Kornimate/medical-research-clean huggingface dataset:
the effects of telerehabilitation on muscle function, physical activity and sleep in cystic fibrosis during pandemic

Conditions: Cystic Fibrosis; Covid19; Social Isolation

Summary: the aim of this study is to evaluate the peripheral muscle function, sleep disorders and physical activity level in children with cystic fibrosis who are physically inactive at home due to social isolation and to examine the effect of the 6-week online exercise protocol.

considering the new coronavirus (covid-19) pandemic global information, some patient populations have been identified at higher risk of this pandemic like older age, hypertension, cardiovascular and respiratory diseases. self- isolation is recommended for preventive strategy in cystic fibrosis patients. long-term social isolation and school closure can have negative effects on childrens' physical and mental health. due to social isolation childrens are less physical active, have longer screen exposure and irregular sleep patterns. there is no study to evaluate the the peripheral muscle function, sleep disorders and physical activity level and examine the effects of exercise training in children with cystic fibrosis in social isolation due the covid-19 pandemic. this study will be included children with cystic fibrosis who had stabile conditions patients' peripheral muscle function, sleep quality and physical activity level will be assess and record at beginning, after the twelve and eighteen session.

Eligibility criteria:
inclusion criteria: * people who diagnosed cystic fibrosis disease at stabile conditions. * volunteering to participate in the study, * having a social isolation due to covid-19 pandemic * having forced expiratory volume at one second (fev1) %\> 40 % at last pulmonary function test. exclusion criteria: * being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month. * having a diagnosed with covid-19 before or during the study * being physically or perceptually competent to exercise * patients with allergic bronchopulmonary aspergillosis (abpa) who were treated with systemic steroid therapy * patients who were not complete the exercise training ability. * having fev1 %\< 40% at pulmonary function test.

Keywords: exercise sleep cystic fibrosis
effects of early and delayed time-restricted eating in adults with overweight and obesity

Conditions: Time Restricted Feeding; Intermittent Fasting; Obesity; Overweight and Obesity

Summary: time-restricted eating (tre) is a dietary approach that aims to increase fasting time and decrease the eating window. promising tre effects on weight loss and some cardiometabolic risk factors have been reported. however, there is a lack of randomized clinical trials that directly investigate the effect of tre at different times of the day (early vs. delayed) in individuals with overweight and obesity. the present study investigates the effects of 8 weeks of tre performed at different moments of the day on body composition and cardiometabolic parameters in adults with overweight and obesity.


Eligibility criteria:
inclusion criteria: * male and female; * body mass index (bmi) between 25 and 34.9 kg/m²; * age between 20 and 40 years; * not engaged in any structured exercise program; * weight stable for \~3 months prior to the beginning of the study; * able to give written informed consent. exclusion criteria: * current smoker; * cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc); * current treatment with medication or supplements which significantly affect the main studied variables; * night-shift workers; * night eating syndrome; * irregular sleep patterns; * for women: pregnancy, planned pregnancy (within the study period), lactating or menopause; * habitual fasting window \>16 hours; * concomitant participation in other studies.
a phase 3 study of vx-659 combination therapy in subjects with cystic fibrosis heterozygous for the f508del mutation and a minimal function mutation (f/mf)

Conditions: Cystic Fibrosis

Summary: this study will evaluate the efficacy of vx-659 in triple combination (tc) with tezacaftor (tez) and ivacaftor (iva) in subjects with cystic fibrosis (cf) who are heterozygous for f508del and a minimal function mutation (f/mf subjects).


Eligibility criteria:
key inclusion criteria: * heterozygous for f508del and an mf mutation (as defined in the protocol) * forced expiratory volume in 1 second (fev1) value ≥40% and ≤90% of predicted mean for age, sex, and height key exclusion criteria: * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply
the effect of radiation on semen quality and fertility in men with prostate cancer

Conditions: Prostate Cancer

Summary: many younger men are diagnosed with prostate cancer. these patients are often choosing radiation therapy as their primary treatment. the effect of this therapy on fertility will have a direct impact on their decision about therapeutic options and fertility preservation. the researchers hypothesize that when patients are treated with radiation for localized prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting sperm quality.

prostate cancer is the most common malignant disease among men. many young men are diagnosed with localized prostate cancer. some of these men are choosing to manage their prostate cancer with radiation therapy. the radiation therapy delivers minimal dose exposure to adjacent organs. we hypothesize that when patients are treated with radiation therapy for localized prostate cancer, decreased fertility can occur due to damage of seminiferous tubules, which may affect sperm quality. this study will assess the impact of radiation therapy on semen and seminal fluid.

Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed low risk to moderate stage prostate cancer (gleason 6 - 7) treated with brachytherapy or external beam radiation * \> 12 months ago exclusion criteria: * subjects with a prior history of infertility * subjects who have undergone vasectomy * subjects who have received lhrh therapy for prostate cancer \< 6 months ago * subjects who have received anti-androgens \< 3 months ago * subjects using alpha blockers within 7 days of specimen provision * subjects who have taken finasteride or dutasteride within the previous 4 months.

Keywords: prostate cancer brachytherapy radiation semen fertility
prevalence and environmental risk indicators for periodontitis. a cross-sectional study

Conditions: Periodontal Diseases; Periodontitis; Lifestyle; Mediterranean Diet

Summary: periodontitis is a biofilm-mediated chronic inflammatory disease with a multi-factorial etiology; it belongs to the group of diseases classified as "non-communicable diseases" (ncds). according to the results of the global burden of disease study of 2017, it is the sixth most prevalent disease worldwide and it constitutes a heavy burden on health costs. risk factors for such disease include non-modifiable risk factors, i.e. familiarity, diabetes, cardiovascular diseases, metabolic syndrome, as well as modifiable risk factors, i.e. diet, stress and low physical exercise. given the significant impact of oral health on the quality of life and overall well being of the individual, many studies investigated the importance of risk factors for oral health. in particular, there is some evidence that more severe manifestations of periodontitis are associated with lower physical activity (de oliveira ferreira et al., 2019), poor sleep quality (karaaslan \& dikilitaş, 2019) and more perceived stress (coelho et al., 2020). with regards to diet, despite the high number of studies demonstrating an anti-inflammatory effect of the mediterranean diet, no study has ever investigated the adherence to mediterranean dieta to the oral health status. from a methodological standpoint, investigations regarding environmental factors are mainly carried out through questionnaires administration, whose validity and reproducibility had been previously demonstrated. the novelty introduced by the present study would be a complete analysis of the effects of lifestyles (diet, sleep quality, physical exercise, perceived stress) on the periodontal status of the individual.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old; * ability and willingness to give informed consent. exclusion criteria: * pregnancy or lactation; * inability to communicate either in english or italian; * inability or unwillingness to give informed consent.
texting for relapse prevention

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to examine whether texting for relapse prevention (t4rp), a text messaging-based early warming for relapse prevention in people who have schizophrenia/sad, is associated with fewer relapse symptoms compared to a treatment-as-usual control group.

schizophrenia is among the 20 most debilitating illnesses worldwide, responsible for 1% of the global burden of disease. schizoaffective disorder (sad) affects an additional 0.2% to 1.1% of adults. as many as four out of five people who have schizophrenia or sad relapse within 5 years of recovery from their initial episode. interventions aimed at early intervention to prevent relapse would impact public health. the texting for relapse prevention (t4rp) is an innovative service delivery program delivered via text messaging designed for people who have schizophrenia/sad. the intervention will be tested in a randomized controlled trial against a treatment-as-usual control group which, for most, involved meeting with their therapist every 2 to 4 weeks and meeting with their psychiatrist at least once every 90 days or more frequently as clinically indicated. a total of 40 people with schizophrenia and 5-15 provider participants (depending on the patient distribution across the providers) in the pilot rtc. the study is being conducted by researchers at the center for innovative public health research and johns hopkins community psychiatry program (jhcpp). the investigators posit that t4rp will reduce psychiatric morbidity and institutionalization rates and promote recovery by facilitating improved patient-provider communication, promoting medication adherence, helping people self-monitor their early warning signs, and promoting self-management of symptoms. if t4rp is effective, this cost-effective and easily scalable intervention will make a significant public health impact and reduction in relapse-related costs for people with schizophrenia/sad.

Eligibility criteria:
inclusion criteria: * be english-speaking; * have a chart diagnosis of schizophrenia or sad * be able to provide consent (i.e., pass the capacity to consent screen) * own a cell phone and report using the text messaging function * be currently at their personal baseline with regard to symptoms and functioning as assessed by their provider (i.e., not in relapse and compliant with treatment) * be actively under the care of a mental health provider enrolled in the program * agree to continue attending the clinic for the duration of the study * plan to keep the same cell phone number for the duration of the study * have at least one of their providers consent to take part in the study exclusion criteria: * have at least one of their providers consent to take part in the study

Keywords: relapse prevention people with schizophrenia text-messaging assertive community treatment (act)
azithromycin treatment for respiratory syncytial virus-induced respiratory failure in children

Conditions: Respiratory Syncytial Virus Infections

Summary: the overarching hypothesis of the arrc trial is that administration of azithromycin (azm) during acute, respiratory syncytial virus (rsv)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (mmp)-9 pathway.

the proposed study will be a randomized, double-blinded, placebo-controlled phase iii trial to examine the efficacy of azm therapy relative to placebo in reducing rsv-related morbidity. patients will be recruited during acute hospitalization and admission to the icu at 10 pediatric hospitals. the target population selected is pediatric patients with severe rsv lung disease as defined by need for icu management and intensive respiratory support.

Eligibility criteria:
inclusion criteria: * admission to the pediatric icu with a confirmed diagnosis of rsv infection. rsv infection is based on a positive nasal swab for rsv fluorescent antibody or via multiplex assay or culture; * requiring intensive respiratory support defined as either mechanical ventilation or niv (bipap or cpap) or hfnc (at \>1 l/kg/min of flow * enrollment into the study within 48 hours of icu admission and placement on intensive respiratory support; * onset of rsv-related symptoms must be less than 5 days * age: neonates-2 years. for those less than 1 week of age, they must have been discharged home from the hospital after their birth. exclusion criteria: * azm use within 7 days of icu admission; * contraindication to azm use including known hypersensitivity to azm, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dl or alt ≥ 10 times the upper limits of normal); * patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram qt interval corrected for heart rate (qtc) ≥ 450 milisecond (ms); * intensive respiratory support greater than 48 hours prior to icu admission; * chronic ventilation or supplemental oxygen need at home; * immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids; * history of pyloric stenosis; * azm is deemed necessary for clinical treatment (for instance, if patient has pertussis).

Keywords: rsv azm icu respiratory support children
robot-assisted partial knee replacement versus standard total knee replacement

Conditions: Knee Osteoarthritis

Summary: this is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

knee osteoarthritis (oa) pain is an important source of morbidity and cost to the health care system. over 60,000 knee replacement surgeries are performed in canada every year, making it the second most common surgery. our institution (st. joseph's healthcare hamilton) is the first hospital in canada to purchase a mako rio orthopaedic robot to assist with performing knee replacements. the knee is divided into three compartments, and one, two, or all three compartments can become arthritic. over 90% of patients with end-stage knee oa receive a total knee replacement (also known as total knee arthroplasty or tka) even if they have one or two healthy knee compartments. partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. for this reason, few surgeons are experts at partial knee replacements. we believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. this may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for canadians. this will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.

Eligibility criteria:
inclusion criteria * adult (18+) * unicompartmental knee oa with or without concomitant patellofemoral oa, requiring surgical treatment * two study surgeons independently agree that the patient is eligible for either treatment group exclusion criteria * inability to provide informed consent (e.g. cognitive disability, language barrier) * revision knee surgery * simultaneous bilateral knee surgery * previous major knee surgery or trauma * the robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock) * a ct scan cannot be obtained prior to surgery * patient does not wish to participate

Keywords: total knee arthroplasty unicompartmental knee arthroplasty robot-assisted surgery pilot randomized controlled trial bicompartmental knee arthroplasty mako partial knee
home telemonitoring system for patients with heart failure vs usual care

Conditions: Heart Failure

Summary: this randomized controlled clinical trial compares a home telemonitoring system (hts) versus usual care during a 90 days follow-up period of heart failure (hf) ambulatory patients, in order to evaluate if the use of the hts improves quality of life and hf related-knowledge. the study was reviewed and approved by the methodological committee and by the research ethics committee from the provincial health system, according to the declaration of helsinki. written informed consent was obtained before randomization.


Eligibility criteria:
inclusion criteria: * were over 18 years with a primary diagnosis of hf, * had been hospitalized at least once time as a consequence of a hf decompensation, * had a smartphone, * had access to wifi, * had access to a weight scale and to a blood-pressure monitor exclusion criteria: * illiterate patients, * had learning difficulties, * had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.
effects of mhealth message on metabolic syndrome and bone loss of hiv infected persons in taiwan

Conditions: Hiv

Summary: with improved aids treatment leading to extended survival, hiv-infected individuals face a higher metabolic syndrome incidence. this study aims to determine the prevalence of non-aids related comorbidities (narc) in hiv-infected individuals. using purposive and snowball sampling, the cross-sectional survey targets 400 hiv-infected individuals aged 30 and above. data collection includes demographics, physical activity, nutrition, depression, and physiological measurements. analyzing the data through statistical tests and structural equation modeling, the study aims to provide precise care recommendations for preventive medicine and healthy aging in this population.

with the success of treatment, the survival period of acquired immunodeficiency syndrome (aids) patients is prolonged. compared with non-hiv-infected persons of the same age, hiv-infected persons have a relatively higher incidence of metabolic syndrome (ms). the main purpose of this study is to estimate the prevalence of common non-aids related comorbidities (narc) among hiv-infected persons this study is a cross-sectional survey, purposive and snowball sampling will be applied. the recruitment information is released through channels such as aids case managers, aids non-government organizations, and social networks of hiv-infected people all around taiwan. the expected sample size is 400 hiv-infected persons over the age of 30, after signing a written consent form, a test will be conducted, including the collection of demographic data, questionnaire data collection with physical activity scale, mini-nutrition assessment scale, and depression self-test scale, and measurement of physiological parameters using instruments including a gripper, body composition meter, sphygmomanometer, blood glucose, and lipid monitor, tape measure. the chi-square test and independent sample t-test are used to compare the differences in the categorical and continuous data of each variable, and the structural equation model is used to conduct path analysis of the research framework. the research results can be used as precise care recommendations for the development of preventive medicine and healthy aging for hiv-infected persons.

Eligibility criteria:
inclusion criteria: * hiv-infected persons over the age of 30 exclusion criteria: -

Keywords: hiv-infected persons metabolic syndrome
humax-cd20 in b-cell chronic lymphocytic leukemia (b-cll) patients failing fludarabine and alemtuzumab

Conditions: Leukaemia, Lymphocytic, Chronic

Summary: the purpose of this study is to determine whether humax-cd20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.


Eligibility criteria:
inclusion criteria: 1. tumor cell phenotype consistent with b-cll 2. patients with active b-cll and with an indication for treatment 3. failing at least one fludarabine-containing treatment regimen 4. failing at least one alemtuzumab-containing treatment regimen 5. ecog performance status of 0, 1, or 2 6. life expectancy of at least 4 months exclusion criteria: 1. previous treatment with alemtuzumab within 6 weeks prior to visit 2 2. previous autologous stem cell transplantation within 6 months prior to visit 2 3. allogeneic stem cell transplantation 4. radioimmunotherapy
effect of acute and sub-acute administration of gluten on extra-intestinal and gastrointestinal symptoms in patients with non-coeliac gluten sensitivity

Conditions: NCGS; Gluten

Summary: the investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in ncgs patients.


Eligibility criteria:
inclusion criteria: * non-coeliac gluten sensitivity patients * previous symptoms of ibs fulfilling rome iii criteria that self reportedly improved with a gluten-free diet * symptoms currently well controlled on a gluten-free diet * adherence to the gluten-free diet for at least 6 weeks prior to recruitment * coeliac disease excluded (either by absence of the hla-dq2 and hla-dq8 haplotype or by a normal duodenal biopsy (marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the hla-dq2 or hla-dq8 haplotype) * iga anti-tissue-transglutaminase or igg anti-deaminated gliadin peptide positive * body mass index (bmi) of 20 - 25 kg/m2 * stable body weight for at least 3 months prior to the start of the study exclusion criteria: * medical * coeliac disease * abdominal or thoracic surgery. exception: appendectomy * gastrointestinal, endocrine or neurological diseases * cardiovascular, respiratory, renal or urinary diseases * hypertension * food or drug allergies * psychiatric disorders * eating disorders * depressive disorders * anxiety disorders * psychotic disorders * restraint or emotional eating * medication on a regular basis, exception: oral contraception * history of cannabis use or any other drug of abuse for at least 12 months prior to the study * alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week) * pregnant or breastfeeding women
study of mobile phone delivered intervention to reduce alcohol consumption

Conditions: Alcohol Abuse

Summary: in this study, the investigators will be developing and testing a mobile phone text message intervention to reduce alcohol use for people at risk of alcohol dependence. the investigators hypothesize that this intervention will be acceptable to participants, and that they will stay in the intervention until it's one week completion.


Eligibility criteria:
inclusion criteria: * audit score 15-20 * have a mobile phone capable of receiving text messages exclusion criteria: * age \<18 * unable to consent * language other than english or spanish

Keywords: alcohol mhealth sbirt