Kornimate/medical-research-clean huggingface dataset:
effectiveness of technology-supported hand strengthening and stretching exercises in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: growing research evidence supports the effectiveness of mhealth interventions for improving exercise adherence and motivation. the aims of our study are; 1) to develop and design a smartphone application for a structured hand exercise program for patients with ra and to test its usability. 2) evaluate the feasibility and effectiveness of hand exercise app. this study is a mixed-methods study that aims to investigate the effectiveness of the mar-handtherapy app: a qualitative and quantitative study with the iterative design approach.

the long-term beneficial effects of strengthening and stretching for rheumatoid arthritis (ra) for hand programs (sarah) on functions have been shown in recent studies. also, recently a usable web-based hand exercise program developed for patients with ra in uk. 1- the aim of our study is to develop and design a smartphone application for structured hand exercise program for patients with ra and to test its usability. 2- evaluate the feasibility and effectiveness of smartphone app hand exercise app. in our study, a qualitative iterative design approach that includes focus groups of experts/patients was used. the mobile application was designed in 3 phases: phase 1: we conducted focus group meetings to compromise the content, feature and design of app in the first phase (prototype version of smartphone software for ra hand training program/mar-hand-therapy app). focus group were consisted two physiotherapist (pt), three hand therapists (ht) working in the field in different rheumatology or hand rehabilitation clinics, two software-computer engineers, 3 patients with ra who had previously participated hand therapy. all focus group members (n=10) and 6 patients used the app for one week. all users filled the usability questionnaire, made the comments and advises. the revised version was tested again for one week. the last revised version completed after two weeks tested. 40 patients diagnosed with rheumatoid arthritis will be included to the study. participants randomized to digital intervention and waiting list control. after the 6-week digital intervention qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention. the primary outcomes are hand pain and function and exercise adherence.

Eligibility criteria:
inclusion criteria: * those diagnosed with rheumatoid arthritis according to ara criteria * ra patients with stage 2 or 3 according to acr criteria * the first symptoms started at least a year ago and those who are undergoing medical treatment * those between the ages of 18-65 exclusion criteria: * those who are in the inflammatory period * those who have had surgery for neurological, orthopedic or other reasons recently * those with specified depression or other psychological diagnosis * those who have received physiotherapy and ergotherapy in the past year

Keywords: mhealth hand exercise rheumatoid arthritis
safety study of a liposomal vaccine to treat malignant melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether lipovaxin-mm, a new anti-cancer vaccine, is safe and effective in improving the body's ability to destroy cancer cells in patients with metastatic melanoma.


Eligibility criteria:
key inclusion criteria: * patients with incurable stage iv malignant melanoma for which no standard or curative therapy exist or patients locoregionally recurrent melanoma (including local metastases, in transit metastases and satellitosis) where surgery is not the best therapeutic option. * must be able and willing to provide written informed consent. * eastern cooperative oncology group performance status of 0 or 1. * life expectancy of ≥12 weeks. * female subjects must be of non-child-bearing potential or using appropriate contraception. * positive test for cell mediated immunity. key exclusion criteria: * brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry and stable without steroid treatment for at least 4 weeks. * previous immunotherapy (except il-2 or interferon-based therapy) for melanoma. * inadequate bone marrow reserve. * serum bilirubin ≥1.2 times the upper limit of normal. * in absence of metastases, liver transaminase levels greater than 1.5 times the upper limit of normal. * if metastases are evident, liver transaminase levels 2.5 times the upper limit of normal will be acceptable. * inadequate renal function. * evidence of severe or uncontrolled systemic diseases. * unresolved toxicity ≥ctc grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the medical monitor. * participation in a trial of an investigational agent within the prior 30 days. * hiv infection. * immunosuppressive therapy including corticosteroids within 4 weeks of screening. * pregnant or breast-feeding females.

Keywords: melanoma cancer vaccines
da vinci transoral robotic-assisted surgery of pituitary gland

Conditions: Pituitary Neoplasms

Summary: over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. for many years, robotic-assisted surgery using the da vinci system (intuitive surgical inc, sunnyvale, california, usa) has been greatly developed, especially in urology and gynecology. robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective. a robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome. the investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (neurosurgical rev. 2014; 37:609-17). in this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da vinci robot in patients with pituitary adenoma.


Eligibility criteria:
inclusion criteria: * pituitary adenoma with a surgical indication : visual compression and chiasmal syndrome, intracranial hypertension , hormonal syndrome (hypopituitarism and hypersecretion ) , failure of medicamentous treatments for prolactinoma * no pituitary apoplexy (requiring emergency surgery) * spontaneous oral opening greater than 35 mm exclusion criteria: * insufficient buccal opening * intercurrent pathology of oropharyngeal and nasopharyngeal * complicated forms of adenoma pituitary adenoma (invasive adenoma) * hemostasis disorder * phlebitis or active pulmonary embolism
dose response relationship between fat ingestion and metabolism

Conditions: Glucose Tolerance Impaired

Summary: the goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. the main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in hunger. participant will consume four meals consisting of either 20, 40, 60, or 80% energy from fat.

the long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 30.0 kg/m2 * weight stable for the past 6 months (± 2kg) * vo2max values within a below average to above average range (38-50 ml/kg and 35-47 ml/kg for 18-25 year old males and females respectively. 35-48 ml/kg and 34-45 ml/kg for 26-35 year old males and females respectively) * fasting blood glucose \<6.0 mm * resting blood pressure \<140/90 mmhg * taking second generation oral contraceptives (females only) exclusion criteria: * smoking * diabetes, cancer, or other metabolic disorders * cardiac or gastrointestinal problems * infectious disease * barium swallow or nuclear medicine scan in the previous 3 weeks * follow a strict vegan diet * pregnant or breastfeeding (females only) * diagnosis of polycystic ovary syndrome (females only)

Keywords: high-fat glucose insulin metabolism nutrition
urdu version of functional gait assessment scale: reliability and validity study

Conditions: Stroke

Summary: the aim of study is to translate and culturally adapt functional gait assessment scale into urdu language and to investigate the reliability and validity in pakistani stroke patients. also check its correlation with berg balance scale and barthel index

the english version of the functional gait assessment scale will be translated and culturally adapted as per previous recommendation. in geriatric population, urdu version of functional gait assessment scale will distributed among 160 participants choose by convenience sampling technique based on pre-defined inclusion and exclusion criteria.to test inter and intra-observer reliability of the final urdu version of functional gait assessment scale, barthel index and berg balance scale, questionnaire will be filled on the same day. data will be entered and analyzed using statistical package of social sciences version 24. internal consistency will be analyzed with cronbach alpha value. test- retest reliability will be assessed for intra-class correlation coefficient. the urdu version of functional gait assessment scale was evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * age at least 18 years * post stroke patients past 3 months * both gender patients are included exclusion criteria: * patient suffering from any neurological disorder * patient suffering from any musculoskeletal disorder * patients who are post stroke less than 3 months

Keywords: functional gait assessment scale urdu version reliability validity stroke geriatric population
digital health weight management among public housing residents

Conditions: Weight Change, Body; Obesity

Summary: this research will test the efficacy of a weight management intervention through a three-group randomized trial: mhealth only, mhealth+community health worker (chw) support, versus control group, among residents of boston's public housing developments. the mhealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the chw support consists of monthly phone counseling delivered by a chw to support the text messaging program. our hypothesis is that the mhealth+chw group will be more effective in bringing about weight loss compared to mhealth alone or the assessment only control group. the findings are expected to inform future health promotion efforts among residents in public housing developments.


Eligibility criteria:
inclusion criteria: * current resident of boston public housing development * no plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year * able to read and speak in english or spanish * has cell phone with a plan that allows for unlimited text messages * willing to wear a device to track physical activity during assessment periods exclusion criteria: * currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation * currently on a medically prescribed diet or fast that is incompatible with study participation * currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition * precontemplation stage of change for making healthy eating or physical activity changes * pregnancy * medical contraindications to physical activity. self-reported presence of any of the following: * can not walk without help from someone else * regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen * gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath * advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse. * frequently gets pains in the heart or chest * had a heart attack in the past 6 months * often feels faint or has spells of severe dizziness * has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110 * has a good physical reason not to follow an activity program even if they wanted to

Keywords: community health workers public housing residents behavioral interventions healthy eating physical activity
explore potential plasma and balf immunometabolic and lipidomic biomarkers for identifying ards endotypes

Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Summary: acute respiratory distress syndrome (ards) is a life-threatening condition that causes high mortality (41% to 58%). previous studies have reported that biomarkers can facilitate phenotypic diagnosis of ards, enabling precision treatment of ards. although there were many studies that found some potential therapeutic targets for ards, no pharmacotherapies have been validated to treat ards. the development of biomarkers to predict the prognosis and monitor the response to treatment would be of interest for selecting patients for specific therapeutic trials. many recent studies have shown that immune metabolic changes are involved in the pathogenesis of ards and may become a new therapeutic target for them. we aimed to identify a panel of immunometabolic and lipidomic biomarkers derived from blood and bronchoalveolar lavage fluid (balf) which may help differentiate the ards endotypes.

protocol outline: this is an observational study. the blood and balf samples will be collected from patients with ards for exosome extraction and transcriptome and metabolomic analysis. exosome characterization and differential genes and metabolites will be identified.

Eligibility criteria:
inclusion criteria: 1. aged \>18 years old; 2. meet the diagnostic criteria of ards according to the berlin criteria. exclusion criteria: 1. aged≤18 years old; 2. pregnancy; 3. no informed consent;

Keywords: ards, biomarkers, immunometabolism
12-week polysomnography study of ropinirole controlled release for restless legs syndrome

Conditions: Restless Legs Syndrome (RLS); Restless Legs Syndrome

Summary: the purpose of this study is to assess the efficacy and safety of ropinirole cr-rls in the treatment of patients with restless legs syndrome and associated sleep disturbance and period limb movements during sleep.


Eligibility criteria:
inclusion criteria: * provided written informed consent. * diagnosed with primary rls using the international rls study group diagnostic criteria with a total score of 20 or greater on the international rls (irls) rating scale and significant sleep disturbance indicated on item 4 of the irls rating scale. * have evening and nighttime symptoms of rls, significant sleep impairment due to rls symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00pm. * sleep efficiency \ 20 minutes. exclusion criteria: * secondary rls * primary sleep disorder * have any medical conditions that may impact efficacy assessments or that may present a safety concern. * pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control. * use of any prohibited medication.

Keywords: restless legs syndrome ropinirole polysomnography rls psg
about oral and gut microbiota in intensive care unit : sars-cov-2 (covid-19) infection impact.

Conditions: SARS-CoV-2 Acute Respiratory Disease

Summary: the objective of the present study is to describe the negative impact on oral and gut microbiota of a severe acute respiratory syndrome sars-cov-2 infection in patients hospitalized in intensive care units (icu). the study would like to compare their microbiota to the microbiota of icu patients, non-infected by the sars-cov-2.

gut microbiota in icu patients is sorely distorted, there is an important loss of diversity which can be traduced by a decrease of commensal bacteria and an increase of pathogens. the virulence, infectivity, and transmissibility of the emerging sars-coronavirus 2 is a reason for us to find strategies and therapeutics to curb the epidemic. gut mucosa is very probably a target for the virus and it seems likely that feces are a way of transmissibility. it suppose too that gut microbiota is more weathered in patients with a sars-cov-2 infection, moreover if they have to be hospitalized in icu. for this reason, the present study would like to collect oral and rectal swab from patients hospitalized in icu for a serious sars-cov-2 infection and from patients hospitalized in icu for another reason that a sars-cov-2 infection at day 1, each 7 days and at the end of their icu stay. other objectives are to know if this distorted microbiota is a risk factor for poor outcomes in our icu patients, if antibiotics and artificial nutrition are too a risk factor of weathered microbiota and finally if we can connect oral and rectal dysbiosis to use the oral dysbiosis to predict the rectal dysbiosis in view of the ease to collect oral sample.

Eligibility criteria:
inclusion criteria: controls: - hospitalized patient with non-sars-cov-2 hypoxemic pneumonia patients covid 19: - patient hospitalized for sars-cov-2 hypoxemic pneumonia all: * patient hospitalized for less than 48 hours in a general intensive care unit * patient who has given free, informed and express (oral) consent to participate in the research (or a close relative or trusted person of the patient if the patient cannot express himself/herself) * patient covered by a social security system or equivalent * expected hospitalization of more than 48 hours exclusion criteria: * gut inflammatory disease * recent gut surger * ostomy * recent antibiotics * artificial nutrition in the long term

Keywords: sars-cov-2 covid 19 critical care microbiota microbiome
investigate effect of amg 151 on 24-hour ambulatory blood pressure & glucose levels in type 2 diabetes mellitus subjects

Conditions: Diabetes Mellitus

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of amg 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (dpp4), metformin and a thiazolidinedione (tzd), or metformin, a dpp4, and a tzd for a minimum of 3 months prior to randomization.


Eligibility criteria:
inclusion criteria * subjects with type 2 diabetes mellitus * on a stable regimen of metformin alone, metformin and a dpp4, metformin and a tzd, or metformin, a dpp4, and a tzd for a minimum of 3 months prior to randomization * body mass indices \> 25 and \< 45 kg/m2 * hemoglobin a1c levels ≥ 7.0% and ≤ 11.0% at screening * fasting c-peptide levels ≥ 0.2 nmol/l at screening * subject with a history of hypertension must be on a stable antihypertensive treatment (s) (type of medication, dose, and regimen) for at least 6 weeks prior to the first dose of investigational product * other criteria may apply exclusion criteria * subject has type 1 diabetes mellitus or history of type 1 diabetes mellitus * subject has had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening * poorly controlled hypertension defined as diastolic pressure ≥ 95 mmhg or systolic ≥ 155 mmhg (confirmed by a repeat assessment) at screening * triglycerides ≥ 400 mg/dl (4.52 mmol/l) at screening * use of any known cytochrome p450 (cyp) inducers within 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of investigational product. * use of any known inhibitors of cyp3a4/p-glycoprotein within the 14 days or 5 half lives (whichever is longer) prior to receiving the first dose of investigational product * other criteria may apply

Keywords: ambulatory blood pressure type 2 diabetes
risk model of cognitive impairment in diabetes

Conditions: Type 2 Diabetes Mellitus; Mild Cognitive Impairment

Summary: development and validation of a risk model for predicting the risk of mild cognitive impairment among individuals of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus ; * aged:40 -80 years ; * montreal cognitive assessment scale (moca) scores 19 - 30; exclusion criteria: * mini-mental state examination(mmse) scores \< 24; * other dementia related neurological diseases or depression, schizophrenia in the past 2 years; * central nervous system diseases, including brain trauma, intracranial hemorrhage, acute cerebral infarction; * severe sinusitis, nasal cavity and sinus polyps, skull base or nasopharyngeal tumors and other space occupying lesions, congenital diseases and traumatic history of nose, maxillofacial and skull base affecting olfaction; * diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or severe hypoglycemic coma.

Keywords: cognitive assessments olfactory test risk model
comparison of atrophogenic effect of hydrocortison 1% cream and pimecrolimus 1% cream assessed by optical coherence tomography (oct) and 20-mhz ultrasound of uninvolved skin in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to explore the atrophogenic potentials of hydrocortison 1% cream and pimecrolimus 1% cream on unaffected forehead skin


Eligibility criteria:
inclusion criteria: * age 18-60 years * diagnosis of atopic dermatitis (hanifin \& rajka criteria) * patients with atopic dermatitis not affecting the forehead exclusion criteria: * pregnancy / nursing mothers * women in reproductive age without adequate contraception * severe atopic dermatitis (iga \>= 4) * uv-therapy in past 4 weeks * patients receiving any topical treatment on the face in past 6 month

Keywords: atopic dermatitis pimecrolimus hydrocortison optical coherence tomography