Kornimate/medical-research-clean huggingface dataset:
patient experiences of multiple sclerosis (pexms)

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Patient Engagement; Self Efficacy

Summary: besides coping with the diagnosis, people with multiple sclerosis have to make complex decisions such as deciding about immunotherapies. they search not only for factual information, but also for reports of patient experiences (pex). the investigators aim to evaluate in a randomised controlled pilot trial whether a website presenting pex as an adjunct to factual information may help people with multiple sclerosis in their immunotherapy decision-making processes.

a variety of management options (e.g. immunotherapies, lifestyle interventions, and rehabilitation) are available for people with relapsing-remitting multiple sclerosis. besides coping with the diagnosis, people with multiple sclerosis have to make complex decisions such as deciding about immunotherapies. in addition to factual information, reports of patient experiences (pex) may support patients in decision-making. the added value of pex in decision-making is not clear and controlled studies are rare. therefore, systematic methods are necessary in order to develop and analyse pex. as there are no evaluated pex for multiple sclerosis in germany, the investigators are currently creating a website presenting pex structured according to topics and illustrated by video, audio and text files. the investigators aim to evaluate whether pex may help people with multiple sclerosis in their immunotherapy decision-making processes. this project will follow the medical research council framework for development and evaluation of complex interventions. after the development of a website with pex, a randomised controlled pilot trial will be conducted in five neurological practices/clinics including 55 people with relapsing-remitting multiple sclerosis and accompanied by a process evaluation. participants will be randomly assigned either to i) an intervention group with a two weeks access to an evidence-based patient information resource and the pexms-website as an adjunct or to ii) the control group with access to evidence information alone. a 6-members advisory panel involving representatives of people with multiple sclerosis, researchers, and neurologists, who accompany the whole project will mentor this pilot rct. the ethical committee of the hamburg chamber of physicians approved the study protocol.

Eligibility criteria:
inclusion criteria: * persons with relapsing-remitting multiple sclerosis * being ≥18 years old * considering starting, switching or stopping any immunotherapy exclusion criteria: * persons with secondary progressive multiple sclerosis or primary progressive multiple sclerosis * persons with major cognitive deficits * persons having poor german language skills * persons who participated in the development phase of the pexms-website, which took place prior to the pilot randomised controlled trial

Keywords: multiple sclerosis decision making decision support web-based experiential information patient experiences narrative information
post marketing surveillance of telostop tab (telmisartan/rosuvastatin) for evaluating the safety and efficacy

Conditions: Hypertension; Dyslipidemias

Summary: post-marketing surveillance of telostop tab (telmisartan/rosuvastatin)

telostop tab is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the republic of korea for the treatment of patients with hypertention and dyslipidemia. a post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of telostop tab in real-world practice.

Eligibility criteria:
inclusion criteria: * the patient who is first prescribed and administered telostop plus tab. exclusion criteria: * the patients who are overreacting to this drug or its components * the patients to the "do not administer to the next patient" section of the approved instructions for use
acute pain management following video-assisted thoracoscopic surgery: comparison of lobectomy and wedge resection

Conditions: Postoperative Pain

Summary: viedo-assisted thoracoscopic surgery(vats) have became popular in recent years. there is no golden rule of postoperative analgesia for vats. compared with lobectomy, wedge resection preserves better pulmonary function and is suitable for elder patients and patients who could not afford to have lobectomy. in addition to surgery time、recovery time and hospital stay, wound incisions and organization damages are different,too. will patients also have different response to pain control after these two surgery? the retrospective study is to compared the differences of postoperative pain management between vats lobectomy and wedge resection.


Eligibility criteria:
inclusion criteria: 1. age \>= 20 2. using intravenous patient-controlled analgesia for postoperative analgesia 3. asa physical status classification i-iii exclusion criteria: 1. staying in intensive care unit after surgery 2. emergency surgery 3. pregnancy 4. other surgery incisions which are not used for the video-assisted thoracoscopic surgery 5. patients never use intravenous patient-controlled analgesia after surgery
laparoscopic cholecystectomy or conservative treatment in the acute cholecystitis of elderly patients

Conditions: Cholecystitis, Acute

Summary: cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.the purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.

the increasing age is one of the main risk factors for developing complicated gallstone disease. currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis. aim: the purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis. study design: multicenter randomized controlled trial (rct) and additional cohort of all elderly patients (\>75 years old) with acute cholecystitis. patient allocation: elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. reasonably healthy elderly patients (asa 2-3) are included in this study, excluding the patients with asa-class above 4. interventions: the study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. the control group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later. primary outcome: assessment of morbidities related to acute cholecystitis and individual quality of life. secondary outcomes include number of hospital admissions, length of hospitalization, pain, complications, mortality and cost analysis. sample size and data-analysis: based on data of previous studies the recruitment of 200 patients in total is expected. follow-up will be for 12 months. in addition of rct, we decided to record and analyze all acute cholecystitis of elderly patients in study hospitals during the study period. we will present these results in the connection of rct analysis.

Eligibility criteria:
inclusion criteria: * radiologically confirmed acute cholecystitis * age over 75 yrs * american association of anesthesiologists classification class 2-3 * duration of symptoms \< 5 days exclusion criteria: * american association of anesthesiologists classification class 4-5 * age under 75 yrs * peritonitis * sepsis or septic shock * duration of symptoms over 6 days * cholestasis or diagnosed stone at common biliary duct. * acute pancreatitis
a study to assess the efficacy and safety of solriamfetol in subjects with adhd (focus)

Conditions: ADHD

Summary: focus (forward treatment of attention deficit and hyperactivity using solriamfetol) is a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with adhd.

eligible subjects must have a primary diagnosis of adhd based on the diagnostic and statistical manual of mental disorders fifth edition (dsm-5) criteria. subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, or placebo, once daily for 6 weeks.

Eligibility criteria:
inclusion criteria: * primary diagnosis of adhd according to dsm-5 criteria. * provides written informed consent to participate in the study before the conduct of any study procedures. * male or female, aged 18 to 55 inclusive. exclusion criteria: * prior exposure to solriamfetol/sunosi, through either a clinical study or prescription. * unable to comply with study procedures. * medically inappropriate for study participation in the opinion of the investigator.

Keywords: attention deficit hyperactivity disorder adhd solriamfetol sunosi axsome non-stimulant therapy dopamine norepinephrine reuptake inhibitor
covid-19, aging, and cardiometabolic risk factors study

Conditions: Covid19; Obesity; Diabetes Mellitus; Aging; Cardiometabolic Syndrome; Immune System Disorder

Summary: covid-19 pandemic has made a tremendous impact on indonesian economic and health care system especially with the double burden of diseases facing by indonesia as a developing country. the prevalence of non-communicable diseases such as obesity, type diabetes, and cardiovascular diseases is increasing. these diseases along with older age have been known as an established risk factors for higher mortality and severe clinical disease entity in covid-19 infection. although, there is still some part of patients with these co-morbidities that only present with mild symptoms when infected with sars-cov-2, even for some without any symptoms. thus, it would be very interesting to evaluate how are these role of aging and cardiometabolic parameters in the clinical disease course of covid-19 infection, and how are the relationship with the immune system.

indonesia is a country in transition where the burden of non-communicable diseases is taking over the infectious diseases problem, mostly due to the changes in lifestyle and increase in life expectancy. however, the unprecedented rising numbers of covid-19 patients in indonesia has impacted the indonesian healthcare system heavily. it has been reported that older age and the presence of cardiometabolic risk factors pose a poor prognostic factor of covid-19. it is also important to note that in indonesia, the presence of cardiometabolic risk factors is often observed at a younger age. thus, this might also contribute to the higher mortality of covid19 infected patients despite their relatively younger age in comparison to other countries. nevertheless, specific data on the impact of aging and cardiometabolic risk factors on covid-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. the caramel study aims to specifically describe the phenotypic aging and cardiometabolic characteristics of patients with covid-19 infection, in relation with the changes in the mucosal and systemic immune system. particular attention will be devoted to obesity, central obesity, prediabetes, diabetes, hypertension, dyslipidemia, as well as anti-diabetic, antihypertensive, and anti-dyslipidemia therapies. this study will provide answers to researchers, medical professionals, and especially patients, regarding the impact of aging and cardiometabolic risk factors for covid-19 prognosis. this pilot study will be used for the development of new studies and for the establishment of recommendations for the care of patients with cardiometabolic risk factors and covid-19.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed with covid-19 at hospital setting or community screening, confirmed with biological proof (rt-pcr) exclusion criteria: * subjects opposed to the use of their data * minors, adults under guardianship, protected persons * history of malignancy * history of autoimmune disease * pregnancy

Keywords: covid-19 adiposity diabetes insulin resistance aging inflammation immune system
clinical study of the treovance stent-graft for patients with abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm (AAA)

Summary: the purpose of this clinical trial is to assess and evaluate the safety and efficacy of the treovance stent-graft with navitel delivery system in subjects with abdominal aortic aneurysms (aaa).

this is a phase ii, multi-center, non-blinded, non-randomized study of treatment with the treovance stent-graft in subjects with abdominal aortic aneurysms. the study will include 150 subjects treated with the treovance stent-graft at a maximum of 30 investigational sites. there will be no prospective control group. subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the treovance stent-graft with navitel delivery system. pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. in addition, annual follow-up visits out to 5 years will be conducted. the primary goal of this study is to gather safety and effectiveness data on the treovance device. a maximum of 150 endovascular subjects will be required to fulfill the u.s. phase ii requirements. the data from this study will be submitted to the fda and used to support approval in the u.s. there are two primary objectives, efficacy and safety of the treovance stent-graft in subjects with infrarenal aortic aneurysms: * primary efficacy will be evaluated by successful aneurysm treatment 12 months post-implant * primary safety will be assessed by composite major adverse event (mae) rate at 30-days secondary objectives involve assessment of major device-related events and major morbidity.

Eligibility criteria:
inclusion criteria: * subject must be diagnosed with an infrarenal abdominal aortic aneurysm (aaa), with or without iliac artery involvement * subject must have an infrarenal aaa that is \> 4.5 cm in diameter for males, or \> 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months exclusion criteria: * subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician) * subject has had a prior aaa repair (endovascular or surgical) * subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure

Keywords: abdominal aortic aneurysm aaa aneurysm
lemon verbena extract oxidative stress and muscle damage

Conditions: Muscle Injury; Muscle Soreness

Summary: in the present study, investigators investigated whether supplementation with lemon verbena extract (lve) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. based on maximum jump heights, 60 subjects (30 males and 30 females) were equally divided into a placebo group (0 mg/human/day) and an lve supplement group (400 mg/human/day), with gender-equal distribution. all subjects started supplementation 10 days before exhaustive exercise and continued it until all tests were completed. before the intervention, after the exhaustive exercise, and on the following 3 days, the participants underwent 12-minute cooper running/walking; blood collection; assessments of pain, muscle stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic strength tests.


Eligibility criteria:
inclusion criteria: * health * must be able to swallow tablets exclusion criteria: * non-smokers * no musculoskeletal * medical * metabolic disease * women not on the reproductive cycle * high blood pressure, asthma * skeletal neuromuscular injuries in the upper or lower extremities

Keywords: doms, lemon verbena
the impact of vct and condom distribution as hiv prevention strategies among youth in kenya

Conditions: HIV/AIDS; HSV-2 Infection

Summary: the vast majority of new hiv infections occur in sub-saharan africa, where nearly 2 million people become infected with hiv/aids every year. forty-five percent of these new hiv infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of hiv. this research study aims to examine, through a large randomized controlled trial, the impact of two hiv prevention strategies among a youth population in kenya: voluntary counseling and testing for hiv (vct), and condom distribution.


Eligibility criteria:
inclusion criteria: youth previously participated in an earlier study by duflo, dupas and kremer in 328 primary schools in the same study site in western province, kenya who consent to participate. exclusion criteria: youth sampled for the study who do not consent to participate.

Keywords: youth kenya voluntary counseling and testing for hiv condoms hiv prevention hsv-2
effectiveness of the just right challenge food club for decreasing food selectivity and increasing mealtime quality

Conditions: Food Selectivity

Summary: this single subject study tested the effectiveness of the just right challenge food club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.

this study used a single subject design to test the effectiveness of the just right challenge food club for decreasing food selectivity and increasing mealtime quality for children with developmental disabilities. baseline data was collected during the time that participants spent on the wait list for treatment. treatment data was collected each week during treatment session. this protocol produced a significant change in both the number of foods the children in the study ate as well as the parents perception of mealtime quality.

Eligibility criteria:
inclusion criteria: * children who accepted less than 15 foods as part of their regular diet * children who refused whole food groups exclusion criteria: * children with life threatening food selectivity per parent report and physician referral information

Keywords: avoidant restrictive food intake disorder
whitsundays (nasal) singapore external clinical study 1 protocol

Conditions: Obstructive Sleep Apnea

Summary: each whitsunday mask or airfit n30i quiet mask is worn for 7 nights. the overall purpose of this study is to evaluate the performance of the whitsundays nasal mask system (a prototype mask) compared to the resmed airfit n30i quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.

this is a randomized, open label, cross over study to evaluate the whitsundays nasal mask system (prototype mask) against a released mask system, the resmed airfit n30i quiet mask system. the whitsundays nasal mask system will be compared with a released mask, resmed's airfit n30i quiet, as it is also a nasal mask and the most appropriate benchmark. study participants are experienced with cpap masks and devices and therefore will use their experience to identify areas for potential improvement. recruitment will be done via phone calls/ sms messages/ emails \ . participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit. visit 1: participants will provide written informed consent. participants will be shown the mask systems and trial them for fit and comfort. participants may be asked initial questions on their first thoughts on the mask systems. if the participant and assessor are happy to proceed, the participants will use the mask and loan cpap for trial. visit 2: after trialing the mask systems, participants will be asked to complete a questionnaire regarding the seal and comfort of the mask system(s). participants will then take the second mask system home to test. visit 3: the participant will return the masks and cpap device to the assessor. the participants' questionnaire responses will be reviewed. this concludes the participation in the study.

Eligibility criteria:
inclusion criteria: * patients willing to give written informed consent * patients who can read and comprehend english * patients who ≥ 21 years of age * patients being treated for osa with pap therapy for ≥ 6 months * patients currently using a suitable mask system (any nasal mask ) * patients who can trial the masks for up to 7 nights each exclusion criteria: * patients using bilevel flow generators * patients who are or may be pregnant * patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury. * patients believed to be unsuitable for inclusion by the researcher
the use of fes-pet imaging as a tool to detect a possible reversion of estrogen receptor (er)-α status in patients with metastatic breast cancer her2 + and erα neg treated with trastuzumab + pertuzumab + taxane.

Conditions: HER2-positive Breast Cancer

Summary: this is an exploratory, prospective and multicentric study aiming to highlight by fes-pet imaging that an anti-her2 treatment by trastuzumab + pertuzumab can reverse the erα status in patients with metastatic breast cancer her2 + and erα neg. for each included patient, 2 fes-pet imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the iuct-o center (institut universitaire du cancer de toulouse). treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center. patients will be followed during the 3 cycles of treatment.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patient with metastatic breast cancer her2 + (ihc+++ and/or her2 amplification in ish according to asco recommendations), erα neg (0% in ihc) and progesterone receptor neg (0% in ihc). 3. patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line. 4. available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone). 5. oms ≤ 2. 6. for non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study. 7. patient affiliated to a social health insurance in france. 8. patient must provide written informed consent prior to any study specific procedures. exclusion criteria: 1. any previous treatment for metastatic disease. 2. prior adjuvant treatment with anti-her2 antibodies taken within 6 months. 3. patient with isolated hepatic metastasis. 4. patient with hemostasis disorders. 5. unbalanced diabetes. 6. patient with usual formal contraindication to pet/tdm imaging. 7. patient who has already started trastuzumab + pertuzumab + taxane treatment. 8. pregnant or breastfeeding women. 9. any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure. 10. patient protected by law.

Keywords: metastatic breast cancer fes-pet her2-positive breast cancer