Kornimate/medical-research-clean huggingface dataset:
safety of fondaparinux as post partum thromboprophylaxis

Conditions: Thromboembolism in the Puerperium

Summary: venous thromboembolism (vte) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. perinatal thromboprophylaxis is often administered based on risk-factor assessment. low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. the investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis. the investigators planned a prospective, single arm, open label study. women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 rcog guidelines were recruited. each patient would receive subcutaneous injection of fondaparinux, 2.5mg daily for 10 days. the investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

all women were taught the injection technique and counselled regarding the symptoms of bleeding and vte, prior to discharge. all patients were also advised to wear compression stockings and ensure adequate hydration at home the primary outcome measure was occurrence of pulmonary embolism or deep vein thrombosis suggestive by clinical symptoms and assessment. secondary outcome measures were allergic reaction and bleeding tendency such as secondary post-partum haemorrhage, spinal site bleeding and wound haematoma. allergic reaction and bleeding tendency in neonates were also recorded.

Eligibility criteria:
inclusion criteria: * malaysian * age 18 and above * scores asintermediate risk on 2015 royal college of obstetricians \& gynaecologists (rcog) vte risk assessment exclusion criteria: 1. hypersensitivity to fondaparinux 2. patients with bleeding disorders - haemophilia , thrombocytopenia, von willebrand's disease. 3. weight \< 50 kg 4. patients with primary postpartum haemorrhage 5. patients who already on anti - coagulants 6. medical co morbidities - systemic lupus erythematosus, heart failure, nephrotic syndrome, type 1 diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user 7. uncontrolled hypertension ( blood pressure \> 200 mmhg systolic or \> 120 mmhg diastolic )

Keywords: pregnancy thromboembolism prophylaxis
efficacy and safety of aliskiren and valsartan versus placebo in patients stabilized following an acute coronary syndrome

Conditions: Post Acute Coronary Syndrome; Myocardial Ischemia

Summary: the purpose of this study is to test the hypothesis that the inhibition of the renin-angiotensin-aldosterone system (raas) with the angiotensin receptor blocker valsartan or the renin antagonist aliskiren will improve ventricular hemodynamics, as reflected by a greater reduction in levels of n-terminal prob-type natriuretic peptide (nt-probnp) compared to placebo in subjects stabilized following acute coronary syndrome (acs) who are determined to be at high risk due to an elevated concentration of natriuretic peptides.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years old or older * subjects who are hospitalized for ischemic chest discomfort at rest lasting at least 10 minutes and consistent with cardiac ischemia * final diagnosis of acute coronary syndrome * elevated concentrations of natriuretic peptide 3-10 days after admission for their qualifying acute coronary syndrome event exclusion criteria: * known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (arbs), renin antagonists, or to drugs with similar chemical structures. * presence of clinically overt heart failure * known evidence of left ventricular systolic dysfunction * percutaneous coronary intervention (pci) less than 24 hours before randomization. * patients on chronic acei or arb therapy for whom therapy with an acei or arb is clinically required with no reasonable alternative therapy available. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: post acute coronary syndrome acute coronary syndrome b-type natriuretic peptide n-terminal pro-b-type natriuretic peptide myocardial infarctions
comparison between natural sleep endoscopy and drug-induced sleep endoscopy in patients with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive; Sleep Apnea; Sleep Apnea Syndromes; Apnea; Respiration Disorder; Respiratory Tract Disease; Dyssomnia; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Nervous System Diseases; Hypnotics and Sedatives; Central Nervous System Depressants; Propofol; Midazolam; Physiological Effects of Drugs; General Anesthetics

Summary: drug-induced sleep endoscopy (dise) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (osa). this is due to the fact that it allows many patients to be examined in a daytime setting. this procedure uses sedative drugs to mimic natural sleep. however, associations with the site of upper airway (ua) collapse during natural sleep remain unclear. the aim of this explorative study is to identify ua collapse in patients with osa using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (nse).

patients with moderate to severe osa requiring dise will be recruited for this prospective study at the outpatient clinic. patients will undergo a nse at the sleep lab at night, and a dise at the operating theatre within three months. both the nse and dise set-up will include gold-standard flow measurements, acoustic analysis and esophageal pressure measurements.

Eligibility criteria:
inclusion criteria: * diagnosis of osa with a baseline ahi ≥ 15 per hour based on full polysomnography * body mass index (bmi) ≤ 35 kg/m² * capability of giving informed consent and willingness to undergo nse exclusion criteria: * central sleep apnea (defined as cahi ≥ 30% of total ahi) * inability to sleep in a supine position due to a medical condition * inability of the patient to understand and/or comply to the study procedures * neuromuscular disorders or craniofacial anomalies affecting the ua * sedative medication use (opioids and muscle relaxants) * active psychiatric disorders (psychotic illness, major depression, anxiety attacks, excessive alcohol or drug use) * severe or decompensated cardiac or respiratory diseases * medical history of known causes of tiredness by day or severe sleep disruption (insomnia, plms, narcolepsy) * contra-indications for dise: i.e. fitness for general anesthesia (asa\>3), allergy to sedative agent(s) and an expected extremely difficult airway * pregnancy or willing to become pregnant

Keywords: sleep endoscopy sedation airflow analysis
can airflow limitation in chronic obstructive pulmonary disease (copd) be reversible by drugs?

Conditions: Chronic Obstructive Pulmonary Disease

Summary: critical combination of various approved drugs in management for patients suffering with copd.


Eligibility criteria:
inclusion criteria: * current or past smoker copd exclusion criteria: * history of significant occupational or other environmental exposures or a connective tissue disease

Keywords: copd macrolid reversibility theophylline corticosteroids symptoms pft
shared decision making in surveillance for distant metastasis in breast cancer

Conditions: Breast Cancer; Survivorship; Quality of Life

Summary: in this study, clinical impacts of shared decision making between physicians and patients in strategy of surveillance for asymptomatic patients who ended the primary treatments on quality of life would be investigated

\[background\] 1. shared decision making between patients and physicians when breast cancer patients encounter decision making in the initial treatment process has already been included in the recommendations for breast cancer treatment in each country. however, in the follow-up stage using various imaging tests after the initial breast cancer treatment, the evidence of decision making is very poor and the patient who understands this well and actively participates in the process of deciding the follow-up strategy are almost none. 2. major guidelines including nccn, asco and esmo recommend surveillance with routine imaging such as sonography and mammography, and does not recommend advanced imaging tests for asymptomatic patients. these guidelines are based on two prospective randomized trials conducted in 1994. despite many international medical recommendations, many institutions around the world are increasingly using distant metastasis tests in belief of improving the survival rate through early detection of distant metastasis and of improving the emotional stability of doctors and patients. 3. in this study, clinical impacts of shared decision making in strategy of surveillance for asymptomatic patients on quality of life would be investigated by prospective randomized pragmatic trial. additionally, oncological results would be analyzed and real world data of patients preference would be gathered \[study design\] prospective, single-institutional, randomized pragmatic trial \[statistical considerations\] with 5% significance level and 90% power, 132 patients are needed in each group. assuming a 28% drop out rate, 368 patients need to be recruited. \[randomizations\] web-based randomization would be conducted stratified to subtypes. \[objectives\] 1. primary objective - qol (when enrollment, after 1 and 2 year - fact-b score) 2. secondary objectives * depression - anxiety scale (hads score) * recurrence-free survival * patients' preference for surveillance in sdm group * cross over rate in sdm group

Eligibility criteria:
inclusion criteria: * women between 20-70 years * invasive unilateral breast carcinoma with histological confirmation * history of invasive breast cancer * tmn stage i-ii according to ajcc 7th * histologically or radiologically no suspicion of distant metastases * performance status corresponding to ecog grade 0-2 * no psychological and geographical restriction in follow-up * written informed consent exclusion criteria: * history of any cancer in the previous 5 years * bilateral breast cancer * male breast cancer * patients who are planning for surveillance in other institutions * unable to understand and fill out questionnaires
pulmonary rehabilitation in patients before lung transplantation (ltx)

Conditions: COPD; Pre-Lung-Transplantation; Hypercapnia; Respiratory Insufficiency

Summary: the purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6mwd) and physical activity, measured via dynaport and actibelt aktivitätsmonitor, dyspnoea (vas), quality of life (hrql (sf36, euroqul)), anxiety and depression (hads)and paco2-behavior under physical activity.


Eligibility criteria:
inclusion criteria: * pre-ltx (listed for lung-transplantation or currently undergoing evaluation) * copd stadium iv gold * α-1-antitrypsin-deficiency-emphysema * respiratory insufficiency * oxygen therapy (ltot) exclusion criteria: * serious exacerbation (symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation * clinical signs of manifest heart insufficiency * acute coronar syndrome * left heart insufficiency(ef \< 40%) * missing compliance

Keywords: copd pre-lung-transplantation intervall versus continuous training 6 mwd
qualitative assessment of the brief contact intervention "stay in contact" in suicide prevention

Conditions: Suicide and Self-harm

Summary: background: for 40 years, brief contact interventions (bcis) have been presented as promising approaches in suicide prevention but patient's experiences of bcis are less investigated. aim: understand mechanisms of bcis after suicide attempt, through patient's experience of a french bci "stay in contact" and assess its impact on seeking care during suicidal crisis. method:this is a single-center, non-interventional, prospective qualitative study using phone call interview on a bci, 6 months after suicide attempt behavior. statistical analysis data were analyzed using statistical software (version 9.4, sas institute inc., cary, north carolina, usa). chi-squared test was used to assess qualitative variables and t-test to evaluate quantitative variables, with p\<.05 considered significant.

the baseline interviews were conducted on the phone, on weekdays, during a mean time of 10 to 15minutes by a trained resident in psychiatry as the only interviewer. the interviewer didn't participate in patient's medical care nor in the follow-up interventions. the interviewer didn't look in patients file before conducted over the phone interviews and had only administrative information on the study subjects: first and last name, age, sex, phone number. the phone call interview wasn't considered as an intervention. whenever the interviewer judged necessary that a patient needed more intensive treatment, the relevant referral to help was done.

Eligibility criteria:
inclusion criteria: * be male or female, be aged 18 or older, have a situation permitting follow-up contacts by phone. exclusion criteria: * be placed under supervision by the law such as guardianship and curatorship, be incarcerated and refusing to participate to the bci
efficacy of group life skill intervention to enhance well-being among higher education students

Conditions: Psychological Distress; Mental Health Issue; Quality of Life; Well-Being, Psychological

Summary: the primary aim of this study is to investigate the efficacy of group life skills intervention designed to improve the well-being, life skills, and quality of life of higher education students. the study also identifies the feasibility of the life skill intervention in the context of pakistan. we will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.

the primary aim of this study is to investigate the efficacy of group life skills intervention designed to improve the well-being, life skills, and quality of life of higher education students. the study also identifies the feasibility of the life skill intervention in the context of pakistan. we will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment. study tasks: participants, who are university students aged 21-30 years, were asked to provide informed consent to participate in the study. they completed questionnaires to assess their life skills, psychological distress, well-being, and quality of life as a pre-assessment. participants in the intervention group undergo the life skill intervention, which includes activities like team building skills, leadership skills, self-respect and appreciation, effective communication skills, dealing with stress, positive thinking, enhancing confidence, volunteering, decision taking, problem solving, conflict resolution, negotiating. after the intervention, participants completed a post-assessment questionnaires to measure changes in life skills, psychological distress, well-being, and quality of life. there will be a control group that does not receive any treatment. comparison group: researchers compared the outcomes between the intervention group, who received the life skill intervention and the control group, who did not receive any treatment. this will help us determine if the intervention had a significant impact on life skills, psychological distress, well-being, and quality of life outcomes for university students.

Eligibility criteria:
inclusion criteria: * students of public sector university of pakistan. * students aged 21-30. * students accessed with decreased psychological well-being. exclusion criteria: * students of private universities in pakistan * students with any physical disability. * students having a prior history of psychiatric illness.

Keywords: efficacy group life skill intervention psychological distress life skills quality of life well being
an evaluation of a public health campaign related to persistent pain in the united kingdom

Conditions: Chronic Pain; Pain, Chronic; Pain, Back; Musculoskeletal Pain; Arthritis; Back Pain

Summary: the goals of this study are * to define what the public perceptions of persistent pain using a national survey * explore relationships between the reported pubic beliefs and demographic factors collected. * to evaluate the impact of a public health campaign to increase awareness of persistent pain and develop understanding of pain that aligns with contemporary science.

this study included a cross sectional survey of the uk population to understand what the beliefs are regarding persistent pain. this survey will be distributed electronically using social media and to a scottish council. differences in beliefs will be explored using the demographic data collected. the second aspect of the study is the evaluation of a public health campaign called 'flippin pain'. this study component included the evaluation of online webinars with pre, post, 3 month, 6 month and 12 month longitudinal data collection. one of the online seminars also included the qualitative evaluation using semi structured interviews. the third part of the study was the evaluation of a community outreach tour in the county of lincolnshire, united kingdom. this included the collection of pain belief data before an in person seminar, immediately afterwards, then at 3 months. semi structured interviews were also conducted with participants who attended the webinars. as part of the outreach tour an interactive pop up tent gave members of the public an understanding of pain using practical demonstrations. the was evaluated using short semi structured interviews along with written summaries offered by the participants before and immediately after experiencing the practical demonstrations. after the community outreach tour, two focus groups were conducted with the campaign volunteers with an aim to understand the experience of those involved. the focus groups asked the participants to reflect on the successes and challenges of delivering a community based public health outreach tour.

Eligibility criteria:
inclusion criteria: * uk cross sectional survey - all adults over the age of 18 who are the capable of offering informed consent) * online webinar study - adults over the age of 18 who attend an online webinar related to persistent pain * community outreach tour seminar - adults over the age of 18 who attend an in person seminar * brain bus - adults over the age of 18 who experience the interactive demonstrations relating to persistent pain * focus groups - volunteers who participated in the flippin pain community outreach tour within the county of lincolnshire exclusion criteria: * individuals younger than 18 years of age. * for the cross sectional uk survey, adults who lived outside of the uk were excluded.

Keywords: persistent pain public health
omacor plus standard therapies in post myocardial infarction (mi) subjects evaluation: the optimise observational study

Conditions: Myocardial Infarction (MI)

Summary: the optimise study is a prospective, multi-center, multi-national, structured data collection initiative, first compiling data on the current treatment of post myocardial infarction patients (screening-log) and then, prospectively evaluating only those patients being prescribed omacor as part of their standard secondary prevention treatment. the aim is to observe the omacor cohort of patients for a period of 12 months, collecting long term observational data as clinical and patient-reported outcomes, especially, but not exclusively, recurrent non fatal myocardial infarction (mi), sudden death, or new congestive heart failure (chf). no predefined additional visits, medical tests, labs, procedures or interventions will be mandated. only results from routinely performed tests, labs, procedures and/or interventions will be collected if available.


Eligibility criteria:
inclusion criteria * male and female patients, from the screening-log, having been prescribed prior to their inclusion in the study omega-3-fatty-acid ethyl esters (omacor) as adjuvant treatment in secondary prevention after their myocardial infarction, in addition to standard therapy \[e.g. statins, antiplatelet medicinal products, beta blockers, angiotensine converting enzyme (ace) inhibitors/angiotensine ii receptor blockers (arbs), etc\]. exclusion criteria * omega-3-fatty-acid ethyl esters (omacor) approved contra-indication as per the labeling information in participating countries

Keywords: secondary prevention post mi
non-incised papillae surgical approach (nipsa) and connective tissue graft plus emdogain for periodontal defects

Conditions: Periodontitis; Periodontal Bone Loss; Periodontal; Lesion

Summary: the present study pretends to show the results of combining a modification of the non-incised papillae surgical approach (nipsa) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.


Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis. * plaque index and bleeding index of \< 30%. * periodontal lesions with pocket probing depth \> 5 mm. * intrabony defect \> 3 mm. * intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall. exclusion criteria: * patients with systemic diseases that contraindicated treatment. * third molars. * teeth with incorrect endodontic or restorative treatment.