Kornimate/medical-research-clean huggingface dataset:
the use of social media platform to continuously support pregnant women with gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: to assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (gdm), compared to the control group under usual care. specifically, i. to measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform. ii. to measure the feasibility of using the social media platform to provide gdm support through participants' engagement levels and feedback questionnaire. iii. to measure the efficacy of using the social media platform to manage emotional responses in women with gdm. iv. to measure the efficacy of using the social media platform to optimize glycemic control in women with gdm.

engaging pregnant women with gdm in dietary management over the gestation has been challenging. this pilot trial aims to assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control among patients with gdm, compared to a control group receiving usual care. the study will employ a randomized controlled trial design, with gdm patients from kk women's and children's hospital (kkh) randomly assigned to either the usual care (control; n=40) or to additional support via a dedicated social media platform for a period of 1 month, where a moderator will be available to address patients' queries and share relevant educational resources (intervention; n=40). outcome measures include acceptance, satisfaction, and engagement levels, emotional well-being as well as the percentage achievement of time-in-range glucose readings for gdm patients. the independent t-test will be used to compare the outcome measures between groups. the findings from this study will provide valuable insights into the feasibility and efficacy of incorporating digital platforms into routine dietary counselling practices for improved patient outcomes and enhanced management of gdm.

Eligibility criteria:
inclusion criteria: * diagnosed with gdm as confirmed by the oral glucose tolerance test during pregnancy * age ≥ 21 and ≤ 45 years * attended first (baseline) session of gdm diet counselling session * able to read and comprehend english * have a digital device accessible to social media platform * have singpass access * able to provide informed consent exclusion criteria: * with known type 1 or type 2 diabetes * have multiple pregnancy

Keywords: maternal behaviour mobile health blood glucose emotional wellbeing engagement
lanreotide autogel in the symptomatic treatment of refractory diarrhea

Conditions: Diarrhea

Summary: the purpose of this study, is to assess the effect of lanreotide autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.


Eligibility criteria:
inclusion criteria: * male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator * patient mentally fit for completing a diary exclusion criteria: * has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea * had a weight of stool \< 600g in a 72hrs stool collection * has received a treatment with laxatives within the last week before study entry * suffers from ibs with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)

Keywords: symptomatic treatment of patients with refractory diarrhea
the effect of bepreve 1.5% on tear film osmolarity and tear film lipid layer

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to compare the effect of bepreve® with an artificial-tear eye drop on the quality of your tears.

this is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of bepreve compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis. subjects will be screened for this study on day one of dosing with the test article. subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. they will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either bepreve™ (bepotastine besilate ophthalmic solution) 1.5% or refresh tears® lubricant eye drops (1:1). subjects will instill one drop of test article either bepreve™ or refresh tears® into the study eyes twice daily for a maximum of 60 days. subjects will be seen for evaluation on days 0, 28±3, and 56±3 following randomization.

Eligibility criteria:
inclusion criteria: 1. are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis. 2. have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of visit 1. 3. agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study. 4. have a best corrected visual acuity of 20/200 or better in either eye. 5. are willing/able to follow instructions from the study investigator and his/her staff. 6. be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff. 7. are able to self-administer test article (or have a caregiver available to instill all doses of test article). 8. have signed informed consent approved by institutional review board or independent ethics committee. exclusion criteria: 1. have known hypersensitivity to either bepreve™ or refresh tears® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). 2. have active corneal pathology noted in the study eye at the screening visit. active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. 3. have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening. 4. have a history of abuse of alcohol/drugs within six months prior to the screening visit. 5. are pregnant or nursing/lactating. 6. have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Keywords: allergic conjunctivitis allergic conjunctivitis
effectiveness of oral anticoagulants in elderly patients with non-valvular atrial fibrillation and heart failure

Conditions: Atrial Fibrillation; Heart Failure

Summary: observational study of elderly individuals diagnosed with non-valvular atrial fibrillation and heart failure who are beginning oral blood thinners


Eligibility criteria:
inclusion criteria: * were age greater than or equal to 65 years as of the index date * had greater than or equal to 1 diagnosis of af prior to or on the index date * had greater than or equal to 1 diagnosis claim of hf during the 12 months prior to or on the index date * had 1 or more pharmacy claim for oral blood thinners exclusion criteria: * claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date * pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period * greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day * had medical claim indicating vte in the 12 months prior to index date other protocol defined inclusion/exclusion criteria could apply
efficacy of different behaviour change techniques in myplan 2.0

Conditions: Disease, Chronic

Summary: the aim of this study is to investigate the effectiveness of intervention 'myplan 2.0' and the efficacy of the different behaviour change techniques that are included. eight groups will be created that will receive a different version of the intervention, varying in three behaviour change techniques (action planning, coping planning, self-monitoring).

the effectiveness of the self-regulation-based e- and m-health intervention 'myplan 2.0' on changing physical activity and sedentary behaviour in the adult population will be investigated. furthermore, the role of three different behaviour change techniques (action planning, coping planning, self-monitoring) will be examined via a 2x2x2 design, in which 8 groups are created that all receive a different version of the intervention.

Eligibility criteria:
inclusion criteria: - 18 years old or older exclusion criteria: * not dutch-speaking * does not own a smartphone * does not have access to the internet * is not able to be physically active/non-sedentary

Keywords: physical activity sedentary behaviour ehealth mhealth self-regulation behaviour change techniques action planning coping planning self-monitoring prevention
clinical investigation of nms assist

Conditions: Parkinson

Summary: parkinson's can cause a wide range of non-motor symptoms (nms), including pain and problems with mental health, memory and sleep. these affect the quality of life of people with parkinson's (pwp) and their care partners (cp). if these issues are not recognised and managed quickly, they can result in escalating problems. many pwp are unsure of the extent and variety of the nms and how simple adjustments at home could improve them. we have developed a digital system, nms assist, to help pwp monitor their non-motor symptoms and develop skills to self-manage them. such a tool needs to be simple to use, safe and effective. we will ask 60 pwp, cp and members of their parkinson's healthcare team to use nms assist for 12 months, and we will monitor how they use the tool. pwp and cps will be asked if they feel more knowledgeable and confident to manage their own symptoms whilst being better able to discuss a problem with their healthcare professional. a smaller group of the participants will discuss their experiences in more detail to help pinpoint aspects that work well and those needing adjustment and development. members of the healthcare team will be asked to assess any improvement in communication with pwp and cps. it is thought that the use of this system will result in improved quality of life and increased knowledge and confidence for managing symptoms while safely reducing the time spent by health care professionals on manageable non-motor symptoms.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent and comply with intervention requirements * 18 years or older * be fluent in english * not resident in a care or nursing home * ambulant * have compatible smartphone/data access * normally under the care of the parkinson's service in the participating organisation * participant's hcp in the participating organisation consented to participate in the study exclusion criteria: * secondary cause of parkinsonism * significant cognitive impairment or a diagnosis of parkinson's disease dementia * living in residential care facilities * previous involvement in development or testing of the nms assist system * significant comorbidity, which in the opinion of the chief investigator would preclude safe participation in the study or protocol compliance (e.g. life expectancy \<6 months) * in a dependent/unequal relationship with anyone involved in the research or care teams

Keywords: parkinson disease self-management telemedicine
effect of medical treatment and prognosis of postural orthostatic tachycardia syndrome (pots)

Conditions: Postural Orthostatic Tachycardia Syndrome

Summary: the purpose of the study is to investigate effect of medical treatment and prognosis of postural orthostatic tachycardia syndrome (pots)

many patients who complained of dizziness are eventually diagnosed as pots. however, the investigation of an appropriate medical treatment of pots has not been enough yet. also, the prognosis of the disease after treatment is not well known. it is known that propranolol attenuate the tachycardia and improve symptom burden in patients with pots. however, the effect of other β-blocker, bisoprolol compared with propranolol is not known well. in addition, acetylcholinesterase inhibition with pyridostigmine was a effective method of acutely decreasing the tachycardia in patients with pots. however, difference among three medical treatments effect is not known and long-term studies are not done yet. therefore, in this study investigator investigate effect of medical treatment (propranolol only, bisoprolol only, propranolol+pyridostigmine, bisoprolol+pyridostigmine) and prognosis of postural orthostatic tachycardia syndrome. longer-term studies are needed to assess this promising therapy.

Eligibility criteria:
inclusion criteria: * aged 15\<= * developed symptoms of orthostatic intolerance accompanied by a hr rise ≥30 min-1 within the first 10 minutes of standing, hr rise ≥ 120 in the absence of orthostatic hypotension (a fall in blood pressure \[bp\] \>20/10 mm hg). exclusion criteria: * poor drug compliance * patients who cannot or do not want to write questionaires. * patients who do not want draw blood

Keywords: postural orthostatic tachycardia syndrome propranolol bisoprolol pyridostigmine
safety and efficacy study of high dose melphalan to treat multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma


Eligibility criteria:
inclusion criteria: * patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible. * multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of imwg2003/who2008 criteria. * patients with responsive disease after induction therapy not more than 6 courses of treatment * a complete response * a very good partial response * a partial response * at least 4 weeks long from last cytotoxic treatment(exclude bortezomib, thalidomide, dexamethasone); * eastern cooperative oncology group (ecog) scored 0 or 1 patient has an absolute neutrophil count of ≥1.5×109/l and platelet count≥80×109/l; * calculated creatinine clearance \>50ml/min by cockcroft-gault formula or collect urine within 24 hours. * patient with a total bilirubin ≤1.5 times of normal upper limit, ast,alt≤2.5times of normal upper limit; * cardio-pulmonary function is adequate to conduct autologous stem cell transplant. * ratio of body weight and ideal body weight \<175%; * all patients should have a life expectancy of more than 12 weeks * signed informed consent form voluntarily exclusion criteria: * cd34 positive hematopoietic stem cell collected \<2.0×106/kg * patients have a psychiatric history * female subject is pregnant or breast-feeding * patients are hypersensitive to this trial product or other alkylating agents * participate of other clinical trials within the past 4 weeks active cns lesions * concomitant of active infection or positive of hiv antibody * concomitant of other un-healed malignancy * left ventricular ejection fraction≤50% * patients with serious thrombosis * any severe concomitant disease that will expose study subjects to unacceptable risks. * patients not suitable to enroll by investigators considerations.
prospective exploratory study to describe hepatitis b virus (hbv) kinetics during treatment with telbivudine

Conditions: Hepatitis B, Chronic

Summary: this study will explore hbv kinetics in chb patients during the first 24 weeks of treatment with telbivudine


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age. * documented compensated hbeag negative chb defined by baseline hbv serology, dna and alt criteria. exclusion criteria: * co-infection with hcv, hdv, or hiv. * prior therapy with nucleos(t)ides in naïve patient and prior treatment with lamivudine in patients with suboptimal response to adefovir. * history of hepatic decompensation * history of malignancy * patient has one or more additional known primary or secondary causes of liver disease

Keywords: hepatitis b, chronic viral kinetics telbivudine adefovir compliance
effects whole body vibration in ergospirometrics parameters and quality of life

Conditions: Healthy

Summary: this study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. a case that is run like a vibration training combined, increasing strength and vo2.

the search use the spirometric values after whole body vibration training and resistance training

Eligibility criteria:
inclusion criteria: * aged 60 to 74 years * sedentary or irregularly active according to the ipaq short form with no known diseases exclusion criteria: * smoking * acute hernia * thrombosis * labyrinthitis * diabetes * hemodynamic instability * obesity * osteoporosis * neuromuscular diseases * pulmonary comorbidities * heart disease * electrocardiographic changes during exercise * taking medications that affected bone metabolism or muscle and don't adapt to any of the protocols

Keywords: whole body vibration aged vo2 muscle strength
a study to investigate the efficacy, safety and tolerability of nexagon® as a topical treatment for subjects with venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: this study is for subjects with a venous leg ulcer. the study is being done to determine if nexagon plus compression bandaging is more effective that placebo plus compression bandaging.


Eligibility criteria:
inclusion criteria: 1. diagnosis of venous leg ulceration supported by venous duplex ultrasonography demonstrating venous reflux \> 0.5 seconds 2. ankle brachial index of \> 0.80 3. venous leg ulcer (vlu) area greater than 2 cm2 and less than 20 cm2 4. compliant with and able to tolerate high compression bandaging 5. vlu present for \> 30 days prior to study entry 6. vlu is full thickness 7. the subject is willing and able to give informed consent exclusion criteria: 1. decrease or increase in the ulcer surface area by more than 40% during the 14 day run-in period 2. more than 75% of the vlu is on or below the malleolus 3. presence of a non-study ulcer within 1.5 cm of the vlu 4. a vlu which shows signs of clinical infection or has cellulitis 5. the vlu wound bed has exposed bone, tendon or fascia 6. bmi \> 45.0 kg/m2 7. subject is not ambulatory 8. subjects who have a past or present disease that, which as judged by the investigator, may affect the safety of the subject or the outcome of the study 9. cancerous cells in the vlu 10. hba1c \>10% 11. blood biochemistry \>3x upper limit of normal 12. heart failure nyha class iii or iv 13. subjects on renal replacement therapy 14. immunocompromized subjects

Keywords: vlu venous leg ulcers ulcers chronic wounds wounds nexagon coda
trial on the effect of budesonide/formoterol and inhaled budesonide alone on exercise-induced asthma

Conditions: Exercise Induced Asthma

Summary: the purpose of this study is to find out if symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. the investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

the purpose of this study is to find out if symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. the investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication. 40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

Eligibility criteria:
inclusion criteria: * male or female patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening * baseline fev1 of 60% to \>100% of predicted * demonstrate a decrease in fev1 of 15% or greater from baseline after standardized stepped exercise challenge testing * taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either: 1. fluticasone, 88 - 440 mcg/d via mdi or 100 to 500 mcg/d via dpi 2. beclomethasone hfa 80 to 480 mcg/day 3. budesonide dpi 180 to 1200 mcg/ d 4. flunisolide 500 to 2000 mcg/d 5. flunisolide hfa 320 to 640 mcg/d 6. mometasone 200 to 800 mcg/d 7. triamcinolone acetonide 300 to 1500 mcg/ d exclusion criteria: * patients already on labas, systemic corticosteroids, or other combination inhaled steroids/laba medications. * patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status. * patients who are pregnant or plan to become pregnant during the study period. * patients with a history of hypersensitivity reaction to either formoterol or budesonide. * patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. * patients with planned hospitalization during the study * current smokers or those with a history of 10 pack years of tobacco use or more.

Keywords: asthma exercise induced asthma
investigational covid-19 convalescent plasma infusion for severely or life-threateningly ill covid-19 patients

Conditions: COVID-19; SARS-CoV 2; SARS-CoV Infection

Summary: this is an expanded access program providing covid-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill covid-19.

this expanded access program provides hospitalized patients who are severely or life-threateningly ill with covid-19 access to investigational covid-19 convalescent plasma (ccp). a clinical team comprised of infectious disease specialists, pulmonary/critical care specialists and hospitalists identify appropriate patients in accordance with fda recommendations for patient eligibility and the daily availability of abo-compatible ccp. ccp is obtained through new york blood center and american red cross in coordination with the university hospital blood bank. safety outcomes include monitoring for transfusion-related acute lung injury (trali), transfusion-associated circulatory overload (taco) and any allergic reactions.patients admitted to our institution prior to the availability of ccp will be separately reviewed.

Eligibility criteria:
inclusion criteria: 1. laboratory confirmed covid-19. 2. severe or life-threatening covid-19. a) severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio \ 50% within 24 to 48 hours b) life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure exclusion criteria: 1. contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents 3. other documented uncontrolled infection 4. severe dic needing factor replacement, ffp, cryoprecipitate 5. acute renal failure requiring dialysis 6. active intracranial bleeding 7. clinically significant myocardial ischemia

Keywords: covid-19 convalescent plasma convalescent plasma transfusion