Kornimate/medical-research-clean huggingface dataset:
open-label extension (ole) study to assess safety, efficacy, and tolerability of lorundrostat in subjects with hypertension

Conditions: Hypertension

Summary: this study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension

the purpose of the study is to evaluate the long-term safety, efficacy, and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension. this study consists of an open label treatment period of 52 weeks followed by a 2-week safety follow-up period. eligible subjects for mls-101-901 are those who were enrolled in one of the eligible parent studies, meet the eligibility criteria for this protocol, and agree, by signing an informed consent form (icf), to transition to this open label extension (ole) study at either the end-of-study (eos) visit or the end-of-treatment (eot) visit as required in the parent study protocol. a randomized treatment withdrawal (rtw) substudy will be performed in a subset of subjects meeting eligibility criteria. subjects who complete the open label treatment period will be invited to consent to an optional continuation period where they may remain on study until marketing authorization or early termination of the trial by the sponsor.

Eligibility criteria:
inclusion criteria: 1. written informed consent signed by the participant, obtained before any study-related assessment is performed 2. at least 18 years of age at the time of signing the informed consent form (icf) 3. completed the eot or eos visit (as applicable) in a lorundrostat study with the option of transitioning to the ole study, in accordance with the parent study protocol 4. fertile male subjects and female subjects of childbearing potential, and their partners, must agree to use an acceptable method of contraception from study entry to 28 days after the last dose of study drug 5. willing and able to comply with the study instructions and attend all scheduled study visits \[randomized treatment withdrawal substudy only\] 6. written informed consent to participate in the rtw substudy signed by the participant, obtained before any rtw study-related assessment is performed exclusion criteria: 1. women who are pregnant, plan to become pregnant, or are breast-feeding 2. use, or anticipated use during the course of the study, of a prohibited medication as listed in section 6.7.1 of the protocol 3. in the opinion of the investigator, any condition that will preclude participation in the study \[randomized treatment withdrawal substudy only\] 4. non-compliance with study medication(s) (defined as taking \ 125% of the study drug provided) during the first 12 weeks of mls-101-901

Keywords: blood pressure uncontrolled hypertension hypertension hypertensive
two strategies of rds treatment in newborns with birth weight > 1500 grams

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this study is to compare two different treatment strategies for rds in preterm infants \> 1500 grams and evaluate whether a selective surfactant administration would reduce the need of intubation, mechanical ventilation and surfactant use.

respiratory distress syndrome (rds) is a frequent respiratory problem of preterm infants and an important cause of morbidity and mortality. the management of this disease usually includes intubation, surfactant administration and mechanical ventilation in infants less than 1500 grams. however, in patients over this weight, the treatment has not been standardized and depends on the clinical progression of oxygen requirements. hypothesis: - early cpap and selective surfactant administration is an effective treatment for rds in infants \>1500 g. this could decrease or avoid intubation and surfactant administration. comparison(s): early surfactant administration, when the fio2 ≥ 0.4. compared to selective surfactant administration when the arterial to alveolar oxygen tension ratio (a/apo2) is ≤ 0.21.

Eligibility criteria:
inclusion criteria: * birth weight \> 1500 g. * first day of life. * clinical and radiological signs of rds. * oxygen requirement over 30% to reach an oxygen saturation of 88%. * parent's consent approved. exclusion criteria: * neonatal asphyxia, 5 minute apgar \< 3 or cord ph \<7.0. * cardiac or respiratory malformation. * chromosomal disease. * significative pneumothorax.

Keywords: respiratory distress syndrome surfactant nasal cpap
yoga in treating sleep disturbance in cancer survivors

Conditions: Fatigue; Cancer; Sleep Disorders

Summary: rationale: yoga may help improve sleep, fatigue, and quality of life in cancer survivors. purpose: this phase ii trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

objectives: primary * determine the efficacy of hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance. outline: this is a randomized, multicenter study. patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs \> 5). patients are randomized to 1 of 2 arms. * arm i: patients receive standard care for 6 weeks. patients may switch to the yoga intervention immediately after study completion. * arm ii:patients receive standard care for 2 weeks, followed by two 75-minute sessions of hatha yoga per week for 4 weeks. projected accrual: a total of 400 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * diagnosis of any type of cancer * more than 1 primary cancer allowed * has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months * patients can be on hormones such as tamoxifen, or monoclonal antibodies like herceptin * persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance) * able to read english * 21 years of age or older exclusion criteria: * no prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months * no diagnosis of sleep apnea * no concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab \[herceptin®\]) * no metastatic cancer

Keywords: cancer-related sleep disturbance fatigue sleep disorders
low cylinder toric

Conditions: Cataracts

Summary: study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (iol).


Eligibility criteria:
inclusion criteria: * diagnosed with cataracts * predicted residual corneal astigmatism between 0.75 and 1.03 diopters (d) exclusion criteria: * preoperative ocular pathology * planned monovision

Keywords: toric iol
can mass media campaigns reduce child mortality

Conditions: Diarrhoea; Malaria; Pneumonia; Breastfeeding; Under-nutrition

Summary: a cluster-randomised trial will be undertaken in burkina faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality. it is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.

the evaluation is conducted in 14 geographical locations throughout burkina faso. seven of these 14 clusters have been randomly allocated to receive the mass media intervention while the remaining 7 clusters will serve as controls. data collection includes household surveys in all 14 clusters at three "key" times: * at baseline: before the implementation of the intervention, between december 2011 and february 2012 to measure the current level of child mortality and evaluate current knowledge and behaviours of relevance to child health. * at midline: fifteen months after implementation of the intervention to evaluate the coverage of the intervention (in the intervention clusters) and, in each cluster, knowledge and behaviours. * at endline: two and a half years after implementation of the intervention to evaluate intervention coverage (in the intervention clusters), knowledge and behaviours and child mortality.

Eligibility criteria:
inclusion criteria: * residence in study clusters exclusion criteria: * none

Keywords: cluster-randomised trial comprehensive mass media campaign rural community radio under-five child mortality preventive and curative behaviours burkina faso health care seeking behavior childbirth
cooling to optimize organ life in donor study

Conditions: Organ Transplantation From Brain-dead Donors

Summary: the purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.


Eligibility criteria:
inclusion criteria: * age greater than 18 years;pronounced dead as per hospital brain-death criteria * accepted by organ procurement organization for organ donation * subjects within 3 hours of brain death pronouncement exclusion criteria: * consent cannot be obtained from authorized representative;mean arterial pressure \< 60 mmhg and/ or more than 2 vasopressor and/or inotrope use * presence of 2nd or 3rd degree heart block * ongoing extracranial hemorrhage * international normalized ratio \> 3.0 * donors with human-immunodeficiency virus infection * pregnancy

Keywords: brain-death organ donation
refractive and topographic changes after strabismus surgery

Conditions: Strabismus Surgery

Summary: strabismus, characterized by a misalignment of the eyes, is a common condition that can result in functional and cosmetic issues, often affecting vision and binocular coordination. strabismus surgery aims to correct the alignment by adjusting the extraocular muscles, but while the primary goal of surgery is to restore ocular alignment, refractive changes may occur as a secondary effect (1). the traditional view of strabismus surgery is that it is more difficult to plan than to perform. nevertheless, some complications sometimes have some clinical significance and may affect the visual acuity, physical appearance, and future life of the patients (2). refractive changes are among the complications of strabismus surgery. this is mostly attributed to the fact that surgical interventions to the extraocular muscles change the vectorial forces transmitted to the cornea via the scleral pathway (3). other theories on this subject include postoperative scleral wound healing, edema in the orbit and eyelids, change in ciliary body blood flow, and change in crystalline lens shape and curvature. in addition, if the anterior ciliary arteries are damaged during strabismus surgery, the supply of the anterior segment may be disrupted and changes in parameters may occur accordingly (4). also, surface tension changes in adjacent tissues due to changes in muscle tension after surgery may result in changes in corneal and anterior segment measurements (5). the timing of refractive changes after surgery also varies. some patients experience changes in their refractive status shortly after surgery, while others may develop these changes months or even years later. this delayed onset can make it more challenging to identify the precise cause of the refractive shift, as it may not always be immediately apparent following the initial surgical correction (6). research shows that post-strabismus surgery can result in myopic shifts, especially in patients with esotropia, and hyperopic shifts in exotropia. astigmatism can also develop due to corneal shape changes. preexisting refractive errors, age, strabismus type, surgical technique, and surgeon experience also influence post-surgical changes . to investigate the refractive changes that occur following strabismus surgery, with a focus on identifying the type and timing of refractive shifts (such as myopia, hyperopia, or astigmatism) and their association with the type of strabismus and surgical technique used.


Eligibility criteria:
inclusion criteria: * all patients diagnosed with concomitant strabismus requiring surgical correction. * clear ocular media. exclusion criteria: * patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology). * patients who have undergone previous intraocular or strabismus surgeries.
fructose rich diet and endothelial function

Conditions: Fructose Metabolism Disorder; Fructose Rich Diet; Metabolic Disease; Aerobic Exercise

Summary: cardiometabolic diseases have been associated with high consumption of sweetened beverages. these products are responsible for the largest portion of the total consumption of fructose in the diet and it is suggested that excessive intake of this monosaccharide may contribute to the development of risk factors for these diseases due to differences in metabolism relative to glucose. however, there is a lack of data in the literature demonstrating the deleterious effects of excessive fructose consumption on vasodilation and whether aerobic training may be able to prevent or mitigate these damages in humans. therefore, the aim of the study will be to verify the effect of 4 weeks of high fructose diet associated with aerobic training on uric acid levels and its influence on markers related to oxidative stress and vasodilatation. twenty-one sedentary men and women, aged between 19 and 35 years, will be submitted to 4 weeks of intervention. in a randomized way, subjects will be divided into 3 groups: high fructose diet, high glucose diet and high fructose diet and exercise. blood samples will be taken before, in the middle and after the intervention to verify the concentrations of uric acid, superoxide dismutase enzyme, thiobarbituric acid, nitrite / nitrate, lipid profile, glucose, insulin, c-reactive protein and endothelin-1. in addition, flow-mediated dilatation, insulin resistance index, pancreatic beta cell functional capacity index, oral glucose tolerance test, 24-hour blood pressure, heart rate variability and body composition will be analyzed. the comparisons will be performed through the generalized estimates of equations, adopting the factors group and time. the bonferroni post-hoc will be used to identify differences. the accepted level of significance will be 5%.


Eligibility criteria:
inclusion criteria: * men and women; * not engaged in regular exercises; * aged between 19 and 35 years; * body mass index (bmi) of less than 30kg / m². exclusion criteria: * individuals with bmi below 18kg / m² and greater than 30kg / m²; * smokers; * dyslipidemic; * diabetic; * hypertensive; * alcohol use; * appetite suppressants use; * medications use; * supplements use; * chronic disease that impedes the performance of physical exercise.
arterial thrombosis and inflammatory bowel disease: a series of 6 cases and literature review

Conditions: Arterial Thrombosis

Summary: vascular complications in patients with inflammatory bowel disease (ibd), comprising mainly crohn's disease (cd) and ulcerative colitis (uc), representing 2% extra-intestinal complications. in over 60% of cases, these vascular complications of deep venous thrombosis (dvt) or pulmonary embolism (pe). several studies have shown that patients with ibd have a risk of venous thromboembolic disease (vte) increased from 1.5 to 3.5. this risk is closely related to disease activity.

vascular complications in patients with inflammatory bowel disease (ibd), comprising mainly crohn's disease (cd) and ulcerative colitis (uc), representing 2% extra-intestinal complications. in over 60% of cases, these vascular complications of deep venous thrombosis (dvt) or pulmonary embolism (pe). several studies have shown that patients with ibd have a risk of venous thromboembolic disease (vte) increased from 1.5 to 3.5. this risk is closely related to disease activity. however, the association between ibd and arterial thromboembolic events such as cases of myocardial infarction, stroke, aortic thrombus, mesenteric ischemia, peripheral arterial disease and members senior, was described less and remains a subject of debate. these arterial complications occur in young subjects accountability of ibd remains debated, and no clear pathophysiology. here the investigators describe a series of 6 cases of patients with ibd who developed severe arterial complications, and whose cause was retained digestive inflammatory underlying disease. this study is report of six (6) cases that will be described

Eligibility criteria:
inclusion criteria: * patients with arterial thrombosis and inflammatory bowel disease admitted in paris saint joseph hospital exclusion criteria: * no exclusion criteria
three-level network rehabilitation model

Conditions: Stroke; Primary Medical Care

Summary: the objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. the main question it aims to answer are: whether the intervention mode of integrated chinese and western medicine is more valuable to implement. researchers randomly assigned 90 patients to either group a or group b, 45 in each group. group a adopted the conventional three-level rehabilitation model; group b adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of chinese and western medicine. fugl-meyer motor score was used to assess the patient's motor ability, berg balance scale was used to assess the patient's balance ability, national institute of health stroke scale was used to assess the patient's neurological function, and modified barthel index was used to assess the patient's ability of daily living.


Eligibility criteria:
inclusion criteria: * patients whose primary disease is stroke, whose diagnosis conforms to the "chinese and western medicine emergency diagnosis and treatment expert consensus for acute ischemic stroke"; * confirmed by imaging mri or ct; * hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop. exclusion criteria: * patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past; * patients with lumbar spine or sacral spinal stenosis in the past; * patients with previous epilepsy; * patients with previous history of stroke; * patients with heart and renal failure; * patients who cannot cooperate with treatment.
endoscopic resection of papillary adenomas; a novel treatment algorithm to prevent recurrence - a pilot-study

Conditions: Ampullary Adenoma

Summary: recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). this leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. recurrences most likely originate from either the biliary orifice or lateral resection margins. ablative methods such as radiofrequency ablation (rfa) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. however, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed.

recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). this leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. recurrences most likely originate from either the biliary orifice or lateral resection margins. ablative methods such as radiofrequency ablation (rfa) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. however, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. it is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (stsc) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension

Eligibility criteria:
inclusion criteria: * papillary adenoma which seems suitable for curative endoscopic resection. * 18 years or older. * capable of providing written and oral informed consent. exclusion criteria: * patients with intraductal extension of \>1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.(16) * failure to place a pd stent in patients with normal pancreatic duct anatomy. * refusal to provide informed consent.
adrenomedullin in context with pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the pulmonary embolism (pe) causes a blockade of the pulmonary arteries typical due to a thrombus which is formed in the lower region of the body or pretty rare to other materials (tumor, air, fat). the working group plans to evaluate the pathology of the thromboembolism in the case of a partial, subtotal or even total pulmonary embolism. the acute pe is still often in the adult population and in many accompanied by death. etiological the problem occurs through an acute right ventricular failure and leads into severe pulmonal perfusion disorder with shock and hypoxemia. the right diagnose is pretty hard in the clinical day because all symptoms are common and unspecific. to provide the best treatment in short time it is needed to sum up all the symptoms and evaluate the risk of an acute pulmonary embolism and it's morbidity. the easiest and fastest way treating a pe is to apply a systemic intravenous thrombolysis but bleeding complications are the most common and most frequently side effects. the decision-making process in patients without shock is pretty hard because of having no clear diagnose. lab parameters and imaging (ct angiography) is important for the best decision in critical ill pe patients but time is sometimes missing. a possible new biomarker in identifying a pe is adrenomedullin. elevated adenomedullin levels in septic patients with left ventricular heart failure, severe dyspnoea and intubated patients are well known, but in the case of pe it wasn't analysed yet. human adrenomedullin is a protein with 52 amino acid which is produced in the lung and first extracted in the adrenal gland. the sequence homology is pretty similar to the calcitonin-gene-related-peptide (cgrp)-protein superfamily (vasodilatation). its precursor is named pro-adrenomedullin peptide and it shows a significant weaker vasodilatation activity compaired to adrenomedullin. adrenomedullin causes severe hypotonia in scientific studies where it was applied as an intravenous bolus or infusion. this vasodilatation effect concern to the systemic and as well in the pulmonary circulation. its vasodilatation mechanism is not clarified yet. the trial is defined as an prospective study, where the investigators would like to measure/analyse the adrenomeulline level in pe patients in the intermediate high and high risk population. the diagnose and treatment of the patients is fixed to the european society of cardiology (esc) recommendations of the cardiology society of 2019 guidelines on acute pulmonary embolism (diagnosis and management of pulmonary embolism).


Eligibility criteria:
inclusion criteria: * patients with intermediate high and high risk of an acute pulmonary embolism with clinical symptoms. * on image based procedures confirmed pulmonary embolism (tte, contrast ct-angiography). * written agreement to the examination. exclusion criteria: * age under 18. * missing written agreement or cancelled agreement on any time.

Keywords: pulmonary embolism adrenomedullin biomarker