Kornimate/medical-research-clean huggingface dataset:
arm use with soft-robotic glove

Conditions: Trauma Injury of Hand Multiple; Neurologic Disorder

Summary: this study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. for several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). the present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (carbonhand; bioservo technolo-gies ab, kista, sweden) on hand function, in order to better understand and explain the observed therapeutic effect.


Eligibility criteria:
inclusion criteria: * age between 18 and 90 years * experience difficulties in performing adl due to hand function limitations as a result of trauma-related injury or neurologic disorder * being in a chronic/stable phase of disease as judged by their physician * able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object * ability to relax an active grip * sufficient cognitive status to understand two-step instructions * having (corrected to) normal vision * able to provide written informed consent * living independently exclusion criteria: * severe sensory problems of the most-affected hand * severe acute pain of the most-affected hand * wounds on the hands that can provide a problem when using the glove * severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably * co-morbidities limiting functional use/performance of the arms and/or hands * severe spasticity of the hand (≥2 points on ashworth scale) * severe proximal weakness (mrc shoulder elevation\<4) * used the carbonhand system in the past 3 months * participation in other studies that can affect functional performance of the arm/hand * receiving arm-/hand function therapy during the course of the study * insufficient digital literacy to conduct video calls * insufficient knowledge of the dutch or english language to understand the purpose or methods of the study
routine evaluation of the social determinants of health in oncology: user-centered resource coordination and engagement

Conditions: Breast Cancer; Lung Cancer; Gastrointestinal Cancer

Summary: the purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.

this research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at dana-farber cancer institute. * the research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching. * participants will be randomized into one of two groups. * usual care or usual care with customized resource matching. it is expected that about 125 participants will take part in this research study.

Eligibility criteria:
inclusion criteria: * eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in dfci boc, top or gcc. to select for patients from demographic groups vulnerable to sdoh needs, two different groups will be eligible to participate. * group a * bipoc (black, latinx, native american or pacific islander) * lep spanish-speaking (as indicated by the ehr) * low ses (from zip code with median household income \<$32,000/year) or * age 70+ * group b * any one npiq response indicating sdoh need * health literacy/numeracy, caregiving/relationships, or finances exclusion criteria: - group a and b -- patients not continuing care at dana farber cancer institute

Keywords: breast cancer lung cancer gastrointestinal cancer
prevalence and risk factors for venous thromboembolic events in critically ill patients with covid-19

Conditions: SARS Virus

Summary: the purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new coronavirus disease, who are admitted to the intensive care unit for impending respiratory failure requiring intubation and mechanical ventilation. furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum. about 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization. critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects. acute respiratory distress syndrome represents the most common complication in patients with severe disease. several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population. the purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with sars-cov-2 admitted to the intensive care unit requiring invasive mechanical ventilation using vein ultrasonography.

Eligibility criteria:
inclusion criteria: * patients admitted to the intensive care unit * laboratory confirmed sars-cov-2 infection * invasive respiratory support exclusion criteria: * none
metabolic syndrome and fingertip endothelial dysfunction

Conditions: Metabolic Syndrome

Summary: life-style intervention with dietetic and exercise therapy is an important fundamental approach to patients with metabolic syndrome (metsyd) which may cause endothelial dysfunction leading to cardiovascular events. we investigated whether the life-style modification by dietetic and exercise instruction could improve endothelial dysfunction assessed by a new non-invasive and automatic device; digital reactive hyperemia peripheral arterial tonometry (rh-pat).

outline of methods rh-pat was measured in high-risk patients under 70 years old. the metsyd was defined according to guidelines of the national cholesterol education program third adult treatment panel (ncep - atp iii). we instructed all metsyd patients about the dietetic and exercise therapy according to the japan atherosclerosis society guidelines for prevention of atherosclerotic cardiovascular diseases. we conducted a questionnaire survey of the self-assessment for dietetic and exercise instruction program, respectively.

Eligibility criteria:
inclusion criteria: * under 70 years old and preserved left ventricular systolic function (left ventricular ejection fraction ≥ 50%) exclusion criteria: * severe valvular heart disease * atrial septal defect * myocarditis * cardiomyopathy * active inflammatory diseases * pulmonary hypertension * chronic kidney disease on hemodialysis * advanced hepatic disease * leukemia * schizophrenia; and * cerebrovascular disease and residual hemiplegia.
investigation into the automated drainage of recurrent effusions from the pleural space in thoracic malignancy.

Conditions: Pleural Effusion

Summary: this is a research study examining the safety of a new, automated pump for the drainage of fluid in the chest cavity which is caused by cancer (also known as malignant pleural effusion, or mpe). the purpose of the trial is to assess whether the new pleurapump device is safe and effective in the management of patients with mpe. the study will try to identify what kind of problems may arise from using the device, how often they happen, and how severe they are if they occur.


Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. recurrent pleural effusion due malignancy malignant pleural effusions are defined as either fluid in the context of histocytologically confirmed pleural malignancy, or pleural fluid in the context of histocytologically confirmed malignancy elsewhere, with no other clear cause for the effusion. 3. 1 or more therapeutic procedures for pleural fluid drainage prior to enrolment. 4. written informed consent 5. ability to comply with study procedures and ability to operate the device 6. expected survival of more than 3 months after device insertion exclusion criteria: 1. haemothorax 2. purulent pleural effusion 3. significant pleural fluid septation or loculation on thoracic ultrasound or cross-sectional imaging 4. obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device. 5. pregnant females or females anticipating pregnancy during study period. 6. patients currently enrolled in another interventional clinical study 7. concurrently implanted with any other active implantable medical device, including, but not limited to cardiac pacemaker or cardioverter defibrillator. 8. major comorbidity which, in the opinion of the principal investigator, is likely to significantly decrease life expectancy, increase anaesthetic risk, or lead to device removal (e.g. moderate to severe congestive heart failure, significant valvular heart disease, persistent immunosuppression, etc.) 9. other contraindication to general anaesthesia 10. other contraindication to procedure (e.g. uncorrectable bleeding diathesis, infection or malignant involvement over proposed insertion site) 11. significant renal impairment, as determined by the principal investigator
onset motor complications using requip cr (ropinirole controlled-release) as add-on therapy to l-dopa in parkinson's

Conditions: Parkinson's Disease; Parkinson Disease; Dyskinesias

Summary: this study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with parkinson's disease who have been taking levodopa for less than 2 years.


Eligibility criteria:
inclusion criteria: * must be on 600mg or less of levodopa therapy for two years or less. * must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening. exclusion criteria: * current or past history of dyskinesia. * state of dementia or have a mmse score \< 26 at screening.

Keywords: dyskinesia sinemet parkinson's disease controlled release ropinirole
feasibility study of normobaric oxygen delivered by a high flow concentrator in the treatment of chronic headache

Conditions: Chronic Headache

Summary: chronic headache is most often associated with drug abuse and medication overuse headache (moh) is the main complication of migraine disease results in chronic daily headache. the first phase of treatment consists of drug withdrawal . the second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use. the aim of this study is 1. verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (not) delivery by high flow concentrator 2. use normobaric oxygen therapy (not) as a therapeutic measure to treat headache through withdrawal period. it is a feasibility pilot study in chronic headache with or without medication-overuse. all patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". the subsequent attacks will be treated with not from a high-flow concentrator primary endpoint. feasibility study of treatment with not evaluated by the percentage of patients who accepted not during the withdrawal phase then to treat attacks. secondary endpoints. efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake). visits v1 (first visit) inclusion v2 at one month v3 at 3 months v4 (last vist) at 6 months effective : 30 patients


Eligibility criteria:
inclusion criteria: * migrainous according to the criteria of the international headache society * medication-overuse headaches according of the international headache society * no prophylaxis treatment or same prophylaxis treatment from more than one month * signed informed consent exclusion criteria: * pregnancy * one or more failed withdrawal treatment * analgesic treatment for another reason than headache * contraindication of normobaric oxygen therapy * contraindication of ketoprofen (rescue therapy)

Keywords: withdrawal therapy oxygen therapy
incidence of acute kidney injury and mortality in critically ill patients: urinary chloride as a prognostic marker

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) is characterized by a rapid decrease in renal function. it is frequent in hospitalized patients and its incidence is higher in critically ill patients. it is associated with high rates of morbidity and mortality. aki affects over 13 million people per year globally, and results in 1.7 million deaths. it is diagnosed in up to 20% of hospitalized patients and in 30- 60% of critically ill patients. it is the most frequent cause of organ dysfunction in intensive care units and the occurrence of even mild aki is associated with a 50% higher risk of death. aki has been associated with longer hospital stays, in-hospital mortality, cardiovascular events, progression to chronic kidney disease and long-term mortality. it results in a significant burden for the society in terms of health resource use during the acute phase and the potential long-term sequelae including development of chronic kidney disease and kidney failure. yunos et al. have focused on chloride, which is the most abundant strong anion in extracellular fluid. progression of hyperchloremia in the icu was identified as a predictor of increased mortality in a large retrospective cohort study of critically ill septic patients. sadan et al. have shown associations between hyperchloremia and an increased incidence of aki in patients with subarachnoid hemorrhage, as well as in patients who have undergone abdominal surgery. abnormal blood chloride concentrations were associated with metabolic acidosis, which may worsen patient outcomes. moreover, hyperchloremia may be caused by inappropriate fluid management with chloride-rich solutions. importantly, chloride-rich solutions were reportedly associated with hyperchloremia and major adverse kidney disease, including death, in intensive care settings. urine samples are relatively easy to collect in icu, and real-time urinary electrolyte monitoring device is available for clinical use. in addition, recent development of urinary aki biomarkers has enabled clinical evaluation of kidney function. komaru et al. examined associations among urinary chloride, mortality, and aki incidence in icu patients and concluded that lower urinary chloride concentration was associated with increased mortality and incidence of aki in the icu.


Eligibility criteria:
inclusion criteria: * age from 21 years old and above. * no history of chronic kidney disease (ckd). exclusion criteria: * age under 21 years old. * patients leaving the icu within 24 hours for any reason. * anuric patients. * patients on maintenance hemodialysis. * patients those without day 1 urinary or blood tests. * refusal of patient or his/her relative participation in the study
closed-loop glucagon administration for hypoglycemia treatment

Conditions: Type 1 Diabetes

Summary: this study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes \> 21 years old.


Eligibility criteria:
inclusion criteria: * age 21 years or older with type 1 diabetes for at least one year. * otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled). * self-reported frequency of documented hypoglycemia (bg \< 60 mg/dl) of at least 2 times per week * partial hypoglycemic unawareness (inconsistent symptoms with bg \< 50 mg/dl) or hypoglycemic unawareness (minimal or no symptoms with bg \< 50 mg/dl) exclusion criteria: * unable to provide informed consent. * unable to comply with study procedures. * current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. * pregnancy (positive urine hcg), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception * history of cystic fibrosis, pancreatitis, or other pancreatic disease other than type 1 diabetes * end stage renal disease on dialysis (hemodialysis or peritoneal dialysis). * any known liver or biliary disease including cirrhosis, alcoholic liver disease, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, any form of viral hepatitis. * congestive heart failure (established history of chf, paroxysmal nocturnal dyspnea, or orthopnea). * acute illness or exacerbation of chronic illness at the time of the study. * seizure disorder or history of hypoglycemic seizure in the last 1 year * history of pheochromocytoma. fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor: * untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year). * current alcohol abuse (intake averaging \> 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription). * electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to rf interference. * history of adverse reaction to glucagon (including allergy) besides nausea and vomiting. * unwilling or unable to completely avoid acetaminophen during the study period. * any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.

Keywords: bionic pancreas artificial pancreas insulin glucagon continuous glucose monitoring (cgm) outpatient insulin pump glucagon pump
trial comparing radioactive seed localization to standard procedure for non-palpable breast cancers

Conditions: Breast Cancer Invasive Nos; Stage 0 Breast Carcinoma

Summary: the purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).

most breast cancers are removed by partial mastectomy/lumpectomy. the most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. if the margin is positive, or the cancer recurs, more surgery or mastectomy is required. approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. accordingly, a localization technique is required to help the surgeon to find and remove the cancer. the current technique (needle localization) has a higher chance of having cancer cells at the margin. this is a study about a surgical technique. the objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. the main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. an improved technique would benefit thousands of women every year.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive or in situ breast carcinoma * nonpalpable breast tumour * candidate for breast conserving surgery (bcs) based on clinical and radiologic evaluation exclusion criteria: * histological confirmation more than 3 months from enrollment * pregnancy or lactation * contraindication to bcs or patient requests mastectomy * age less than 18 years * male patient

Keywords: invasive breast cancer in situ breast cancer radioguided seed localization nonpalpable tumour needle localization margin status
reactogenicity and safety of glaxosmithkline (gsk) biologicals' rotarix™ (human rotavirus vaccine) in indian infants

Conditions: Infections, Rotavirus

Summary: this post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the prescribing information in india.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this pms. * a male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * acute disease at the time of enrolment. * any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception. * known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine. * gastroenteritis within 7 days preceding vaccination.

Keywords: gastroenteritis