Kornimate/medical-research-clean huggingface dataset:
poem vs. pneumatic dilation for esophageal achalasia

Conditions: Esophageal Achalasia

Summary: the purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (poem) compared with pneumatic dilation in the treatment of esophageal achalasia.

esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (les). the major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food. currently, treatment options mainly focus on relief of the symptoms by reducing the les pressure. pneumatic dilation is the main endoscopic therapies for esophageal achalasia. however, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). for surgery approaches, the laparoscopic heller's myotomy (lhm) combined with dor's antireflux procedure has gained considerable interest. the lhm can sustain therapeutic effects for long-term in approximately 80% of patients. recently, inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (poem) and achieved promising results in short-term. technically, poem derived from natural orifice transluminal endoscopic surgery (notes) and endoscopic submucosal dissection (esd), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction. however, the long-term efficacy and safety of poem were not determined, and there was no prospective study that compared the poem with other conventional treatment. therefore, we aim to determine the efficacy and safety of poem, compared with the pneumatic dilation, in the treatment of esophageal achalasia.

Eligibility criteria:
inclusion criteria: * between 18 and 75 years of age * patient with esophageal achalasia * eckardt score \> 3 * signed informed consent exclusion criteria: * severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk * pseudo-achalasia, mega-oesophagus (greater than 7 cm), or oesophageal diverticula in the distal oesophagus * previous endoscopic botox injection * previous oesophageal or gastric surgery * pregnancy or lactation women, or ready to pregnant women * not capable of filling out questionnaires

Keywords: esophageal achalasia peroral endoscopic myotomy poem pneumatic dilation
meditation and kundalini yoga for heightened anxiety related to covid-19

Conditions: Generalized Anxiety; Health Anxiety

Summary: this randomized clinical on-line study examines whether whether a daily practice of meditation or kundalini yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.

the individual and societal costs of the covid-19 pandemic are wide-ranging. based on past epidemics and on emerging data, anxiety and depression rates will increase, along with anger, grief, somatic complaints, and post-traumatic stress. coping skills will be challenged, particularly as anxiety, uncertainty, and personal loss increase. while anxiety is a healthy response to danger, excessive anxiety can be debilitating and impair our coping skills. illness anxiety may also increase given concerns about infection risks to self and others. this randomized on-line study is for individuals with anxiety and distress triggered by covid-19 who have not yet been infected with the novel corona virus. . the primary study goal is to examine the extent to which anxiety can be reduced through the use of on-line training programs. all participants will receive anxiety reduction training using cognitive-behavioral methods known to be helpful in reducing stress, anxiety, depression, and insomnia. in addition, two-thirds of participants will be randomly assigned to receive training in either kundalini yoga (ky) or mindfulness meditation. the investigators will assess the degree to which each of these training programs lead to reduced stress, improved well-being, decreased multisystem symptoms, enhanced mood, and reduced cognitive complaints. participants will complete self-report assessments at 2-week intervals during the 8 weeks of the acute phase of the study and then again 3- and 6-months later. the current study may reveal that addressing emergent anxiety early through online self-guided treatment approaches can lead to improved short- and long-term outcome. findings from this study may reveal that these inexpensive easily disseminated on-line programs can be helpful to enhance coping and improve mental health in the context of large-scale public health crises.

Eligibility criteria:
inclusion criteria: 1. heightened anxiety triggered or exacerbated by covid-19 2. anxiety it least mild-moderate in severity 3. english speaking and living in the united states 4. access to a smart phone, tablet, or computer with internet 5. able to read and understand english exclusion criteria: 1. individuals with severe depression or substance abuse 2. individuals with a current or past history of psychosis, bipolar disorder, or ptsd. 3. individuals with physical disability that might make study participation difficult. 4. individuals with an unstable medical illness or a history of cardiac disease 5. individuals with a current daily practice of meditation or kundalini yoga 6. individuals with confirmed or suspected covid-19 7. individuals who are currently pregnant or anticipate being pregnant during study
the circumvent project: a cpap/o2 helmet solution for non-invasive ventilation among patients with covid-19

Conditions: SARS-CoV-2 Acute Respiratory Disease; COVID-19 Respiratory Infection

Summary: the purpose of the circumvent project is to evaluate the feasibility, adaptability and acceptability of a cpap/o2 helmet solution for non-invasive ventilation among patients with covid-19 and health workers in eight covid-19 treatment and isolation centers in nigeria.

acute respiratory failure, a major cause of death in covid-19, is managed with high-flow oxygen therapy via invasive mechanical ventilation. in resource-limited settings like nigeria the shortage of ventilators and oxygen supply make this option challenging. evidence-based non-invasive alternatives to mechanical ventilation such as the use of continuous positive airway pressure (cpap) devices exist, but there have been concerns that non-invasive ventilation may expose healthcare workers to infection from aerosolized dispersion of sars-cov-2. the investigators propose to evaluate the feasibility, adaptability and acceptability of a cpap/o2 helmet solution for non-invasive ventilation among patients with covid-19 and health workers in eight covid-19 treatment and isolation centers in nigeria. the study will occur in 4 stages: 1) convene a steering committee of key stakeholders and recruit implementation sites; 2) use the integrated promoting action on research implementation in health services (i-parihs) framework to guide a needs assessment of treatment centers' capacity to use high-flow oxygen therapy to treat covid-19 patients, and utilize the findings to develop an implementation strategy for use of cpap/ o2 helmet solution; 3) build infrastructure to support training and data monitoring processes and to develop implementation protocols to evaluate the adaptability of the strategy for the use of the cpap/o2 helmet; and 4) train health workers, distribute a cpap/o2 helmet solution for non-invasive ventilation, pilot test the implementation strategy, and assess feasibility of its use and acceptability that includes monitoring altered risk of sars-cov-2 infection among healthcare workers.

Eligibility criteria:
inclusion criteria: * adult patients admitted to a study site with respiratory distress and suspected or confirmed covid-19 infection exclusion criteria: * patients who do not meet eligibility criteria

Keywords: non-invasive ventilation implementation science
effect of left atrial appendage excision on procedure outcome in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation

Conditions: Atrial Fibrillation

Summary: the aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility criteria:
key inclusion criteria: * patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation * signed inform consent key exclusion criteria: * paroxysmal atrial fibrillation * contraindications for surgical ablation * unwilling to participate

Keywords: atrial fibrillation ablation thoracoscopy left atrial appendage
whey protein supplementation in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: many dietary supplementations are available to help people in balancing the protein intake and overcoming muscle mass loss. however, most of the products contain protein and could potentially affect levodopa action in people with parkinson's disease (pwpd). the study aims at verify if whey protein supplementation interferes with dopamine replacement therapy efficacy in pwpd admitted at the clinic for a four weeks intensive multidisciplinary rehabilitation training.

authors performed a randomised single blind monocentric study on pwpd admitted in the rehabilitative unit of the moriggia pelascini hospital for a 4-week multidisciplinary intensive aerobic rehabilitation treatment. all patients received a standard protein redistribution dietary regimen plus a whey protein-based oral formula (n=26) or magnesium (n=25) twice daily for 28 days. neurological assessment and physical evaluation were conducted before (t0) and after (t1) rehabilitative treatment; dopamine replacement therapy was recorded t0 and t1 as well. the delta of changes within groups in neurological (updrs iii) and physical (tug, 6mw) evaluation scales was compared between groups.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease (ukbb criteria hughes et al., 1992), * h\&y stage 2 or 3 * presence of motor fluctuations (by means of updrs iii item 4.3≥1) exclusion criteria: * cognitive decline

Keywords: levodopa whey protein supplementation aerobic rehabilitation
clinical effectiveness of ireadmore for people with alexia

Conditions: Stroke; Brain Injuries; Aphasia; Alexia; Dementia

Summary: ireadmore will provide an app-based therapy for people with pure or central alexia. this study aims to test the clinical effectiveness of ireadmore for improving reading accuracy and speed in real world users of the therapy.

ireadmore is a self-led therapy app for improving single word reading accuracy and speed in individuals with acquired reading impairments. ireadmore has been demonstrated to improve reading speed and accuracy in pure and central alexias (woodhead et al., 2013, 2018). ireadmore therapy is not expected to improve reading for the remaining alexia subtypes. ireadmore includes 590 of the most frequently written words from the subtlex lexical database (brysbaert and new, 2009). high frequency words were chosen to maximise the relevance (ecological utility) of the training to everyday life. the therapy mechanism relies on mass practice of cross-modal, paired associate learning (holcomb and anderson, 1993) based on the triangle model approach to reading. untrained words will not be affected, and thus word reading improvements are not expected to generalise beyond trained items. the therapy utilises gamification and is designed to be accessible in order to drive motivation and engagement for the user group. ireadmore is downloadable via the google play store on android tablet devices. ireadmore is a ce-marked class 1 medical device that was developed by the neurotherapeutics group, university college london. an online roll-out trial will be conducted to evaluate the clinical effectiveness of ireadmore with a study population of real world users. the therapy will be evaluated in a clinical population with a reading impairment of any acquired cause (such as stroke or brain injury). participants will self-enrol in the study through the app, which has been co-designed to ensure accessibility to this user group. a within-participant evaluation of trained versus untrained items will investigate the clinical effectiveness of the therapy for improving reading speed and accuracy. the primary outcomes are improvements in single word reading accuracy and speed. interval testing will be conducted after every 5 hours of therapy. the secondary outcomes are self-reported activities of daily living and a series of qualitative questions. further analyses will be conducted on alexia subtypes and the influence of therapy dose and intensity on the therapeutic outcomes. ethical approval for the ireadmore roll-out trial was obtained from the ucl research ethics committee (id: 7609/001).

Eligibility criteria:
inclusion criteria: * over 18 years old * diagnosed with stroke, dementia, brain injury or brain tumour * diagnosed or self-diagnosed with impaired reading ability * willing and able to give informed consent for participation in the study exclusion criteria: * history of developmental reading or speech and language disability

Keywords: digital therapy reading disorder alexia dyslexia rehabilitation
light based analysis of developing breast tissue in adolescent girls: a feasibility study

Conditions: Breast Cancer

Summary: the proposed pilot study attempts to investigate the feasibility of optical spectroscopy (os) as a method to quantify breast tissue composition and density in adolescent females. our goals include: to assess whether adolescent girls can be instructed to assist with the os measurement procedure and to determine the os technique's ability to show breast tissue composition and density in adolescent breast tissue.

the period between menarche and the age of first full-term pregnancy has been identified as being most crucial for establishing an individual's future breast cancer risk. epidemiological studies further suggest exposures, such as foods and toxins, during adolescence to have a significant impact on the likelihood of transformation in the developing breast resulting in cancer later in life. adolescent diet affects mammary development directly and indirectly by influencing the micronutrients and the hormonal status of the adolescent. the goal of this study is to investigate the feasibility of optical spectroscopy (os), a method based on differential light scattering and absorption in tissue, to quantify bulk breast tissue properties in adolescent females.

Eligibility criteria:
inclusion criteria (girls): * are in good health and are able to provide assent * are between the ages of 10 and 14 * are interested in participating in this study * are willing to come, accompanied by a parent, to the princess margaret hospital inclusion criteria (parents): * are able to provide consent * are willing to accompany your daughter to the princess margaret hospital for one visit of about 45 minutes exclusion criteria (girls): * have had previous surgeries to the chest area

Keywords: optical transillumination spectroscopy breast cancer risk
investigating the feasibility of a physical activity (tele)coaching intervention in patients with non-small cell lung cancer: an explorative study

Conditions: Non-small Cell Lung Cancer; Non-small Cell Carcinoma

Summary: the aim of this study is to investigate the acceptability, actual usage, feasibility and safety of 1) a (semi) automated pa tele coaching intervention including smartphone application and stepcounter (fitbit charge 4) and 2) a manual pa tele coaching program using only a stepcounter (fitbit charge 4) without custom smartphone application but still linked with a smartphone using the fitbit application and to make population specific adaptations to the intervention for patients with nsclc after lung resection surgery.


Eligibility criteria:
inclusion criteria: * three to nine months after a lung resection surgery for non-small cell lung cancer * if patients received adjuvant chemotherapy, the inclusion window will be three months to nine months after the end of adjuvant chemotherapy * adults (+18 year) exclusion criteria: * progressive or recurrent lung cancer * who had other malignancies in the last 2 years * psychiatric disorders * other ongoing treatments * involved in or planned to start a multidisciplinary rehabilitation program * unable to learn to work with a new electronic device (e.g. smartphone) * not understanding and speaking dutch * patients with comorbidities precluding them from participation in a physical activity intervention
gallant 5 tesaglitazar versus metformin

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. the study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are ³18 years of age * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Keywords: type 2 diabetes
safety and efficacy of dinoprostone (propess) in the women with premature rupture of membrane or gestational age <38

Conditions: Induction of Labor

Summary: dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. the investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or ga\<38weeks


Eligibility criteria:
inclusion criteria: * pregnant women who admitted for induction of labor * bishop score \<= 6 exclusion criteria: * contraindication to induction of labor * active labor * vaginal bleeding, unknown origin * hypersensitive to prostaglandin e * history of asthma, glaucoma * infection (birth canal) * placental abruption * multiparity(\>5) * pelvic inflammatory disease * heart, lung, kidney disease * multiple pregnancy * major anomaly * fetal distress before induction of labor
brief psychotherapies for emotional disorders in primary and secondary care

Conditions: Emotional Disorder

Summary: the present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. the investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the primary or secondary care context to improve the patient´s quality of life.

nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. so-called "emotional disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. however, research indicates that psychological treatment should be the first step when caring for these types of problems. the investigators expect that the results show that brief psychological therapies are more effective than pharmacological interventions. moreover, it is expected that brief individual psychotherpay approach delivered in secondary care is more effective than brief group psychotherapy delivered in primary care.

Eligibility criteria:
inclusion criteria: * emotional disorder exclusion criteria: * severe mental disorder * substance use disorder * severe depression
a study of vedolizumab in adults in real-world practice

Conditions: Colitis, Ulcerative; Crohn Disease

Summary: vedolizumab is a medicine that is currently prescribed for adults with moderately to severely active ulcerative colitis or crohn's disease. in this study, adults with ulcerative colitis or crohn's disease will be treated with vedolizumab according to their clinic's standard practice. the main aim of the study is to check if participants have side effects from vedolizumab. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

this is a non-interventional, prospective study of participants with uc or cd who are prescribed and will start vedolizumab in the real word setting for the first time. this study will evaluate the safety and effectiveness of vedolizumab in a routine clinical practice setting under real world conditions. the study will enroll approximately 500 participants. the data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic data capture (edc). all participants will be enrolled in a single observational group: • participants with uc or cd this multi-center trial will be conducted in china. the overall duration of the study will be approximately 72 weeks.

Eligibility criteria:
inclusion criteria: 1. diagnosed with uc or cd 2. firstly prescribed with vedolizumab exclusion criteria: 1. currently enrolled in or plan to participate in any other clinical trials (that is, interventional study) 2. contraindicated for vedolizumab according to product package insert

Keywords: drug therapy
in vitro analysis of effluent dialysate solution from patients on peritoneal dialysis, with the cloudcath device

Conditions: Peritoneal Dialysis-associated Peritonitis; End Stage Renal Disease

Summary: a proof-of-concept study of a prototype cloudcath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen. * specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient. * specimens shall not contain any individually identifiable information from the patient it was obtained from. exclusion criteria: * patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis. * patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer. * patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.