Kornimate/medical-research-clean huggingface dataset:
reducing arm morbidity in pre- and post-breast cancer surgery

Conditions: Breast Cancer

Summary: the overall aim of this pilot study is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (hrql) post-surgery.

breast cancer surgery is one of the most frightening health events a woman can experience. not only is there fear of cancer and mortality, but also fear of disfigurement and disability arising from the surgery and from the subsequent chemotherapy and radiotherapy. the pre-operative period is a time of great anxiety and in the post-operative period this anxiety is compounded by pain and discomfort associated with the breast and axillary wounds. lack of knowledge about follow-up treatment leads to fear and anxiety post-surgery. all women experience loss of mobility and function of the arm on the operative side for a period of time ranging from days to months to years. this arm morbidity interferes with participation in usual activities, is an additional source of stress compounding the psychological distress associated with the cancer itself, and has a negative impact on the quality of life. the post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. many women will be concerned about perturbing the healing process and may be depressed and anxious as they await extra treatment for the tumor. the pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery. the process of enhancing functional capacity of the individual to enable him or her to withstand stressors is termed "prehabilitation". this project deals with the effectiveness of prehabilitation with or without post-operative exercise to reduce arm morbidity and increase quality of life following breast cancer surgery. the overall aim is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (hrql) post-surgery. the specific objectives of this pilot project are to: 1. estimate recruitment rates for such a trial; 2. estimate compliance to the protocols; 3. pilot the randomization procedures; 4. identify sub-groups of the population with different needs for pre-and post-surgical physical therapy; 5. estimate effect sizes to be used for sample size calculations for the main project and for budget justification.

Eligibility criteria:
inclusion criteria: * women * diagnosed with breast cancer * able to complete questionnaires exclusion criteria: * none

Keywords: breast cancer prehabilitation rehabilitation exercise
enhancing modulation effects of baduanjin through neuromodulation for knee oa

Conditions: Knee Osteoarthritis

Summary: this study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. the findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.


Eligibility criteria:
inclusion criteria: * volunteers 45-75 years of age * meet the classification criteria of the american college of rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months; * physically able to participate in the bdj and stretching control education programs * willing to complete the 12-week study * can participate in mri scan * ability to read and understand english; english can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures exclusion criteria: * has performed bdj, tai chi, yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year * serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease * has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months * patient mini-mental status examination score below 24 \[293\] * unable to walk without a cane or other assistive device * the intent to undergo surgery during the time of involvement in the study * plan to permanently relocate from the region during the trial period
hcrn core data project: characterizing patient populations in the hydrocephalus clinical research network (hcrn)

Conditions: Pediatric Hydrocephalus

Summary: the hydrocephalus clinical research network (hcrn) has been established by philanthropic funding to conduct multi-institutional research (clinical trials and observational studies) on pediatric hydrocephalus. in addition to philanthropic funding, the hcrn has also received an nih ninds challenge grant to support the network infrastructure which allows for the conduct of this and other network studies. the hcrn consists of multiple clinical centers and the data coordinating center (dcc). the hcrn core data project will obtain data about all neurosurgical hydrocephalus events from the network clinical centers, and create a database to be used by hcrn investigators. the ongoing maintenance of the core data project serves two main purposes: 1) it will help investigators understand the variability, progression, and current treatment practices for hydrocephalus in children, with an ultimate goal of better guiding and assessing therapeutic intervention and providing recommendations on patient care and, 2) it will provide pilot and descriptive data necessary for hypothesis generation and study design (i.e. preliminary power analyses, recruitment projections) for studies under development by the hcrn. this multi-institutional database will be maintained throughout the lifetime of the hcrn, and may be useful for tracking trends in pediatric hydrocephalus over time. the core data project will be an invaluable resource to the hcrn and will help stimulate new research protocols, identify potential need for future expansion of the network to incorporate additional patient populations, and provide a descriptive understanding of children with hydrocephalus cared for within the network.


Eligibility criteria:
inclusion criteria: information for all neurosurgical hydrocephalus patient events will be obtained from each hcrn clinical center and will be placed continuously into the core data project. the first calendar year will be 2008, and data collection will continue for the duration of the existence of the hcrn. neurosurgical hydrocephalus patient events include any operation for the treatment of documented hydrocephalus including the following: * ventriculoperitoneal shunt * ventriculoatrial shunt * ventriculopleural shunt * arachnoid cyst shunts * subdural shunts * lumboperitoneal shunts * shunts replaced after treatment of infection * shunts exposed during an operations but not revised * endoscopic third ventriculostomies * ommaya reservoir(s) * ventricular access devices/reservoirs * subgaleal shunts. exclusion criteria: the following temporary cerebrospinal fluid (csf) diversion procedures will not be included in the core date project: • external ventricular drain(s)

Keywords: pediatric hydrocephalus
effect of the french version if the metagognitive bibliotherapy program "mymct" on obsessive-compulsive symptoms

Conditions: Obsessive-Compulsive Disorder

Summary: obsessive-compulsive disorder (ocd) is a psychiatric illness characterized by the presence of obsessions and/or compulsions. without effective treatment, symptoms tend to worsen and become chronic. international guidelines recommend medication and/or psychotherapy as the first-line treatment for ocd. however, the majority of sufferers remain undertreated worldwide. this lack of access to care worsened during the covid-19 pandemic. much of this suffering could be avoided by facilitating access to evidence-based therapies. as such, many distance therapeutic interventions have recently developed, such as bibliotherapy. these unguided self-help programs are mostly based on approaches derived from cognitive behavioral therapies (cbts). specialized metacognition bibliotherapy is more specifically based on the hypothesis of a cognitive meta-level that affects off-line knowledge and on-line self-regulatory behaviors. yet, the majority of ocd sufferers are reported to exhibit inadequate metacognitive processing. although these metacognitive abilities are often neglected in the ocd literature, they appear to play a significant causal role in the onset and maintenance of obsessive-compulsive symptoms. as a result, ocd-specific metacognitive treatments need to be developed to reduce symptomatology and improve quality of life for these patients. to date and to our knowledge, there is only one validated metacognitive bibliotherapeutic program for ocd. this manual is called "mymct: my metacognitive training". a recent meta-analysis confirms its effectiveness with 373 participants from germany, switzerland and russia in reducing obsessions and compulsions. although these results are promising, mymct did not exist in a french version until 2021. our team then translated the manual on a not-for-profit basis, and an independent translator at nice university hospital confirmed that it faithfully transcribed the meaning of the english version. this version has been freely available since november 2021 on the website of the department of psychiatry and psychotherapy at hamburg-eppendorf university medical center (https://clinical-neuropsychology.de/metacognitive-training-for-ocd-mymct/). the investigator propose to carry out a single-center randomized controlled research protocol concerning the effects of the french version of mymct in ocd patients. this clinical trial will be carried out́ in collaboration with professor moritz, author of mymct and renowned researcher.


Eligibility criteria:
inclusion criteria: * with ocd diagnosed by a psychiatrist, * unchanged psychiatric medication over the past 3 months, * have a good command of the french language, exclusion criteria: * person with a psychotic or bipolar comorbidity diagnosed by a psychiatric physician * person participating simultaneously in another clinical trial interfering with the results of the present study
clinical trial of safety and pharmacokinetics of vm-1500 after multiple oral administration in healthy volunteers

Conditions: HIV-infection

Summary: the purpose of the study to assess safety and tolerability of vm-1500 and to determine main pharmacokinetic parameters of vm-1500 after multiple oral administration in adult healthy subjects.

this is a randomized, double-blind, placebo-controlled, phase ib study in healthy volunteers with dose escalation to identify the optimal dosing schedule of vm-1500. a total of 36 subjects will be treated with the vm-1500 or placebo for 14 days with further follow-up for four weeks. subjects will be randomized into 3 cohorts with 3:1 drug/placebo ratio: cohort 1 (n=12): 10 mg vm-1500 for 9 volunteers, placebo for 3 volunteers; cohort 2 (n=12): 20 mg vm-1500 for 9 volunteers, placebo for 3 volunteers; cohort 3 (n=12): 30 mg vm-1500 for 9 volunteers, placebo for 3 volunteers; decision to escalate to the next (higher) dose will be made by the independent safety review board (isrb), established specifically for this study. isrb will base its decision on both the safety data obtained during drug administration in each cohort and analysis of clinical and lab data obtained within the course of the study. study time lines: * screening period - up to 30 days * treatment period - 14 days dosing (day 1-14) * 2 hospitalizations: day 1-3, day 13-15 * 28 pk samples in plasma: day1 - predose, 0,25; 0,5; 1; 1,5; 2; 3; 4; 8; 12 hours day 3, day 5, day 7, day 9, day 11, day 13 - before dosing day 14 (feed condition) - before dosing, 0,5; 1; 2; 4; 8; 12h day 16, day 23, day 30, day 37, day 44 pk in blood cells - day 1 (predose, 4h, 8h), day 3, 5,7, 9, 11, 13, 14 * post treatment follow-up period 30 days.

Eligibility criteria:
inclusion criteria: 1. provided signed written informed consent; 2. healthy male subjects, 18-50 years of age; 3. use of adequate and reliable forms of contraception during the study and 3 months after discontinuation of study medication. 4. icf signed prior to any study-related procedure. exclusion criteria: 1. hiv, hepatitis b, c antibodies in plasma; 2. clinical relevant laboratory abnormalities; 3. active tobacco, alcohol or drug abuse; 4. anticipated non-compliance with the protocol; 5. patients who have taken any investigational drug 3 months prior to the start of the study; 6. plasma donorship, surgery 12 weeks prior to the start of the study; 7. current significant gastrointestinal, renal, liver, bronchopulmonary, biliary, neurological, cardiovascular, oncologic, allergic, or ophthalmologic diseases, including history of cataracts/lens opacities.
a comparison between lumen-apposing metal stent and double-pigtail plastic stents for treatment of walled-off necrosis

Conditions: Walled-off Necrosis

Summary: walled-off necrosis (won) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. as the advances in endoscopic techniques and accessories, endoscopic ultrasound (eus)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (won). this article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.

according to the revised atlanta classification, pancreatic fluid collections (pfcs) include acute peripancreatic fluid collections(apfcs) and acute necrotic collections(ancs), which, over time, turn into pancreatic pseudocysts (pps) and walled-off pancreatic necrosis (won). drainage of these pp and won is required when they increase in size and become infected or become symptomatic. traditionally, won has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. in recent years, with the development of minimally invasive techniques, endoscopic ultrasound (eus)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (won). double-pigtail plastic stents(dpps) is the earliest stent used for won drainage in ultrasound endoscopy, however, these stents are limited by their small diameter leading to increased risk of stent obstruction. recently, lumen-apposing metal stents (lams) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. however, more adverse events(aes) such as bleeding have been reported. this article aims to compare the efficacy and safety of dpps and lams in the treatment of walled-off necrosis

Eligibility criteria:
inclusion criteria: * obtention of a written informed consent * according to revised atlanta classification, abdominal ct/mri and eus were diagnosed as won * the diameter of won ≥6cm * patient capable of fill in the quality of life questionnaire * the distance between the eus-probe and won was \< 1 cm. exclusion criteria: * no written informed consent * pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors * pancreatic pseudocyst * won too far from the stomach and duodenum to perform endoscopic drainage * serious abnormalities in liver and kidney function and coagulation function * pregnant, parturient or breastfeeding women

Keywords: endoscopic ultrasound guided drainage lumen-apposing metal stent double-pigtail plastic stents walled-off necrosis
thermosmart® versus conventional humidification in continuous positive airway pressure (cpap)

Conditions: Sleep Apnea, Obstructive

Summary: that thermosmart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. previous diagnosis of osa permitted, but patient must be novel to cpap and no previous surgical intervention for osa or treatment with an oral appliance. 3. ahi ≥ 15 or ahi ≥ 5 + ess ≥ 10 or ess ≥ 10 + a medical co-morbidity 4. patient willing to give informed consent and follow study protocol. exclusion criteria: 1. wake resting spo2 \< 90% 2. patient requires bilevel pap or supplemental oxygen 3. the patient is medically unstable (e.g. respiratory or cardiac failure) 4. patient unwilling to give informed consent or follow study protocol.

Keywords: obstructive sleep apnea humidification continuous positive airway pressure
efficacy and safety of insulin aspart in mdi or csii in children below 7 years of age with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 1 year * hba1c below 12.0% * treatment with regular human insulin and insulin nph for at least 1 month * receive more than 2 injections daily exclusion criteria: * receipt of investigational product within 6 months prior to trial participation * known or suspected allergy to investigational product * receipt of of insulin aspart within 3 months prior to trial participation
acute influence of resveratrol supplementation and beet extract in recovery after exercise in coronary paths

Conditions: Coronary Artery Disease; Autonomic Nervous System Disease; Blood Pressure; Heart Rate

Summary: introduction: most cardiovascular diseases (cvd) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. objective: to analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise recovery in coronary heart disease patients. methods: men diagnosed with ischemic coronary artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart rate reserve (hrr), followed by 25 minutes at intensity 60% of fcr and for a final 30 minutes of recovery in the supine position. before each exercise protocol, all volunteers will consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of each supplementation will be done randomly. cardiorespiratory parameters and heart rate variability (hrv) will be assessed at different times throughout the experimental procedure. to analyze the moments (rest versus recovery), the bonferroni post-test will be used for parametric distribution or the dunn post-test for non-parametric distribution. statistical significance will be calculated at 5% for all analyses.


Eligibility criteria:
inclusion criteria: * adult men over 45 years of age * diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram exclusion criteria: volunteers who present at least one of the following characteristics will be excluded: * smokers * alcohol drinkers * those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection * individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)
study to assess resource utilization and quality of life of patients with rrms treated with tecfidera in greece

Conditions: RRMS

Summary: this is a non interventional, multicenter clinical trial, in adult patients receiving tecfidera per approved smpc and routine clinical practice. the primary objective of this study is to evaluate the total societal costs to the healthcare system related to the use of tecfidera in rrms patients. the study will capture data in a simple matter that can be easily interpreted providing an advantage in a country where efforts in the market access arena are in their infancy. for the aforementioned reasons, the proposed study may prove quite valuable in supporting dmf as a cost-effective therapy, valuable not only for patients but for the public health care system as well, providing all the necessary information for the evaluation that need to be examined regarding the positive reimbursement list and future decisions.

the study will take place in greece. investigators will participate from a broad geographical distribution in order to ensure a proper representation from all areas of greece. investigator's decision to prescribe dmf (tecfidera®) (according to the indication for treatment as defined in the summary of product characteristics, smpc and the current clinical practice), should precede entry into the study.

Eligibility criteria:
inclusion criteria: * persons aged 18-65 years. * patients with a confirmed diagnosis of rrms. * patients for whom the decision to prescribe therapy with tecfidera®, according to the locally approved product's summary of product characteristics (smpc) has already been taken prior to their enrolment in the study. the assignment of a patient to this therapeutic strategy is not decided in advance, but falls within current practice, while the prescription of tecfidera® is clearly separated from the physician's decision to include the patient in the current study. * patients must have signed an informed consent document. * patients must be able to read, understand and complete the study specific questionnaire. exclusion criteria: * patients having other forms of ms, like clinically isolated syndrome (cis) or progressive forms. * patients who have initiated treatment with tecfidera® more than 7 days before study enrolment or have received dmf at any different time prior to this period. * patients that meet any of the contraindications to the administration of the study drug according to the approved smpc. * receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with tecfidera®.