Kornimate/medical-research-clean huggingface dataset:
mhealth intervention to support diabetes medication adherence

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims at evaluating the effectiveness of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

a list of patients registered in primary care centers of the balearic islands and potentially meeting the eligibility criteria will be obtained from electronic health records (ehrs). a research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. all eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. participants will be randomly allocated using a computer-generated randomization sequence. all participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. in addition, the intervention group will receive the text messaging intervention. control participants will receive usual care only. after twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. data on glycemic control (hba1c) at baseline and post-intervention will be extracted from ehrs, as according to the protocol used for primary care providers in the balearic islands, patients with poor glycemic control (hba1c \>8% ) must request an hba1c determination every six months. results of the most recent determination will be extracted from electronic medical records. for those patients with no recorded hba1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.

Eligibility criteria:
inclusion criteria: * patients registered in the public health service of the balearic islands * with type 2 diabetes * at least one prescription of a glucose-lowering drug * with results of hba1c\>8% from 6 months prior to recruitment exclusion criteria: * younger than 18 years old * with insulin treatment * participating in another research study * not living in the balearic islands at some point during the study development

Keywords: diabetes medication adherence glycaemic control healthy lifestyle mhealth sms
efficacy and safety of valsartan/amlodipine in patients with mild to moderate essential hypertension

Conditions: Essential Hypertension

Summary: this study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (msdbp ≥90 mmhg and \<110 mmhg) on valsartan 160 mg alone.


Eligibility criteria:
inclusion criteria: * patients must give written informed consent * male or female ages 18 or older and less than 86 years * diagnosed as having essential diastolic hypertension, as follows: * visit 2/single-blind run-in entry, all participants must have a msdbp ≥ 95 mmhg and \< 100 mmhg * at visit 3/core double-blind treatment period entry, all patients must have a msdbp \>=90 mmhg and \<110 mmhg exclusion criteria: * severe hypertension * evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, pheochromocytoma or polycystic kidney disease ) * malignant hypertension * administration of any agent indicated for the treatment of hypertension after visit 1 * known moderate or malignant retinopathy. * known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin ii receptor blockers (arbs), calcium channel blockers (ccbs), or to drugs with similar chemical structures * history of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina * history of heart failure grade ii-iv according to new york heart association (nyha) classification * second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia other protocol-defined inclusion/exclusion criteria may apply

Keywords: blood pressure hypertension exforge valsartan/amlodipine
effects of colour-by-number mandalas ın children hospitalised due to a chronic disease

Conditions: Child, Only; Chronic Diseases in Children

Summary: purpose: this study was conducted to find out the effects of colour by number mandala in decreasing the stress of hospitalized children with chronic disease. design: a randomized controlled study. methods: this study was conducted with 120 children between the ages of 8 and 11. 60 children formed the experimental group, while 60 children formed the control group. descriptive information form and perceived stress scale were used in data collection.

experimental group: the children, along with their parents, were interviewed by one of the researchers on their first day of hospitalisation. the parents were informed about the descriptive information form and the perceived stress scale for children, which the researcher filled out in the presence of the children and their parents. the children were then given a colour-by-number mandala and colouring pencils. a different colour-by-number mandala was given to each participant every day; the mean length of hospital stay was 3 days. at the end of the third day, the same researcher interviewed the children and filled out again the perceived stress scale for children.

Eligibility criteria:
inclusion criteria: * parents who agreed to participate in the study exclusion criteria: * visually impaired child * mentally retarded child * speech impaired children
safety and efficacy study of the thoracic aortic stent graft system treating aortic dissection

Conditions: Aortic Dissection

Summary: this is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.

this trail is conducted in several centers all around china. in about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (zylox-tonbridge medical technology co., ltd. ). the subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years; * subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent； * subjects who are diagnosed with stanford type b aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery; * appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy. exclusion criteria: * the same surgery requires intervention for other vascular lesions； * history of surgery in the aortic arch or endovascular repair surgery; * severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent; * subjects with severe liver, kidney failure； * subjects with severe coagulation disorders； * female subjects who are pregnant, lactating within the study period or unable to contraception during the trail. * history of allergies to anesthetics, contrast agents or the material of stent/ deliver system； * inability to tolerate anesthesia； * history of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery; * subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint. * subjects with acute systemic infection * other circumstances judged by researchers that are not suitable for enrollment .

Keywords: aortic dissection thoracic aortic stent graft
study to evaluate trv120027 on renal pharmacodynamics in patients with heart failure and renal dysfunction

Conditions: Heart Failure; Kidney Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of trv120027 in subjects with heart failure and mild to moderate renal dysfunction.


Eligibility criteria:
inclusion criteria: * written informed consent * heart failure * mild to moderate renal dysfunction * age 18- \<75 * males and females (non-childbearing potential) exclusion criteria: * any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the investigator based on medical history, physical examination or laboratory tests * any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the investigator * allergy or clinically-significant intolerance to arbs or ace inhibitors * clinical signs or symptoms of acute decompensated heart failure * pregnant or lactating
auriculotherapy as a coping strategy in professional nursing

Conditions: Stress, Psychological; Coping Behavior

Summary: this randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a university hospital.

there is consensus that psychological and social factors can lead to physical health problems of individuals and coping strategies in stressful situations may be crucial for the mental, physical and social development of people. taking care of professionals who provide health services is a key strategy, since good results depend on the service, especially in work teams healthy and, therefore, able to promote the humanization of service.

Eligibility criteria:
inclusion criteria: * average and high score by the list of stress symptoms * voluntary participation in the study * availability of time for submission to the sessions exclusion criteria: * pregnancy * medical license or vacation during the period * low score of stress

Keywords: stress psychological coping behavior
comparison of cosmetic and functional outcome of silicone sheeting and micro-needling on hypertrophic scars

Conditions: Hypertrophic Scar

Summary: hypertrophic scars and keloids are frequently encountered in plastic surgery opd. due to any reason, the normal wound healing is impaired, hypertrophic scars or keloids occur. these are thickened, wide and raised scars. many treatment options are presented over time, but most of the treatments remain insufficient. treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. in this study outcomes of treatment with silicone sheeting and microneedling will be compaired.

hypertrophic scars and keloids are one of difficult conditions to treat. prevention of abnormal scaring is more effective than treatment, so avoiding unnecessary wounds in patients is a solution but flawed one. many treatment options are presented over time, but most of the treatments remain insufficient. treatment options include massage therapy, silicone sheet, occlusive dressings, pressure garments, adhesive tape, intra-lesional steroid injections, laser therapy, cryotherapy, radiotherapy, 5-fluorouracil, interferons, bleomycin, imiquimod 5%cream, tranilast, botulin toxin and surgical excision. silicone sheeting is considered first line therapy of hypertrophic scar. it works by maintaining hydration and occlusion at scar site. but silicone sheeting is expensive and need 12 to 24 hours of constant application daily for at least 2 months for desired results. level 1, 2 and 3 evidences show newer technique 'percutaneous collagen induction(micro-needling)', shows significant improvement in hypertrophic scars. micro-needling causes controlled dermal injury to initiate inflammatory and healing reaction, which in turn leads to remodelling of collagen and stimulate regeneration of scared skin. silicone sheets is an expensive treatment requiring multiple applications and are often difficult to use in hot and humid environment. these reasons often lead to poor patient compliance. keeping these issues in mind we planned to study an alternative option i.e. micro-needling, which is relatively of low cost and better patient acceptability. when doing the literature review the investigator found scanty evidence so the investigator decided to perform this rct.

Eligibility criteria:
1. all the patients presenting with hypertrophic scars ≥1cm in size 2. any age 3. both genders exclusion criteria: 1. pregnant or lactating mothers 2. patients who already taking systemic steroid as confirmed through clinical record 3. patients with renal failure or liver failure as confirmed through clinical history 4. patient with uncontrolled diabetes. 5. patients who received treatment for keloids or hypertrophic scar in past. 6. patients with active inflammation in area of hypertrophic scar or in its vicinity.
comparison of a nutritional anti-inflammatory treatment to steroids for pediatric crohn's disease - the molecular basis

Conditions: Crohn's Disease; Pediatric

Summary: the primary purpose of this study is to compare the efficacy of enteral nutrition compared to steroids in inducing remission of active pediatric crohn's disease. the main hypothesis of this study is that the use of enteral nutrition induces mucosal healing, whereas steroids do not. this effect may be related to a change of the commensal flora during enteral nutrition.

the precise and exact cause of crohn's disease (cd) remains still unknown. however, recent data point out to an inappropriate and exaggerated inflammatory response of the intestinal mucosal immune system toward intestinal commensal flora as initial trigger. several strategies were developed in the treatment of active cd. anti-inflammatory drugs such as steroids proved to be very helpful in the induction of a primary remission as is the use of exclusive enteral nutrition. besides a long standing experience with en in the management of cd in several centres, the mode of action and the molecular mechanisms of a specific en, such as modulen ibd ® remain still unknown. the ultimate aim of this study is to compare the efficacy of modulen ibd ® in inducing remission compared to steroids with a detailed analysis of the mucosal repair and anti-bacterial defence mechanisms within the inflamed intestinal mucosa and the composition of the commensal flora before and during therapy. this approach may help to elucidate the interaction between the intestinal mucosa and the commensal flora during the onset of cd and induction of remission.

Eligibility criteria:
inclusion criteria: crohn's disease active disease small bowel involvement exclusion criteria: antibiotic therapy within 4 weeks prior to inclusion immunosuppressive therapy within 4 weeks prior to inclusion not willing to collaborate isolated oral or perianal involvement

Keywords: enteral nutrition steroids mucosal healing
comparing mechanical power in different inspiratory times

Conditions: Ventilator-Induced Lung Injury; Acute Respiratory Distress Syndrome

Summary: we aimed to compare mechanical power and energy values using geometric methods at varying inspiratory rise times.

in this study, the researchers aim to compare the mechanical power and energy values calculated using the geometric method in volume-controlled ventilation (vcv) and pressure-controlled ventilation (pcv) modes at different inspiratory rise times.

Eligibility criteria:
inclusion criteria: * ards (acute respiratory distress syndrome) patients. * patients who are deeply sedated. * patients ventilated in: * pressure-controlled ventilation (pcv or prvc) mode, or * volume-controlled ventilation (vcv) mode. * patients within the 24-48 hour period of their stay in the intensive care unit. exclusion criteria: * patients with incomplete data. * patients diagnosed with: * copd (chronic obstructive pulmonary disease), * heart failure. * pregnant patients. * patients with a thoracopleural fistula. * hemodynamically unstable patients.
effect of uterine artery ligation prior to uterine incision in women with placenta previa

Conditions: Placenta Previa

Summary: pfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * the loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with no. 1 vicryl suture. myometrium was included so that uterine vessels are not damaged. * cresenteric lower uterine segment incision was performed as usual. higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta delivery of the baby and placenta. * closure of the uterine incision in 2 layers with n0. 1 vicryl suture. * closure of the anterior abdominal wall in layers

pfannenstiel incision of skin and opening of the anterior abdominal wall in layers. * the loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment. * uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with no. 1 vicryl suture. myometrium was included so that uterine vessels are not damaged. * cresenteric lower uterine segment incision was performed as usual. higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta delivery of the baby and placenta. * closure of the uterine incision in 2 layers with n0. 1 vicryl suture. * closure of the anterior abdominal wall in layers in the control group, lower segment caesarean section is without uterine artery ligation

Eligibility criteria:
inclusion criteria: * patients diagnosed with placenta praevia antenatally * plan is elective caesarean section * gestational age \>34 weeks exclusion criteria: * fetal distress * medical disorders as hypertension or diabetes mellitus * coagulation defects. * emergency cesarean section * women with antepartum hemorrhage * patients with marked ahdesions or those with non possible uterine artery ligation
the combination of sintilimab and ai (doxorubicin, adm/ifosfamide, ifo) for the first line treatment of select type of metastatic/unresectable soft tissue sarcoma

Conditions: Sarcoma, Soft Tissue

Summary: this is a phase ii trial to explore the feasibility of pd-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: * men and women aged 18-75 years; * provide written informed consent; * local advanced or metastatic unresectable sarcoma; * histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma; * performance status of 0 to 1 on the eastern cooperative oncology group (ecog) performance scale; * have measurable disease based on response evaluation criteria in solid tumors (recist) 1.1; * life span expectation over 3 months * absolute neutrophil count (anc) ≥1,500/mcl (within 7 days of treatment initiation) ； * hemoglobin ≥9 g/dl (within 7 days of treatment initiation) ； * platelets ≥ 90,000/mcl (within 7 days of treatment initiation) ； * serum creatinine ≤ 1.5 x upper limit of normal (uln) or creatinine clearance \[crcl\]) ≥ 50 ml/min for subject with creatinine levels (within 7 days of treatment initiation) ； * serum total bilirubin ≤ 1.5 x uln (within 7 days of treatment initiation) ； * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]) and alanine aminotransferase (alt) (serum glutamate pyruvate transaminase \[sgpt\]) ≤ 2.5 x uln or =\< 5 x uln for subjects with liver metastases (within 7 days of treatment initiation)； exclusion criteria: * prior systemic therapy for advanced and metastatic disease, except adjuvant treatment（not received anthracycline）replase over 6 months; * received any testing anti-cancer drugs within four weeks of treatment initiation; * prior immune related therapy including but not limited to pd-1, pd-l1, cd137, ctla4, t cell stimulation, check point inhibitor etc; * symptomatic, untreated, or uncontrolled brain metastases present * clinical meaningful active bleeding; * other malignant cancer history rather than soft tissue sarcoma within five year prior to treatment initiation; * have active infections requiring therapy; * have active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. patients that require inhaled steroids or local steroid injections would not be excluded from the study. patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study. * pregnant or breast-feeding； * any serious or unstable medical condition or mental illness； * serious systemic diseases such as heart disease, history of (non-infectious) pneumonitis; * active hbv （\>10000 copy/ml） and hcv （rna\> 1000copy/ml） infection； * positive human immunodeficiency virus (hiv）or any acquired immunodeficiency syndrome, organ implantation;

Keywords: pd-1 doxorubicin ifosfamide first line treatment
efficacy, safety, and tolerability of jnj-27018966 (eluxadoline) in the treatment of irritable bowel syndrome with diarrhea

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine the efficacy, safety, and tolerability of different doses of jnj-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (ibs-d).


Eligibility criteria:
key inclusion criteria: * patient has a diagnosis of ibs by rome iii criteria with a subtype of diarrhea * female patients must be: * postmenopausal, defined as amenorrhea for at least 2 years at prescreening, * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), * abstinent, or * if sexually active, be practicing an effective method of birth control. key exclusion criteria: * patient has a diagnosis of ibs by rome iii criteria with a subtype of constipation, mixed ibs, or unsubtyped ibs * patient has a history of inflammatory or immune-mediated gastrointestinal (gi) disorders including inflammatory bowel disease (ie, crohn's disease, ulcerative colitis) and celiac disease * patient has a history of diverticulitis within 6 months prior to prescreening * patient has a history of intestinal obstruction, stricture, toxic megacolon, gi perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states. other protocol-specific eligibility criteria may apply.

Keywords: irritable bowel syndrome with diarrhea irritable bowel syndrome diarrhea predominant irritable bowel syndrome colonic diseases colonic diseases, functional digestive system disease gastrointestinal disease intestinal disease colonic pseudo-obstruction diarrhea signs and symptoms, digestive