Kornimate/medical-research-clean huggingface dataset:
does the access to small delicious dishes, have a positive effect on nutritional intake in patients at nutritional risk?

Conditions: Malnutrition

Summary: rationale: the objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. the investigators target was for 70% of patients to reach 75% of their energy and protein requirements. methods: an intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the nrs-2002 criteria. the food concept consisted of 36 small delicious dishes. patients could choose food from both the new concept and the ordinary patient buffet. the investigators monitored patients' nutritional requirements and daily nutritional intake.


Eligibility criteria:
inclusion criteria: * patients at nutritional risk, according to the nrs-2002 criteria. * patient must be able to understand the information and be able to give a written inform consent * well-functioning gastrointestinal tract * anticipated length of hospitalization \> 5 days * should understand and speak danish exclusion criteria: * terminal patients * patients with dysphagia * patient with food allergy or intolerance * patients who only receives enteral or parenteral nutrition

Keywords: nutrition new energy dense food concept
formal physical therapy (pt) vs. home pt for adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: this study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.

patients with adhesive capsulitis receive a glenohumeral and subacromial injection routinely for treatment. in addition, the patients are routinely prescribed physical therapy with a home exercise component. the purpose of this study is to evaluate whether home exercise alone is an alternative option to physical therapy. patients will be approached about the study after they have agreed to receive a glenohumeral and subacromial injection per standard of care for their clinical treatment. the hypothesis being tested is whether home exercise is alone is as beneficial for pain relief, restoration of range of motion, and improvement in shoulder disability from adhesive capsulitis as physical therapy. additionally sex differences, diabetes mellitus, endocrine, and mental health histories will be noted.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of adhesive capsulitis (limited range of motion) 2. given glenohumeral and subacromial injection as part of standard care. 3. capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient) 4. english speaking 5. 18 years of age or greater exclusion criteria: 1. prior glenohumeral or subacromial corticosteroid injection within 6 months 2. prior ipsilateral shoulder surgery 3. current prescription (narcotic) pain medication use 4. pain disorder (ex. fibromyalgia, reflex sympathetic dystrophy) 5. cervical radiculopathy 6. full-thickness rotator cuff tear 7. calcific tendinopathy (past or present) 8. advanced stage osteoarthritis as seen on radiograph 9. past/present ipsilateral shoulder fracture 10. women that may be pregnant or nursing (self report) past/present physical therapy treatment will be documented, but will not be considered an exclusion factor. the reasoning behind this is that the physical therapy likely was not properly targeting the adhesive capsulitis for the patient to arrive in an orthopaedic clinic and is likely at a similar starting point to most other patients regardless of previous physical therapy. all patients currently enrolled in physical therapy will be assigned to either our physical therapy or home exercise program.

Keywords: physical therapy home exercise adhesive capsulitis
genetic variants replication study associated with dependence on sulfonylurea in participants with type 2 diabetes

Conditions: Diabetes Mellitus

Summary: this study was designed to reproduce candidate single nucleotide variants found by whole exome sequencing in some type 2 diabetic patients dependent on sulfonylurea in a separate patient group. the validation of the dependence-related variations performed in this study is expected to help decision-making in the clinical use of sulfonylurea in the future.

sulfonylurea, one of the oral hypoglycemic agents, is the oldest and most widely used drug. the use of sulfonylurea was overwhelming compared to metformin especially in east asia, where insulin secretion was notable during the pathophysiology of type 2 diabetes. however, sulfonylurea causes hypoglycemia and weight gain, increases cardiovascular disease and mortality compared to other oral preparations. with the recent development of other oral hypoglycemic agents for lowering blood glucose without the risk of hypoglycemia and with cardiovascular protection, sulfonylurea is in a decreasing state of use worldwide. but some patients tend to be highly dependent on sulfonylurea for blood glucose control. it suggests that there will be a group of patients whose the action of sulfonylurea is strongly influenced by genetic factor, since insulin secretion of pancreatic beta cells is very hereditary, genetic variations that increase the risk of type 2 diabetes are found mainly in genes related to beta cell dysfunction rather than insulin resistance, and the more risk variants of type 2 diabetes, the less likely the effect of sulfonylurea is. the investigators had performed whole exome sequencing in patients showing dependence on sulfonylurea and identified tens of candidate variants. in this study, the investigators will select patients with dependence on sulfonylurea by prospective intervention (by discontinuing and resuming sulfonylurea) and perform genetic tests.

Eligibility criteria:
inclusion criteria: among patients with type 2 diabetes who visited seoul national university hospital endocrinology outpatient clinic, all of criteria (1)-(4) are satisfied 1. adults over 19 years 2. more than 10 years of diabetes 3. low dose sulfonylurea use: equivalent capacity 2 mg or less of glimepiride 4. less than 7.5% of glycated hemoglobin for more than 6 months 5. estimated glomerular filtration rate \> 50 ml/min/1.73㎡ exclusion criteria: * type 1 diabetics * insulin user * patients diagnosed with cardiovascular disease, cancer, and other critical illness within 6 months before the study * patients with severe hypertension * patients with treatment or diseases that may have a significant effect on blood glucose levels, such as glucocorticoids and thyrotoxicosis

Keywords: sulfonylurea
pulmonary rehabilitation in non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: the purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.

bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. the aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. in this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. volunteers will be randomly divided in pulmonary rehabilitation (prg) and control groups (cg) that will be subdivided in bronchiectasis and healthy subgroups. in the prg group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while cg will be informed about the benefits of physical activities. all volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants

Eligibility criteria:
inclusion criteria: * clinically stable patients * both sexes * aged between 18-60 years * not due to cystic fibrosis bronchiectasis diagnosis * non smokers * no pulmonary disease exclusion criteria: * asthma or other restrictive conditions * smokers assets * decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the protocol.

Keywords: bronchiectasis mucociliary clearance exercise inflammation
handwriting interventions for people with parkinson's

Conditions: Parkinson Disease

Summary: background: problems with handwriting are frustrating and debilitating and affect the majority of people with parkinson's. manifest as micrographia it is a distinctive feature of the condition characterised by small handwriting and/or a progressive reduction in size through a sentence\[2\] coupled with a reduction in writing speed and legibility. in parkinson's impaired automaticity is thought to contribute to handwriting deficits and attention has been shown to improve both 'consistent' (small handwriting) and 'progressive' (progressive reduction in letter size through a sentence) aspects of the symptom. moreover, recent interventional studies indicate handwriting may be improved through practice. this study is investigating a novel handwriting practice stimulus to improve symptoms of micrograpthia question: is a diverging line cued handwriting intervention potentially more effective at improving symptoms of mircograpthia than a parallel line cued handwriting intervention in people with parkinson's? specifically, an assessor blind randomised controlled exploratory trial will: 1. estatimate the effect of the intervention on measures of: handwriting amplitude (consistent and progressive reduction), hand writing performance and percieved handwriting difficulties. 2. explore the appropriateness of these outcome measures 3. explore the approriateness of eligibilty criteria 4. explore intervention fidelity 5. explore participants views of the intervention design: a phase ii exploratory randomised controlled trial of a handwriting intervention with an active comparator control group and blinded assessments setting: the intervention will be carried out at home sample size: this study is not designed to determine efficacy. the aim to recruit a total of 50 people (25 people per group) in order to estimate the effects on outcome measures and achieve the aims of this exploratory trial. assessment: participants will be asked to follow their usual parkinson's medication regime and if they have on and off periods, assessments will be carried out during on state. duration and follow-up: the assessment is schedule 0weeks (baseline), 6weeks (end intervention) and 12weeks (follow up). assessments will be carried out by a researcher blind to trial arm allocation using all outcome measures.


Eligibility criteria:
inclusion criteria: * over 18 years old * diagnosis of idiopathic parkinson's disease * a score of ≤3 on the hoehn and yahr scale * self-reported problem with handwriting (≥1 updrsii, 2.7) * able to communicate in italian * following a stable medication regimen (no changes in the last 2 weeks and anticipated changes for the course of the study). exclusion criteria: * severe depression or psychosis (history of), * reduced cognition that would preclude active involvement or capacity to consent (according to stages outlined in metal capacity act (ie trigger, information, existing diagnosis, functional test)) * orthopaedic, neurological or other condition that significantly impairs hand function, * pregnancy

Keywords: handwriting, micrographia
regulatory post-marketing surveillance study for brolucizumab

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study is an open-label, multicenter, single-arm, observational post-marketing surveillance.

the investigators will collect safety information and evaluate effectiveness in patients who are prescribed beovu ® injection, beovu ®prefilled syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. in addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years with namd that are prescribed with brolucizumab as per approved local product information 2. patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent) exclusion criteria: 1. contraindications as per local prescribing information 1) hypersensitivity to the active substance or to any of the excipients. 2) active or suspected ocular or periocular infection. 3) active intraocular inflammation. 2. patients participating in other investigational drug trial

Keywords: namd neovascularized age related macular degeneration beovu regulatory post marketing study beovu injection beovu prefilled syringe
real-world mapping antithrombotic regimens in mm patients on treatment

Conditions: Multiple Myeloma; Diagnosis

Summary: the goal of this observational study is to learn about antithrombotic regimens in multiple myeloma patients. the main question it aims to answer is the efficacy of different types of thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous thromboembolism (vte).

this is an observational prospective cohort study aimed at assessing the efficacy of different types of thromboprophylaxis in mm patients; the setting is the gimema network of the italian haematological centers. the observation time for each patient will be of 3 years from the start of the active treatment for mm. patients will remain in the study regardless of the stage of disease, type of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis, occurrence of thrombosis. four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis, cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.

Eligibility criteria:
inclusion criteria: 1. age equal to or greater than 18 years of age. 2. new diagnosis of symptomatic mm according to the crab or the slim criteria of the international myeloma working group 3. first active treatment for mm started after recruitment in the study 4. signed informed consent exclusion criteria: 1. patients having had thrombosis within 6 months before diagnosis of mm 2. patients with need of combined antithrombotic regimens (i.e. vka or doac or lmwk and one or two antiplatelet drugs) 3. ongoing first active treatment for mm initiated before the starting of the study.
a study to investigate the effects of gw856553 on patients with copd (chronic obstructive pulmonary disease)

Conditions: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to assess the safety of gw856553 in copd patients and to assess its affects on their copd disease after 14 days.


Eligibility criteria:
inclusion criteria: * women of childbearing potential * established history of copd * cigarette smoking history greater than 10 pack years * fev1 between 40 and 80% of predicted normal for height, age and sex. exclusion criteria: * morbidly obese patients (body mass index \>40) * hospitalisation or treatment for worsening of copd in past 6 weeks * history of increased liver function tests * hypersensitivity to salbutamol or ipratropium bromide * blood pressure \> 155/95

Keywords: pharmacodynamics pharmacokinetics tolerability copd safety
impact of integrating an addiction team on post liver transplantation survival for alcohol-related liver disease and its complications.

Conditions: Alcoholism; Alcohol Use Disorder; Alcohol; Liver

Summary: investigator seeks to determine wether integrating an addiction team into a liver transplantation unit improves the prognosis of patients with alcohol-related liver disease requiring liver transplantation. our hypothesis is that patients managed by an addiction team before and after liver transplantation have less frequent alcohol relapses, thus decreasing the risk of cardiovascular complications, de novo cancer, recurrence of alcohol-related cirrhosis, and consequently increasing their overall survival.

in this observational, retrospective and multicentre study, investigator seek to determine the effect of integrating an addiction team into liver transplantation unit on prognosis of patients with alcohol-related liver disease requiring liver transplantation. investigatore plan to compare patients in 2 groups, depending on whether they have received or not specific addiction care before and after transplantation. this study was conducted over a period of 15 years in three french liver transplant units.

Eligibility criteria:
inclusion criteria: * adult patients * who received a liver transplant between january 2000 and december 2015 for alcohol-related liver disease as a primary or secondary indication (hepatocellular carcinoma) * who survived for more than 6 months after their liver transplant. exclusion criteria: * association of other causes of hepatopathy: viral hepatitis b or c, hereditary hemochromatosis. * death before discharge from hospital after liver transplantation. * patient unwilling to participate to the study

Keywords: transplantation liver hepatocellular carcinoma alcohol
long-term follow-up protocol

Conditions: Dystrophic Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa; Dominant Dystrophic Epidermolysis Bullosa

Summary: the main objective of this prospective, observational, long-term follow-up (ltfu) study is to evaluate the long-term safety profile of the gene therapy products evaluated by krystal biotech, inc. which have a shared backbone of hsv-1, in participants who received at least one dose of investigational product (ip).

due to the guidelines for gene therapy for vectors which may undergo latency/ reactivation, krystal biotech, inc. has established a long-term follow-up protocol which will identify and mitigate the long-term risks to the participants receiving their gene therapy products and capture delayed adverse events in participants, annually, for 5-years following the last study visit. additionally, it will allow the sponsor to further understand the persistence of the gene therapy products used in their parent treatment protocols.

Eligibility criteria:
inclusion criteria: * all adult and pediatric participants who received at least one gene therapy treatment in a previous krystal biotech, inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the ltfu embedded into the parent protocol), as applicable. * consent/assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected. * participant is willing and able to adhere to the protocol requirements. exclusion criteria: * participants who enroll into a non-krystal biotech, inc. interventional gene therapy clinical trial will be excluded from the study.
sonett: switch study to once daily hiv treatment regimen with truvada

Conditions: HIV-1 Infection

Summary: there is an unmet medical need for potent art regimens that make adherence to treatment even easier due to qd dosing, offer a good tolerability profile and fit into the daily life of patients.


Eligibility criteria:
inclusion criteria: adult patients (over 18 years of age) of any ethnic group without restricted legal competence and who are capable of following the study instructions hiv-1 infection documented by confirmed positive hiv-1 antibody test and/or positive pcr for hiv-1 rna stable (no interruption or change of regimen in last 3 months) azt-and 3tc-containing regimen \> 3 months no documented prior virologic failure (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of hiv-rna \> 400 copies/ml while on art) cd4+ counts \> 50 cells/µl viral load \< 50 copies/ml karnofsky performance status ≥ 80% for women with childbearing potential, negative urine pregnancy test at screening visit exclusion criteria: serum phosphate level \< 0.65 mmol/l documented active opportunistic infections subjects with previously documented k65r, 69s mutations or 3 or more thymidine analogue mutations documented active malignant disease (excluding kaposi sarcoma limited to the skin) female of childbearing potential not willing to use a barrier method of contraception during heterosexual intercourse during the duration of study women who are pregnant or breast feeding known history of drug, medication or alcohol abuse within the last 12 months preceding the study simultaneous participation in another study with an investigational drug or within less than one month prior to this study inability or not willing to meet the requirements of the protocol history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication renal disease (creatinine clearance \< 50 ml/min according to cockroft_gault formula) or severe hepatic, respiratory or cardiovascular disease patients who have previously been enrolled into this study contraindication for one of the study substances.

Keywords: hiv-1 infection
placement of cs/lv pacing leads with ensite navx guidance

Conditions: Heart Failure

Summary: this study utilizes the 3d mapping capabilities of the ensite navx mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.


Eligibility criteria:
inclusion criteria: * patients schedule to undergo crt implant (per established guidelines) exclusion criteria: * standard exclusions to crt implant procedures