aids, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone \>=20 mg daily \>14 days 8. verified or expected reduced compliance (for example iv drug use) 9. pregnancy 10. breastfeeding 11. women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period. 12. patients not capable of providing informed consent at time of screening for inclusion 13. diagnosed or suspected concomitant or unrelated infections necessitating iv ab therapy beyond 7 days of duration at the time of randomization -
night myopia and dark focus of accommodation

Conditions: Dark Focus of Accommodation

Summary: shifts in accommodation at decreasing luminance levels are considered as principle cause for night myopia. previous studies with laser optometers quantified the dark focus of accommodation up to 3 d. in addition to the measurement of dark focus, the aim of this study was to investigate the influence of an imaginary target at finite distances on the state of accommodation at scotopic luminance.

accommodation was measured by using an open-field autorefractor (wam 5500, grand seiko). full corrected right eyes of 39 subjects aged from 18 to 40 years were investigated in this randomized, cross-sectional study. accommodation measurements in photopic luminance were taken for 6 m of empty field and for optotype fixation at 2 m, 1 m and 0.5 m. at scotopic luminance, dark focus of accommodation was examined directly after darkening and after 10 min of dark adaptation. after adaptation, subjects had to visualize imaginary targets in the four distances while accommodation was measured.

Eligibility criteria:
inclusion criteria: * age 18 - 44 * visual acuity at least 0.8 (5/6) exclusion criteria: * medication with an impact on the visual system * visual disease or disease with an impact on the visual system * pregnancy or other hormonal variances * drug usage * overfatigue at the period of investigation * mental handicap

Keywords: accommodation dark focus night myopia
early feasibility of the mitralign percutaneous tricuspid valve annuloplasty system (ptvas) also known as trialign™.

Conditions: Chronic Symptomatic Functional Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Heart Valve Disease

Summary: the purpose of this study is to assess the early safety and performance of the mitralign percutaneous tricuspid valve annuloplasty system (ptvas) for the treatment of symptomatic chronic functional tricuspid regurgitation (ftr). the procedure will be performed with the ptvas device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have ftr with a minimum of moderate tricuspid regurgitation.

a prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. the study will include up to 30 subjects from up to 6 sites. follow-up evaluations will be conducted through 2-years post implantation.

Eligibility criteria:
inclusion criteria: * chronic functional tricuspid regurgitation (ftr) with a minimum of moderate tricuspid regurgitation; * ≥18 and ≤85 years old; * nyha ii - iv; * symptomatic despite guideline directed medical therapy (gdmt), at minimum, patient on diuretic use; * lvef ≥35% * tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (superscript)) and ≤55 mm (or 29 mm/m2 (superscript)) exclusion criteria: * pregnant or lactating female; * severe uncontrolled hypertension (sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg); * previous tricuspid valve repair or replacement; * severe coronary artery disease; * mi or known unstable angina within the 30-days prior to the index procedure; * any pci within 30 days prior to the index procedure or planned 3 months post the index procedure; * chronic oral steroid use (≥6 months); * life expectancy of less than 12-months
deep learning model for predicting a peripheral venous waveform-based pulse pressure variation

Conditions: Peripheral Vein; Arterial Wave Reflections; Pulse Pressure Variation; Stroke Volume Variation; Deep Learning Model

Summary: pulse pressure variation is a monitoring index that indicates the response to fluid therapy in patients receiving mechanical ventilation, and is used as a reference for patients with unstable hemodynamic conditions. however, it is invasive because it requires arterial puncture to collect it. in a previous study by the investigators, the investigators developed and verified an artificial intelligence model that predicts stroke volume variation, in real time using only the central venous pressure waveform. however, since a large vein such as the jugular vein must be punctured to collect the central venous pressure waveform, it is still invasive, and its clinical utility is low. therefore, in this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. the investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .

in this study, the investigators collected waveforms from peripheral veins that are less invasive and can be a wide range of applications because all surgical patients have them. the investigators aimed to develop and verify an artificial intelligence model that predicts pulse pressure variation obtained from peripheral venous waveforms .

Eligibility criteria:
inclusion criteria: * patients who voluntarily agreed and signed the written informed consent form before participating in this study * adult aged 19 years or older * american society of anesthesiologists physical class (asa) 1-3 * patients scheduled for elective hepatectomy under general anesthesia * patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation * non-smokers with normal pulmonary function exclusion criteria: * patients with abnormal findings on electrocardiogram before surgery * patients who cannot undergo peripheral venous puncture
effect of acupressure on recovery of bowel function in patients post cesarean section

Conditions: Acupressure; Post-Op Complication; Cesarean Section; Bowel Ileus

Summary: research objectives to compare the efficacy of acupressure with no acupressure to examine time to first flatus in patient post cesarean section ; acupressure at st-36 zusanli (lateral to anterior crest of tibia, in the tibialis anterior muscle) research hypothesis patients who received acupressure will have earlier flatus passage

research design randomized controlled trial. compare between the investigators is who assess the acupressure with control group is the participants do not assess the acupressure

Eligibility criteria:
inclusion criteria: 1. pregnancy woman age 18-45 years 2. general anesthesia 3. co-operate in research 4. can speak in thai language exclusion criteria: 1. twin pregnancy 2. placenta previa 3. placental abruption 4. chorioamnionitis 5. complication intraoperation (bowel or bladder injury) 6. post partum hemorrhage 7. abdominal adhesion 8. opertative time more than 2 hour 9. history gastrointestinal surgery 10. prior acupressure 11. neurological disease 12. neuromuscular disease 13. hepatic disease
polish-italian-hungarian randomized thrombectomy trial

Conditions: Myocardial Infarction

Summary: aim primary percutaneous coronary intervention efficacy improvement by diver ce thrombectomy system leading to thrombus reduction. study design: multicenter, prospective, opened, randomized. primary endpoints: st resolution \>70% 60 minutes after pci secondary endpoints: thrombectomy system efficacy/passing trough lesion with thrombus reduction according do timi thrombus scale ≥ 1 timi 3 flow after pci mbg 3 cmr - infarct size, measurement of left ventricular end-diastolic edv and end-systolic volumes esv and ejection fraction (ef) echo: measurement of left ventricular end-diastolic edv and end-systolic volumes esv, ejection fraction (ef) and wall motion score index (wmsi) major cardiac events /cardiac death, remi, repci (tvr, tlr, non infarct involved vessel) or cabg/ 6 month follow up rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final timi \ 1


Eligibility criteria:
inclusion criteria: * st elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm st segment elevation in two lead * minimum 3 mm st segment elevation in one leads * vessel reference diameter \> 2.5 mm * when vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation exclusion criteria: * contraindications to pci (contrast allergy, no possibility to stent implantation) asa, thienopirydins or gp iib/iiia inhibitors * active bleeding or coagutopathy * prior cabg or pci * known ejection fraction ef \<35% * cardiogenic shock /sbp \< 90 mmhg, iabp and/or catheloamins usage/ * lbbb, pacemaker rhythm * severe calcifications * previous myocardial infarction * stroke history * patient directly after reanimation * known thrombocytopenia- platelets \< 100 000 * pregnancy * cancer disease * no future patient cooperation expected * patient's taking part in the other clinical trials * fibrynolisis directly administered before pci * renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis * contraindications to pci (contrast allergy, no possibility to stent implantation) asa, thienopirydins or gp iib/iiia inhibitors * active bleeding or coagutopathy * prior cabg or pci * known ejection fraction ef \<35% * cardiogenic shock /sbp \< 90 mmhg, iabp and/or catheloamins usage/ * lbbb, pacemaker rhythm * severe calcifications * previous myocardial infarction * stroke history * patient directly after reanimation * known thrombocytopenia- platelets \< 100 000 * pregnancy * cancer disease * no future patient cooperation expected * patient's taking part in the other clinical trials * fibrynolisis directly administered before pci * renal insufficiency (creatynine \> 220 µmol/ml), hemodialysis * liver insufficiency
closed loop spinal cord stimulation for complex regional pain syndrome

Conditions: Complex Regional Pain Syndromes

Summary: the primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.

after being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). they will undergo a trial period with a temporary spinal cord stimulator for 7 days. after the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. the patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. there will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.

Eligibility criteria:
inclusion criteria: * 18 years or older * neuromodulation naive patients with unilateral crps type 1 or type 2 (defined by budapest criteria) * pre-procedure psychological clearance exclusion criteria: * younger than 18 years * prior neuromodulation including spinal cord stimulation * prior dorsal root ganglion stimulation * prior peripheral nervous system stimulation * anatomical obstacles to dorsal column lead placement
distribution of risk factors in ocular hypertension and open-angle glaucoma patients in canada

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this descriptive, non-interventional study will collect information on the presence of risk factors in newly diagnosed ocular hypertension and open-angle glaucoma patients in canada.


Eligibility criteria:
inclusion criteria: * subjects diagnosed at study visit or within 3 months of visit with oh * oag (to include poag, ntg, pigmentary and pseudoexfoliation glaucoma) exclusion criteria: * no prior treatment for oh or oag * no prior ocular surgery or history of ocular trauma

Keywords: glaucoma, open-angle ocular hypertension risk factors canadian
the safety of the 6-minute walk test after acute myocardial infarction

Conditions: Acute Myocardial Infarction; Six-minute Walk Test

Summary: background: the six-minute walk test (6mwt) is widely used as an instrument for assessing the functional capacity of cardiac patients. it's a simple, low cost test that better reflects day-to-day activities when compared to other tests. its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. objective: to evaluate the safety of the 6mwt performed on the third day after acute myocardial infarction (ami). methods: it's a cross-sectional study, to be accomplished in hospital são paulo - federal university of sao paulo. individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. the 6mwt will be performed according to the norms of the american thoracic society. the distance covered during the 6mwt will be measured as weel as adverse events.


Eligibility criteria:
inclusion criteria: * ami patients exclusion criteria: * previous history of ami * recurrent or refractory pain * presence of neuromuscular diseases * acute or chronic lung diseases * inability to perform the functional test
internet-delivered psychodynamic therapy for depression

Conditions: Depression

Summary: the overall aim of this study is to develop and test a psychodynamic internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of major depressive disorder * 15 or more on madrs-s exclusion criteria: * severe depression (more than 35 on madrs-s or based on interview) * severe psychiatric condition (e.g. psychosis or bipolar disorder) * suicidal (measured in diagnostic interview) * changed medication during the last three months
comparative evaluation of safety and immune activity of new immunotherapeutic agents for hdm allergic rhinitis patients

Conditions: Mite Allergy; Rhinitis, Allergic; House Dust Mite Rhinitis

Summary: when administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.


Eligibility criteria:
inclusion criteria: * patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen. * immunocap® titer \> 3.49 kua/l for the house dust mite antigen. * determined to be suitable for clinical trials as a result of laboratory tests. exclusion criteria: * patients with uncontrolled, severe, or moderate asthma according to the global initiative for asthma (gina) guidelines. * in case of lactation or pregnancy. * if an infectious disease that may affect this study is identified. * patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug. * if the allergy skin prick test is negative for the house dust mite antigen.

Keywords: microneedle micro array patch house dust mite rhinitis
outpatient rehabilitation intervention for young children with sma

Conditions: Spinal Muscular Atrophy

Summary: an outpatient rehabilitation program for children (6 months to less than 6 years old) with spinal muscular atrophy (sma) treated with genetic based therapies is being studied. participants will participate in a 12-week therapy program where they receive 45 minutes each of occupational therapy and physical therapy each week. home exercises will also be prescribed to be completed 5 days per week. at the end of the therapy program, there will be a 12-week period of no therapy where only home exercises will be completed. assessments and program evaluation will occur at the beginning (week 0) and end of the rehabilitation program (week 24), then at the end of the no therapy block (week 24).

the standard of care for sma has historically been physical therapy (pt) and occupational therapy (ot) often focused on strategies that reduce the risk of secondary side effects such as joint tightness. recently, three genetic based therapies: nusinersen, onasemnogene abeparvovec and risdiplam, have been approved as treatment by health canada. genetic based therapies have provided improvements in physical function for children with sma. currently, there is no evidence-based guidance regarding rehabilitation to increase function for children with sma that have received genetic based therapies. additionally, there is a lack of published evidence regarding the type of rehabilitation programs and the impact that rehabilitation has on physical function. an outpatient rehabilitation program for children (6 months to less than 6 years old) with spinal muscular atrophy (sma) treated with genetic based therapies is being proposed and its feasibility being evaluated. participants will participate in a 12-week therapy program where they receive 45 minutes each of occupational therapy and physical therapy each week. home exercises will also be prescribed to be completed 5 days per week. at the end of the therapy program, there will be a 12-week period of no therapy where only home exercises will be completed. assessments and program evaluation will occur at the beginning (week 0) and end of the rehabilitation program (week 24), then at the end of the no therapy block (week 24).

Eligibility criteria:
inclusion criteria: * sma (type i, ii or iii) diagnosis; * receives genetic based therapy; * aged 6 months to less than 6 years old; * able to participate in weekly therapy at holland bloorview (i.e., can attend in-person sessions); * able to bring appropriate respiratory equipment to weekly therapy sessions, if required; * substitute decision makers (sdms) must be able to speak and read english; * child participant must be able to understand/follow directions in english, as age appropriate; * sdms must consent to participate on behalf of their child. exclusion criteria: * live outside of ontario; * tracheostomy or use of daytime ventilation (excluding ventilation used during naps).

Keywords: young children pediatric rehabilitation feasibility study pilot study