Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of gefapixant (mk-7264) in women with chronic cough and stress urinary incontinence (mk-7264-042)

Conditions: Chronic Cough

Summary: the purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (sui) in adult female participants with refractory or unexplained chronic cough. the primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced sui episodes over 12 weeks.


Eligibility criteria:
inclusion criteria: * has a chest radiograph or computed tomography scan of the thorax (within 5 years of screening and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other lung disease * has chronic cough (defined as duration of \>8 weeks after onset of cough symptoms) for ≥12 months * has a diagnosis of refractory chronic cough or unexplained chronic cough * has symptoms of sui, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥3 months * is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance exclusion criteria: * is a current smoker * has given up smoking within 12 months of screening * is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years) * has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening * has a history of chronic bronchitis * has a history of surgery to treat sui within 1 year of screening * has a history of other specialized treatments for sui, including intravesical balloon or urethral bulking agent therapy * has other external incontinence device currently or within 1 month of screening * has a history of grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening * has a neurogenic bladder * has a history of adult nocturnal incontinence * has a history of continuous urine leakage within 1 month of screening * has a history of interstitial cystitis * has a history of neurological disease or injury * has active or recurrent urinary tract infection * has a history of having a permanent urinary catheter or any urinary catheterization within 3 months of screening * has a history of malignancy ≤5 years prior to signing informed consent * is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse * has a known allergy to gefapixant or its excipients * has donated or lost ≥1 unit (\~300 ml) of blood within 8 weeks prior to first dose of gefapixant * requires certain medications and/or other therapies that may impact their cough or bladder function * has previously received gefapixant * is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study

Keywords: cough urinary incontinence, stress respiration disorders respiratory tract diseases signs and symptoms, respiratory signs and symptoms
validation of sodergren score for haemorrhoids in malaysia

Conditions: Hemorrhoids

Summary: to validate the ability of the sodergren score in guiding the management of symptomatic haemorrhoids in a malaysian population.

all participating, consented subjects will be scored with the sodergren score prior to receiving a standardized ambulatory treatment regime. the questionnaire will be self-administered by the subjects. subjects whom are not able to self-administer the questionnaire will be assisted by the investigator or research assistant. the nature and severity of the subject's haemorrhoidal symptoms are considered as the pre-treatment baseline. a follow up period of 12 months will be carried out post treatment for failure or success of treatment. the data collected will be compared to pre-treatment scores and analyzed statistically.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * male and female genders * previous ambulatory treatment * internal haemorrhoids exclusion criteria: * presence of external haemorrhoids * prior haemorrhoidal surgery * anti-coagulant therapy * anal fissure * inflammatory bowel disease * underlying colon-rectal malignancy

Keywords: hemorrhoids sodergren score validation
reversal of atrial substrate to prevent atrial fibrillation pilot study

Conditions: Atrial Fibrillation

Summary: this is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (af).

atrial fibrillation (af) is a major health problem, with a prevalence of 0.4-1% of the population. it is associated with a six-fold risk of stroke and a two-fold increase in mortality, the main cardiac reason for death one year after presenting to the emergency department with af is heart failure. it results in high healthcare costs, recurrent ed visits and hospitalizations. the burden of disability associated with af has been found to increase by 20% from 1990-2010. af was also cited as one of the seven causes of death that has been increasing worldwide. prevention of af has not been a focus of past treatments and it is well known that elevated body mass index, hypertension, smoking, increased alcohol intake, lack of exercise and sleep apnea are risk factors for af. there is a lack of randomized, multicenter data proving that a strategy of aggressive risk factor modification will prevent and modify af. upstream therapy for af has been of considerable interest, and benefit has been demonstrated in primary prevention of af. catheter ablation has demonstrated success over current medical therapies for long-term rhythm control, but recurrence remains high, irrespective of ablation strategy. this study is a feasibility study to determine whether a complex and multi-component risk factor modification can be successfully implemented.

Eligibility criteria:
inclusion criteria: * patients with symptomatic (ccs-saf ≥2) recurrent paroxysmal or persistent nonvalvular atrial fibrillation despite rate control, desiring catheter ablation and * one of : bmi\>27, bp\>140/90 or history of hypertension, alcohol use \> recommended limit, current smoking, diabetes with hga1c\>7%, physical inactivity (\<150 minutes/week). (definitions: recurrent paroxysmal - at least 4 episodes of symptomatic af in the prior 6 months, with or without cardioversion; persistent af lasting greater than 7 days but less than 3 years; af must be documented on a holter, rhythm strip or electrocardiogram within the last 24 months.) exclusion criteria: * permanent af (af lasting \> 3 years) * prior catheter ablation for af * left ventricular ejection fraction \<30% * left atrial size \> 5.5 cm * nyha iv heart failure * participation in a cardiac rehabilitation program within the last year * currently performing exercise training 150 minutes/week of moderate to vigorous physical activity * unable to exercise * unable to give informed consent * other noncardiovascular medical condition making 1 year survival unlikely

Keywords: risk factor modification catheter ablation
robotic vs. conventional minimal-invasive inguinal hernia repair

Conditions: Hernia, Inguinal; Robotic Surgical Procedures

Summary: minimal invasive techniques have become a well established approach for inguinal hernia repair over the last decade in developed countries. different techniques such as total extraperitoneal endoscopic hernioplasty (tep) and transabdominal preperitoneal hernia repair (tapp) have been described. these studies show comparable results in short and long term outcome. robotic inguinal hernia surgery enables an even more precise dissection within the preperitoneal layer thus preserving the nerves of the lateral abdominal wall. this may translate into a reduced level of acute and chronic postoperative pain as previously reported by retrospective case series. the role of robotic surgery for inguinal hernia repair in regard of postoperative pain and recovery has not been investigated in randomized and blinded clinical studies yet. with this randomized and blinded trial the investigators compare robotic tapp (rtapp) to conventional tep with a decreased pain level shortly after surgery as primary outcome (numeric rating scale - nrs). a reduced postoperative nrs for pain may translate into faster recovery and less chronic pain, secondary endpoints include comparison of pain in a longer course (short-form inguinal pain questionnaire (sf-ipq)), quality of life / health status (baseline short form-12 (sf-12), carolinas comfort scale (ccs)), complications (comprehensive complication index - cci), rate of recurrence, , economic impact in terms of costs of surgery per patient, for the institution, the sick leave and the cost-effectiveness of health intervention (sf-6d, eq-5d, icecap-o). also included are ergonomics for the surgeon (nasa tlx).


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age and able to understand and give their informed consent for the study. * primary unilateral or bilateral hernia exclusion criteria: * recurrent hernia * with previous open abdominal surgery at or below the umbilicus * need of an open inguinal hernia repair (patient's preference, unable to undergo general anesthesia, unable to tolerate pneumoperitoneum) * liver disease defined by the presence of ascites * end-stage renal disease requiring dialysis * unable to give informed consent * need of an emergency surgery * pregnancy
research of molecular and metabolic markers in oligodendrogliomas comparatively to other brain tumours

Conditions: Oligodendrogliomas

Summary: at present, diagnosis of oligodendroglioma is made on histological and radiographic criteria in the french mayo-ste anne classification. the less frequent grade a oligodendrogliomas are characterized by no vascular contrast on rmn evaluation comparatively to grade b forms. this benign histological subtype relapses in few cases with a more aggressive histology. to determine these relapsed cases at diagnosis, a collection of tumour begun in february 2004. then, our study was designed to identify diagnostic molecular and metabolic markers that could eventually be used as a signature characterising grade a versus grade b oligodendrogliomas. the molecular analysis will use genomic techniques like allelotyping study, quantitative real-time pcr, gene sequencing , serial analysis of genomic expression and immunohistochemistry, since the metabolic study will be the spectroscopic examination of in vivo tumour. this study will include paediatric and adult patients followed for oligodendrogliomas, medulloblastomas and gliomas to compare the different tumour signatures. all these results will be correlated to survival and clinical features.


Eligibility criteria:
inclusion criteria: * paediatric and adult patients (\> 1 year of age) * patient with oligodendroglioma or medulloblastoma or glioma * possibility of 3 year follow-up * patient consent obtained exclusion criteria: -

Keywords: brain tumours oligodendrogliomas allelotyping sage presence of molecular abnormalities statistically linked to survival or response to chemotherapy
experiences of visitors to a regional major trauma intensive care unit

Conditions: Major Trauma

Summary: since 2011, people who have had a serious accident in england are no longer looked after at the hospital nearest to them. instead, they are cared for at a specialist hospital called the regional major trauma centre. this is so that they can get the best possible care from specialist professionals. st george's is the regional major trauma centre for the 2.6 million people living in south west london and surrey county. this area stretches about 40 miles across. about one fifth of major trauma patients who come to st george's live more than one hour's journey away. their visitors often travel a similar distance or even further. family members and friends play an important part during the patient's stay. it is important to support visitors. the aim of this study is to describe the experiences of visitors whose family member or friend has been admitted to the major trauma intensive care unit at st george's. in particular, the aim is to describe the experiences of visitors who travel from far. first, ten visitors will be interviewed to find out more about their experiences. from these data, a survey questionnaire will then be developed and approximately 150 visitors who have been to st george's in recent months will be surveyed. this will give in-depth insights to understanding peoples' experiences of visiting at st george's, and what people thought was going well and things that could be better. the study will end with a service improvement workshop with representatives from the team at st george's and visitors. study findings will be discussed and decisions on what should be improved will be made. this study is being funded by st george's hospital charity. the study runs from august 2017 to october 2018.


Eligibility criteria:
inclusion criteria: * visitors (i.e. designated next of kin and/or other family member or friend with a close relationship and significant involvement in the patient's circumstances and care) of a patient who has been admitted to intensive care at st george's university hospitals nhs foundation trust under the major trauma care pathway * ordinary residence further away than one hour's drive from st george's hospital (estimated driving time in mid-week mid-morning traffic according to google maps, equating to a distance of approximately 30 miles) * adults (18 years and over) * written informed consent (for semi-structured qualitative interviews) exclusion criteria: * ordinary residence within one hour's drive from st george's hospital (estimated driving time in mid-week mid-morning traffic according to google maps, equating to a distance of within approximately 30 miles) * limited english (for semi-structured qualitative interviews)

Keywords: intensive care patient- and family-centred care patient and public involvement south west london major trauma network service improvement survey questionnaire visitor experiences
iv acetaminophen and patent ductus arteriosus

Conditions: Patent Ductus Arteriosus

Summary: this is a randomized controlled trial to evaluate the efficacy of iv acetaminophen versus iv ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.


Eligibility criteria:
inclusion criteria: * preterm infants 23-30 weeks gestation, * pda requiring treatment exclusion criteria: * infection, * congenital heart disease, * genetic syndrome, * nec, * pulmonary hypertension, * hydrops, * intestinal perforation, * grade 3 or 4 ivh, * serum creatinine \>1.5, * previous treatment with a cox inhibitor.

Keywords: neonate acetaminophen
predictive a1c based on cgm data using cgm data

Conditions: Diabetes Mellitus, Type 1

Summary: introduction. the hemoglobin a1c (hba1c) reflects the average blood glucose level for last two to three months. recent advancements in the sensor technology facilitate the daily monitoring of the blood glucose using cgm devices. the future prediction of the hba1c based on the cgm data holds a critical significance in maintaining long term health of diabetes patients. a higher than normal value of the hba1c greatly increases the likelihood of diabetes related cardiovascular disease. goal. the aim this study is to predict the hba1c in advance by utilizing the cgm data through applying machine learning techniques. the outcomes of this research will assist in improving the health of diabetic patients. methods. this is a retrospective analysis. the investigators will de-identify and analyze 120 patients with t1d who using cgm sensor for last three months. past 15 days of cgm data will be analyzed and different glucose variability features such as time in range (tir), coefficient of variation (cv), mean amplitude of glycemic excursion (mage), mean of daily differences (modd), continuous overall net glycemic action (conga) will be extracted. a machine learning model will calculate (predict) hba1c in 2-3 months advance based on these 15 days of cgm data. to evaluate the performance of the proposed prediction model, predicted hba1c will be compared with the real hba1c.

this is a retrospective analysis. the investigators will de-identify and analyze 120 patients with t1d using continuous glucose monitoring (cgm) system for last three months. past 15 days of cgm data will be analyzed and different glucose variability features such as time in range (tir), coefficient of variation (cv), mean amplitude of glycemic excursion (mage), mean of daily differences (modd), continuous overall net glycemic action (conga) will be extracted. a machine learning model will be developed to predict hba1c in 2-3 months advance based on these 15 days of cgm data. the model is using linear regression, penalized regression (ridge regression, lasso regression and elastic net regression) in combination gradient boosting to calculate predictive a1c

Eligibility criteria:
inclusion criteria: * type 1 diabetes * flash glucose monitoring system exclusion criteria: * less than 70% od cgm data in the last 90 days.
evaluation of efficacy and safety of iloperidone in the acute treatment of manic or mixed episodes associated with bipolar i disorder

Conditions: Bipolar I Disorder

Summary: the aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with bipolar i disorder.


Eligibility criteria:
inclusion criteria: * male or female patients 18 to 65 years of age (inclusive) * diagnosed with bipolar i disorder, manic or mixed-type, per dsm-5 criteria * voluntary hospitalization for current manic episode exclusion criteria: * patients with a dsm-5 diagnosis of a psychiatric disorder other than bipolar i disorder that was the primary focus of treatment within the previous six months * patients who are experiencing a first manic episode or meeting criteria for rapid cycling
incidences of cuff-related trauma after noninvasive blood pressure measurement between with and without padding

Conditions: Complication

Summary: padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.

objective primary outcome : incidences of skin crease or petichiae after noninvasive blood pressure measurement ievery 5 minutes for 1 hour secondary outcome : factor related truma after noninvasive blood pressure measurement.

Eligibility criteria:
inclusion criteria: * health volunteer age \> 18 or patients exclusion criteria: * peripheral vascular disease * difference of blood pressure both arms \> 15 mmhg * acute dermal cappillary rupture * phlebitis * skin necrosis * acute radial nerve injury * deep vein thrombosis * rumpel-leede phenomenon * compartment syndrome
radiomic signature as predictive marker of response to chemoradiation and durvalumab in stage iii nsclc.

Conditions: Lung Cancer; Lung Cancer Stage III

Summary: the introduction of maintenance immunotherapy with the anti pd-l1 inhibitor durvalumab opened a new therapeutic window for stage iii nsclc patients who achieve at least stable disease after chemo-radiation, as shown by the randomized phase 3 pacific study. however, still half of the patients do progress at 12 months (up to 70% at 18 months). in this study, the investigators aim to test a non-invasive image-based approach, namely a "radiomics" platform, as a tool to define a higher or lower likelihood of response to chemo-radiation and durvalumab. for this purpose, we will retrospectively and prospectively collect and analyze a cohort of at least 70 stage iii nsclc patients treated with ct-rt followed by maintenance durvalumab.

specific aim (one): to collect and analyze ct scans at diagnosis and after chemoradiation, and assign them to a specific radiomic signature (blind assessment). specific aim (two): - to correlate the radiomics signatures to clinical outcome: the main measure will be progression-free survival at 6 months, the second will be overall survival at 24 months. this is an observational longitudinal retrospective/prospective study. criteria for study entry: * histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc) * age 18-80 * stage iiia-c disease judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists. * signed informed consent exclusion criteria: * inability to sign the informed consent * absence of analyzed ct images treatment: as per indication, patients should have received a thoracic radiation dose of at least 54 gy to the primary tumor and lymph nodes; all techniques are allowed. conventional fractionation or mild hypofractionation is also allowed. all different platinum-based chemotherapy regimens are admitted for the present study in combination with radiotherapy, given either concomitantly or sequentially, according to international guidelines for combination therapy in locally advanced nsclc. radiomic data extraction: after a pilot harmonization study phase, all ct scans will be analyzed using two different pre-defined signatures. the first one was developed by the institut gustave roussy, paris, and the second one by radiomics (liegi, belgium). these two signatures have been either linked to response to anti pd1 or to chemoradiation alone.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of non-small cell lung cancer (nsclc) * age 18-80 * stage iiia-iiib-iiic disease judged to be unresectable by a multidisciplinary team including pulmonologists, thoracic surgeons, medical and radiation oncologists. * signed informed consent exclusion criteria: * inability to sign the informed consent * absence of analyzed ct images

Keywords: durvalumab radiomics radiotherapy immunotherapy