Kornimate/medical-research-clean huggingface dataset:
economic evaluation in cardiology: remote monitoring of pacemakers

Conditions: Cardiovascular Disease

Summary: the purpose of this research is to estimate the outcomes in health and cost of the follow-up of patients with pacemakers. the initial hypothesize of this study is that remote monitoring of pacemaker will show a best relation of outcomes in costs and effectiveness than the conventional follow-up in hospital.

cardiovascular diseases are a major cause of global morbidity and mortality, being responsible according to the world health organization of the 30% of overall mortality. since 2001 that the first pacemaker of remote monitoring was implanted in europe, more than 300,000 pacemaker have been implanted around the world. despite this sharp expansion, the scientific evidence on economic evaluations of pacemaker with remote monitoring is very limited, and in our knowledge, studies including informal costs have not been conducted. in the field of cardiology, telemedicine allows consultations with patients through monitoring systems and remote communication analyzing the ongoing heart rates of people with pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy and subcutaneous holter. the use of remote monitoring may save time and efforts to both healthcare professionals and patients, including their informal caregivers, reducing the number of follow up visits to the hospital and reducing the associated costs with patient follow-up, which will help to improve sustainability of healthcare services. during the 12 months of study, the patients with implant of pacemakers of both groups will be assessed of the same parameters, in 4 different moments (pre-implant and months 1, 6, 12 and 5 years post-implantation). the study will estimate: 1) the clinical features of the patients. 2) the effectiveness through of administration of health-related quality of life, functional capacity questionnaires and 3) finally, the hospital and informal costs of patients with pacemakers will be estimated by the researches.

Eligibility criteria:
inclusion criteria: * be 18 years of age * have a pacemaker implanted * understand and be able to properly perform self-monitoring at home exclusion criteria: * be participating in another study * refuse to participate in the study * have implanted a different cardiac device to the pacemaker

Keywords: follow-up studies biological pacemakers telemedicine efficiency
the longitudinal study of low anterior resection syndrome in patients with newly diagnosed rectal cancer.

Conditions: Rectal Cancer

Summary: the aims are to identify the trajectory of lar syndrome and explore the adaptation process and coping strategies of lar syndrome in patients newly diagnosed with rectal cancer. the participants will recruit from a crc surgical outpatient department of a medical center in northern taiwan.


Eligibility criteria:
inclusion criteria: 1. patients with stage i to iii rectal cancer. 2. patients already know their condition. 4. aged 20 years and older. 5. consciously communicate in mandarin or taiwanese. 6. agreed with the interview and had signed the permit. exclusion criteria: 1. patients with stage iv rectal cancer. 2. recurred rectal cancer.

Keywords: low anterior resection syndrome psychological distress quality of life rectal cancer
aquatic therapy for children with neuromotor deficits

Conditions: Cerebral Palsy; Hypoxia, Brain

Summary: the purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. the intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.

the purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention. the intervention will target swim safety skills, upper extremity function and self care participation and performance in children with neuromotor conditions such as cerebral palsy. the study includes an intake evaluation session, twenty sessions of aquatic therapy (twice a week for 10 weeks) and a post evaluation session. this takes place in columbus, ohio. each session will be a combination of land-based self care training and water-based upper extremity exercise and swim skill training. the intervention structure will include the following: 1. self care session: doffing clothing, preparing for swimming 2. motor learning aquatic activities guided by individualized goals 3. self care session: towel dry, rinse off, dressing individualized activities will be planned according to the individualized goals written for each child participant.

Eligibility criteria:
inclusion criteria: * 3-9 years for the children, 18+ for the parents/guardians. * child with neuro-motor diagnosis (cp, hypoxia, etc.) * child impairments in upper extremity function * child deficits in performance of self care activities exclusion criteria: * compromised airway * uncontrolled seizures
study of resistance to thyroid hormone after long-term exposure in people with thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this study is to find out whether people who have had thyroid cancer develop resistance to treatment with thyroid hormones after having received high doses of thyroid drugs for many years.


Eligibility criteria:
inclusion criteria: * age 18 or older * due to a diagnosis of thyroid cancer, patient underwent a total thyroidectomy based on pathology. * no evidence of active disease based on routine surveillance testing showing no suspicious findings on neck ultrasound and low thyroglobulin levels (≤1.0 ng/ml) with negative thyroglobulin antibodies within one year of study enrollment. for the study patients, this response can be evaluated after five years of tsh suppression. for control subjects, this response can be evaluated after two years of surveillance. * two groups: * 8 patients with a history of thyroid hormone suppression (tsh\<0.5 mu/l) for at least 5 years * 8 patients with no history of tsh suppression * normal tsh level based on the laboratory reference range for at least 6 months at the time of study enrollment. * blood pressure range of \>90/60 and \<180/100. patients may be included in the study if blood pressure has been treated with medication and normalized. exclusion criteria: * patient reported history of symptomatic heart disease including unstable angina or nyha stage iii or iv heart failure. * patient reported history of one of the following cardiac arrhythmias: atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, ventricular fibrillation, or ventricular tachycardia. * patient reported history of uncontrolled hypotension (\ 180/100). * history of renal dysfunction with creatinine more than 1.5 times the upper limit of normal based on recent laboratory testing * known hypersensitivity to the drug * pregnant or breast feeding * prior history of seizures or brain damage * patients on chronic therapy with levodopa * patients on therapeutic doses of acetylsalicylic acid (2 - 3.6 gm/day) * patients with conditions that result in disruption of the hypothalamic-pituitary axis (i.e. hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma).

Keywords: thyrotropin releasing hormone (trh) 20-079
turkish nationwide survey of glycemic and other metabolic parameters of patients with diabetes mellitus-2 (temd-2 study)

Conditions: Diabetes Mellitus

Summary: this study evaluates the metabolic control status, cardiovascular risk and frequency of comorbidities in diabetic patients followed in tertiary treatment centers in turkey.

diabetes mellitus is one of the most common chronic diseases worldwide.the prevalence of diabetes is increased significantly in türkiye, from 7.2 % in 2002 to 13.7% in 2012. this increasing prevalence leads to serious public health problems and a significant economic burden. many important diseases such as hypertension and dyslipidemia accompany the picture in diabetic patients. the optimal treatment of diabetes and prevention of diabetic complications, especially the cardiovascular outcomes, is utmost important. although achieving glycemic targets in patients with diabetes is of great importance, blood glucose is not the only predictor of cardiovascular outcome in diabetes. optimization of other metabolic parameters such as lipids, arterial blood pressure (abp), and body weight as well as a healthy lifestyle are utmost important. common problems in diabetic patients, such as sleep disorders and sexual dysfunction, affect glycemia regulation in these patients.there is little data on the frequency of these diseases in diabetic patients in türkiye. in the temd-1 study conducted in 2017, the rates of diabetic patients achieving metabolic goals and the factors affecting these rates were revealed in turkish patients with diabetes. the findings obtained in the current study will be compared with the findings in 2017, and in addition, the frequency of comorbidities such as sleep disorder, sexual dysfunction, and depression will be tried to be revealed.

Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes * upper than 18 years old * to be under follow-up in the same center for at least one year. exclusion criteria: * pregnant or lactation period * younger than 18 years old * history of psychiatric disorders interfering cognition or compliance

Keywords: glycemic regulation metabolic control sleep disorder sexual dysfunction depression
effect of lactobacillus plantarum 299v supplementation on major depression treatment

Conditions: Depression; Anxiety Disorder

Summary: the aim of the study is to determine the influence of supplementation of probiotic lactobacillus plantarum 299v vs. placebo of probiotic during antidepressant monotherapy with ssri (selective serotonin reuptake inhibitor) in patients with major depression.

for period of 8 weeks patient will receive probiotic lactobacillus plantarum 299v or its placebo as a supplementation of regular depression treatment with ssri (escitalopram or sertraline). psychometric and biochemical parameters will be monitored and evaluated. at day one, after 3 weeks (day 21) and after 8 weeks (day 56) of the study psychometric parameters will be measured such as hamilton depression rating scale, pss-10 scale, scl-90 scale. at day one and after 8 weeks (day 56) of the study cognitive functions will be measured using: cvlt- california verbal learning test, rfft ruff figural fluency test, stroop test, connecting points test (a and b), attention and perceptivity test. at day one and after 8 weeks (day 56) of the study biochemical parameters will be measured such as: morning cortisol, pro and anti-inflammatory cytokines, tryptophan and its kynurenic pathway metabolites concentrations.

Eligibility criteria:
inclusion criteria: * unipolar depression, with at least one depressive episode, present episode since at least 2 weeks, with hamilton depression scale scoring 18 and higher with bmi =18,9 - 29,9 kg/m2 exclusion criteria: * inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases, autoimmunological diseases * metabolic diseases e.g. diabetes type i,ii, obesity (body mass index)\>30 kg/m2 * previously diagnosed other psychiatric diseases other than depression, psychoactive substances abuse, organic brain dysfunctions * smokers * patients after surgeries in last 3 months * oncological patients * patients during pregnancy or lactation * drugs which might influence measured parameters (e.g. lithium, antibiotics, glucocorticosteroids, antipsychotic drugs) * changes in routine blood biochemical parameters: morphology, electrolytes, aspartate aminotransferase (ast), alanine aminotransferase (alt), creatinine, urea, c-reactive protein (crp), thyroid-stimulating hormone (tsh).

Keywords: depression microbiota-gut-brain axis lactobacillus plantarum 299v probiotic
effect and safety of polyethylene glycol combined with linaclotide on colon cleansing for patients with chronic constipation

Conditions: Bowel Preparation

Summary: constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.

colonoscopy is an important method to screen, diagnose and treat colon lesions. the quality of bowel preparation is requisite for the accuracy of diagnosis and safety of treatment. to explore the application effect and safety of linaclotide combined with compound polyethylene glycol electrolyte powder on colon cleansing before colonoscopy in patients with chronic constipation. a prospective mult-centers, colonoscopist-blinded study was conducted. a total of 300 patients with constipation who underwent colonoscopy in 8 hospitals from july to december 2021 were selected as study subjects and divided into the control group, observation group 1, observation group 2 and observation group 3 by random number table method, with 75 cases in each group. intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.

Eligibility criteria:
inclusion criteria: * inclusion criteria included: the inclusion criteria were patients ≥18 years old suffering from≥2 of the following criteria of chronic constipation under the rome iv standard: straining, hard stool, residual stool feeling, occlusion feeling, manual bowel movement(bm) performed ≥25% of overall bms, and bm frequency\<3 times a week . a chronic status was defined as symptoms being present for at least six months, with the symptoms described above being present for at least three months. exclusion criteria: * exclusion criteria included: (1)age \ 75; (2) severe chronic renal failure, severe congestive heart failure and liver dysfunction ;(3)with uncontrolled hypertension, diabetes, intestinal obstruction, intestinal perforation and electrolyte disorders, inflammatory intestinal disease and other organic gastrointestinal diseases;(4)with neurologic, endocrine, or metabolic disorders;(5)treatment with other gastrointestinal drivers, laxatives, and antilaxatives within nearly 2 weeks;(6)history of colorectal surgery;(7) dysphagia; (8) compromised swallowing reflex or mental status;(9)with consciousness disorders or examination intolerance;(10)pregnancy or lactation;(11)allergic to the drug composition;(12)suspected history of alcohol or substance abuse; (13)recent participants in clinical trials; (14) unable to give informed consent.

Keywords: chronic constipation colonoscopy linaclotide
a study to assess the efficacy of erlotinib for leptomeningeal carcinomatosis in egfr mutation positive non-small cell lung cancer

Conditions: Leptomeningeal Carcinomatosis; Non-small Cell Lung Cancer

Summary: to assess the efficacy and safety of erlotinib for non-small cell lung cancer patients with leptomeningeal carcinomatosis


Eligibility criteria:
inclusion criteria: 1. age \>18 2. histologically or pathologically proven non-small cell lung cancer (nsclc) 3. leptomeningeal carcinomatosis confirmed by csf cytology 4. a patients with egfr mutation (including exon 19 deletion, l858r) 5. ecog performance status 0-3 6. expected life time more than at least 4 weeks 7. a patients who signed the informed consent prior to the participation in the study 8. chemotherapy-naïve patient is eligible 9. previous egfr tki is allowed if this drug was not specifically used for cns metastases exclusion criteria: 1. a pregnant or lactating patient 2. a patient of childbearing potential without being tested for pregnancy at baseline or with a positive test. (a postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.) 3. a man or woman of childbearing potential without the willingness to use a contraceptive measures during the study 4. a patient with history of another malignant disease within past 3 years, except curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and early gastric cancer 5. a patient with active interstitial lung disease, except simple lymphangitic lung metastasis 6. a patient with history of allergic reaction to gefitinib or erlotinib 7. the following laboratory test results: * number of absolute neutrophils counts (anc) \< 1.0ⅹ109/l * number of platelets \< 50 ⅹ109/l * ast, alt \> 2.5 ⅹupper limit of normal * total bilirubin \> 1.5 ⅹupper limit of normal * serum creatinine \> 1.5 ⅹupper limit of normal 8. a patient with serious disease as followings * uncontrolled cardiac arrhythmia * history of myocardial infarction within 6 months prior to the initiation of study * neurological or psychiatric disorder including dementia or uncontrolled seizure 9. a patient who refused to sign the informed consent

Keywords: egfr mutation erlotinib lung cancer leptomeningeal carcinomatosis in egfr mutation positive non-small cell lung cancer
using mini program for self-management vs conventional pharmaceutical care for cancer pain

Conditions: Cancer Pain

Summary: with the existing medical system and insufficient medical resources in china, we developed a mini program. a pain management mini app can be useful and appreciated by patients and health care professionals, making it a good choice for the management of cancer pain in our country . our study want to develop and test the mini program for pain management among chinese cancer patients in or discharged from hospital treatment.

healthcare interventions delivered via personal mobile device have been shown to be acceptable to users, who have identified benefits such as convenience, access to personalized information, greater awareness of own health. integrating mini program into the cancer pain care may be an effective strategy to improve cancer pain patients self-management. to design, construct, and test the mini program in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in medicine compliance to improve pain management for cancer pain patients, and assess patient acceptance of the mini program.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older; * be able to read chinese and use a mobile phone; * histologically or cytologically confirmed solid tumor; * diagnosed chronic cancer pain * could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form. exclusion criteria: * illiterate person; * incompetence; * inability to complete the pain assessment; * participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study;

Keywords: mini program, self management, cancer pain
pooled analysis of clinical data from six gsk studies to investigate the efficacy of a dentifrice containing 67% weight by weight (w/w) sodium bicarbonate on gingivitis and plaque accumulation

Conditions: Gingivitis; Dental Plaque

Summary: the aim of this analysis was to pool data from 6 gsk studies with similar clinical design to investigate the overall efficacy of a test dentifrice containing 67% w/w sodium bicarbonate in the treatment of gingivitis and plaque accumulation after 6, 12 and 24 weeks of twice-daily brushing at home relative to a negative control dentifrice. the pooled analysis was planned and conducted after completion of all six independent studies.

this pooled analysis was performed on data collated from six gsk studies that provide efficacy data supporting the twice-daily use of a dentifrice containing 67% w/w sodium bicarbonate in the management of pre-existing gingivitis, and plaque accumulation. six studies that were chosen for inclusion in the pooled analysis were single-center, examiner-blind, 2 to 3 treatments, parallel group, stratified and randomized clinical study. in all studies, participants entered the screening period during which eligibility for the study was determined. the participants included male and non-pregnant, non-lactating female subjects at least 18 years of age with pre-existing gingivitis as determined by an appropriately qualified clinical examiner. participants meeting the inclusion criteria entered an acclimatization period in order to minimize any potential placebo response. participants were randomized into treatments, parallel group, stratified and randomized clinical studies twice daily at home for 6, 12 and 24 weeks and participants returned to the site. participants underwent a full ost examination and the recording of any adverse events (aes). participants then underwent modified gingival index (mgi), bleeding index (bi), gingival severity index (gsi) followed by dental plaque assessments.

Eligibility criteria:
inclusion criteria: * clinical studies conducted by gsk ch, including access to study protocols, study reports, and access to individual information sources/ study data. * study design and subject inclusion criteria in agreement with guidelines to assess gingivitis efficacy such as inclusion of a pre-treatment full-mouth prophylaxis, subject eligibility (\>20 bleeding sites and mild-moderate gingivitis at screening);comparable indices of gingivitis and plaque accumulation; a treatment for a 67% w/w sodium bicarbonate dentifrice; repeat brushing for at least a period of 4 weeks or 4-6 weeks. exclusion criteria: not applicable

Keywords: plaque accumulation
safety and pharmacokinetics of antipsychotics in children 2: studying tdm in an rct

Conditions: Autism Spectrum Disorder

Summary: the aim of this study is to test whether therapeutic drug monitoring of risperidone in children with autism spectrum disorder and comorbid behavioral problems is able to reduce metabolic side effect burden, while retaining clinical effectiveness.


Eligibility criteria:
inclusion criteria: * age 6 to 18 years * documented clinical diagnosis of autism spectrum disorder according to dsm iv or dsm v and comorbid behavioural problems * to start treatment with risperidone exclusion criteria: * diabetes type i or ii * congenital or acquired syndrome associated with changes in appetite, body weight or lipid profile (e.g. prader willi) * treatment with antipsychotic medication within the last 6 months * known long qt syndrome (lqts) * pregnancy

Keywords: risperidone therapeutic drug monitoring
evaluating factors in study experiences of lymphedema patients

Conditions: Lymphedema

Summary: the study intends to investigate the personal experiences of lymphedema patients who take part in a separate clinical trial including a specific medication intervention. the major focus will be on closely following individuals' rates of trial completion and withdrawal. the data collected from this study will help improve future outcomes for all lymphedema patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patients diagnosed with lymphedema * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * refusal of consent * women of childbearing potential without a negative pregnancy test; or women who are lactating. * any serious and/or unstable pre-existing medical disorders

Keywords: lymphedema