Kornimate/medical-research-clean huggingface dataset:
perioperative monitoring to assess preoperative anxiety in inflammatory bowel disease patients

Conditions: Inflammatory Bowel Diseases; Surgery

Summary: anxiety and depression are extremely common among inflammatory bowel disease (ibd) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. this study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and heart rate variability (hrv) with the howdy senior ® device (comftech srl). additionally, the study will also investigate the feasibility and effectiveness of the howdy senior® device in improving the postoperative patient's monitoring.

inflammatory bowel disease (ibd) patients are at high risk of postoperative complications and delayed recovery. preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. this correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ecg) devices. the howdy senior® device (comftech srl) allows the real-time remote ecg monitoring and the computation of stress and fatigue indexes. the howdy senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge. this study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the howdy senior® device for the postoperative patients' remote monitoring.

Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old. * established crohn's disease (cd) or ulcerative colitis (uc) at the time of surgery indication with a proven histological diagnosis. * patients scheduled for elective intestinal resection. exclusion criteria: * diagnosis of undetermined colitis. * recurrent disease. * concomitant diagnosis of malignancy. * established diagnosis of major depressive disorder or anxiety disorder. * diagnosis of ventricular or supraventricular arrythmia. * active pharmacological treatment with β-blockers or other drugs affecting the heart rate. * known hypersensitivity to cotton or silver. * emergent surgery. * planned open surgery. * any concomitant surgery unrelated to the main surgical indication. patients undergoing perianal surgery for related perianal disease can be included in the study.

Keywords: inflammatory bowel disease surgery anxiety and depression
microplastics and nanoplastics (mnps) in patients with st-elevation myocardial infarction (stemi)

Conditions: ST-elevation Myocardial Infarction (STEMI); Microplastics; Nanoplastics; Pollution Exposure

Summary: air pollution and microplastics pose major public health threats. emerging data have shown that micro- and nanoplastics (mnps) are ubiquitous environmental pollutants accumulating in human tissues, triggering inflammation and prothrombotic state. this study will investigate the presence and burden of mnps within coronary thrombi/thromboaspirate of patients presenting with st segment elevation acute myocardial infarction (stemi) undergoing primary percutaneous coronary intervention and their association with cardiac damage, plaque vulnerability, microvascular obstruction, and cardiovascular events. plaque vulnerability will be explored by optical coherence tomography, while microvascular obstruction will be assessed by bolus thermodilution and cardiac magnetic resonance. participants will be followed up for 1-year to evaluate whether the presence and the burden of mnps will be associated with a higher incidence of the cardiovascular events.


Eligibility criteria:
inclusion criteria: all the following inclusion criteria should be fulfilled: 1. age \> 18 years old; 2. stemi undergoing urgent invasive coronary angiography; 3. acute thrombotic coronary occlusion/sub-occlusion (timi 0/1); 4. clinical indication to thromboaspiration; 5. able to give informed consent. exclusion criteria: 1. contraindications to percutaneous coronary intervention; 2. hemodynamic instability or cardiogenic shock; 3. end-stage chronic kidney disease; 4. life expectancy \< 1 year due to non-cardiac pathology.

Keywords: stemi microplastics nanoplastics inflammation oct plaque composition cardiac magnetic resonance pollution exposome infarct size coronary microvascular dysfunction imr mrr
incremental hemodialysis: the twoplus trial

Conditions: End-Stage Kidney Disease

Summary: this study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function. the study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. caregivers will be followed along with patients for an average period of 2 years post randomization.

this study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with kidney dysfunction requiring dialysis (kdrd) and appreciable kidney function. this study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.

Eligibility criteria:
patient eligibility criteria: inclusion criteria: * clinical inclusion criteria: * age ≥ 18 years * incident kidney dysfunction requiring dialysis (kdrd) started on maintenance, in-center hemodialysis (hd), or anticipated to be started on maintenance, in-center hd within the next 12 weeks * has received ≤36 sessions of intermittent hd (i.e., on hd for ≤12 weeks) at the time patient is approached for potential study participation residual kidney function inclusion criteria: * kidney urea clearance \<2.0 ml/min * urine volume# of ≥500 ml/24 h exclusion criteria: * pre-hd serum k ≥5.8 meq/l, na ≤125 meq/l, or bicarbonate level ≤17 meq/l * requirement or anticipated requirement of high-volume ultrafiltration * unable or unwilling to follow the study protocol for any reason * known pregnancy or planning to attempt to become pregnant or lactating women * estimated survival or dialysis modality change or center transfer \<6 months caregiver eligibility criteria: * be at least 18 years old * be the main caregiver (at patient's choice) * be a close relative of the patient (spouse, child, sibling, parent, grandchild) * have no known psychiatric and neurologic disorders (through direct inquiry from the person) * not be a member of the medical or healthcare team * not be the caregiver for another patient with chronic illness * not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)

Keywords: hemodialysis clinically-matched incremental hemodialysis
orthopaedic manipulation in treatment of adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: to examine the clinical efficacy of the orthopaedic manipulation techniques of the lin school of lingnan region in the treatment of adolescent idiopathic scoliosis

after being informed about the study and potential risk, all patients giving written informed consent will undergo a 0-week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be randomized in a single-blind manner(participant) in a 1:1 ratio to manipulation techniques group or control group.

Eligibility criteria:
inclusion criteria: 1. adolescents aged between 10 and 18 who can speak and read chinese 2. fulfil the diagnostic criteria of scoliosis, i.e. cobb's angle ≥ 10 degree 3. risser grade ranging from 0 to 4 4. informed consent agreement signed by both subject and their parents/guardians 5. able to participate in follow-up assessments exclusion criteria: 1. history of spine surgery; 2. cobb's angle \>30 degrees 3. known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; leukaemia, thrombocytopenia and other bleeding disorders 4. known to have cognitive impairment. 5. documented pregnancy 6. wearing brace within 1 month. 7. involved in other interventional clinical studies at the same time. 8. uncooperative during treatments 9. being assessed by investigators as unsuitable to participate.
hair fall in patients on low dose methotrexate

Conditions: Alopecia; Rheumatoid Arthritis; Methotrexate Adverse Reaction

Summary: low dose methotrexate used in rheumatoid arthritis is considered very safe and has a side effect profile very different from that seen with high dose methotrexate used in oncology. hair fall has been found to occur in high dose methotrexate but there is no data regarding the same when methotrexate is used in low dose.thus this observational case control study is being undertaken to determine whether rheumatoid arthritis patients really need to be concerned about hair fall when on low dose methotrexate.


Eligibility criteria:
inclusion criteria: for cases * subjects should be above 18 years of age. * diagnosed with rheumatoid arthritis and fulfilling the acr eular 2010 criteria. * should be initiated on methotrexate * willing to follow up for controls -subjects should be above 18 years of age. exclusion criteria: for cases * subjects with prior exposure to methotrexate in the last 6 months * subjects suffering from thyroid (hypothyroidism) * subjects on leflunomide, or having received leflunomide in the last 6 months * subjects currently on cyclophosphamide or having received cyclophosphamide in the last 3 months. * subjects on psychiatric treatment or depression illness. * subjects who have overlap with other rheumatological disorders which can cause hair fall. * subjects in 1-5 months of post-partum or post-natal period. * subjects with female pattern baldness * subjects with androgenetic alopecia * subjects with alopecia aereta * subjects with other scalp conditions which can predispose to hair fall for controls * subjects having any family history of alopecia. * subjects suffering from thyroid. * subjects having any history of anemia. * subjects under 1-5 months of post-partum or post-natal period. * subjects on medications which can cause hair fall. * subjects on methotrexate for other reasons. * subjects with female pattern baldness * subjects with androgenetic alopecia * subjects with alopecia aereta * subjects with other scalp conditions which can predispose to hair fall
an eortc study updating the qlq-br23 to br45

Conditions: Cancer; Breast Cancer

Summary: female breast cancer is still the most frequent type of cancer in europe with 21 per 100,000 women .the eortc qlq-br23 was one of the first modules developed to be used in conjunction with the core questionnaire eortc qlq-c30 and was published in 1996. since the beginning of the work on the eortc qlq-br23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. therefore, the eortc quality of life group decided to update the bc23. a phase 1 to 3 module development project has been completed. this resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. the aim of the phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the eortc qlq-bc45 in conjunction with the eortc qlq-c30 in patients diagnosed with breast cancer. participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. various combinations of therapies are permissible. according to sample size calculations, we will include a total of n =490 patients from 12 countries. participants will be invited to complete the qlq-c30 and the qlq-bc45, followed by the debriefing questionnaire. data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. a subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the qlq-c30 and the qlq-bc45 for a second time one to two weeks later for the test-retest analysis. a subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. sociodemographic and clinical data will be recorded using standardized case report forms (crf).


Eligibility criteria:
inclusion criteria: * adult females aged 18 years or over * histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour * receiving or have previously received curative or palliative treatment. * able to understand/speak english and complete the questionaires * have the capacity/mental fitness to give written informed consent and complete the questionnaires. exclusion criteria: * male gender or transgender * inability to understand/speak english and complete the questionnaire * patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.

Keywords: eortc pro prom adverse event quality of life
comparison of gas exchange between two invasive mechanical ventilation modes in children

Conditions: Respiratory Failure

Summary: this study assesses the feasibility of digital data collection for a randomized controlled trial in a quaternary pediatric intensive care unit and the effect of two commonly used mechanical ventilation modes on gas exchange (co2) in children over 2 days after randomization. this is a single-center, open-labelled, randomized controlled trial with two parallel 1:1 treatment arms: pressure controlled (pc) vs pressure-regulated volume controlled (prvc) mechanical ventilation modes. use to routine digital data is essential to enable health learning systems and to provide rapid clinical trials readiness, as the pandemic has demonstrated. despite availability of data to perform digital trials in picu settings, these are yet scarcely done.


Eligibility criteria:
inclusion criteria: * informed consent provided by the participant or the participant's parents or legal guardians. in case of an emergency situation, a physician who is independent of the research project must be consulted prior to inclusion in order to safeguard the interests of the test subject. * admission to picu at the university children's hospital zurich * need for mechanical ventilation for \>60 min during picu hospitalization. need for mechanical ventilation will be based on clinical decision of the treating physician. * need for an arterial line during picu hospitalization. need for an arterial line will be based on clinical decision of the treating physician. * age \<18 years * weight \>2 kg exclusion criteria: * substantial air leaks around the endotracheal tube (\>30%) * cyanotic shunt lesions * intracranial hypertension (i.e. traumatic brain injury or patients admitted after neurosurgery) * pulmonary hypertension under treatment (i.e sildenafil or inhaled nitric oxide) * time from start of invasive mechanical ventilation until time of screening is \> 24 hours * previous enrolment in the study in the past 30 days * inability of the parents or legal guardians to understand the study due to linguistic or cognitive reasons

Keywords: pediatrics child infant mechanical ventilation pressure control pressure regulated volume control randomized controlled trial
effect of vardenafil on erectile dysfunction and portal hemodynamics in patients with liver cirrhosis

Conditions: Cirrhosis; Erectile Dysfunction

Summary: the investigators want to analyze the effect of vardenafil on erectile dysfunstion and portal hemodynamics in patients with liver cirrhosis.

2 phase 2 arm study phase a: baseline hvpg (hepatic venous pressure measurement) measurement, followed by 1 capsule of 10mg vardenafil or placebo (randomization 1:1) daily per oral for 7 days, hvpg measurement at day 7 phase b: 1 capsule of 10mg vardenafil or placebo (randomization 1:1) ad libidum per oral for 28 days

Eligibility criteria:
inclusion criteria: * male patients aged older than 18 years with mild to moderate (child´s grade a or b) cirrhosis scheduled for hepatic hemodynamic investigation. * erectile dysfunction in medical history * following beta-blocker therapy will be allowed: carvedilol (up to the max. dose of 25 mg) and propranolol (up to the max. dose of 160 mg) * patient living in a stable relationship * hvpg (hepatic venous pressure measurement)\>= 10 mmhg exclusion criteria: * hvpg \<10 * hvpg \> 20 mmhg and varices, unless ligated and treated in an eradication program within 6 months * history of variceal bleeding without secondary prophylaxis with beta blocker or endoscopic band ligation * history of endoscopically diagnosed large varices with red spots without previous bleeding and without prophylactic beta blocker or endoscopic band ligation * history of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure * treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study * exclusion criteras for hepatic hemodynamic investigation * cardiac, renal or respiratory failure * previous surgical or transjugular intrahepatic portosystemic shunt * insulin-dependent diabetes * child´s grade c cirrhosis

Keywords: cirrhosis erectile dysfunction portal hypertension
bronchial challenge test of magnesium-treated asthmatics

Conditions: Asthma

Summary: the present study is part of a project titled 'magnesium in asthma and chronic obstructive pulmonary disease'. the hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease. the aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.


Eligibility criteria:
inclusion criteria: * asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (pd20\<1000 microgram exclusion criteria: * se-mg \> 2,00 mmol/l, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Keywords: bronchial challenge test hyperreactivity pd20 for metacholine daily magnesium supplement
toothwave plaque and gingivitis study

Conditions: Gingivitis; Plaque; Calculus, Dental

Summary: the objective of the study is to evaluate the safety and efficacy of the home-use device silk'n toothbrush (toothwave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.

this is a single blind, prospective study aimed to evaluate the safety and efficacy of the silk'n toothbrush in reduction of gingivitis, dental plaque and calculus. the study includes 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks. one treatment group (silk'n toothbrush - toothwave) and 1 control group (an ada approved power toothbrush (ptb)) will participate in the study. for each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. the average data sets will be calculated for each group. treatment is defined as a timed 2 minutes of teeth brushing in a regular man-ner, twice a day (morning and evening). brushing will be undertaken using the silk'n toothbrush and standard fluoride toothpaste. the control group will use a regular ptb and standard fluoride toothpaste.

Eligibility criteria:
inclusion criteria: 1. adult subjects aged 18-70, that are in good health. 2. subject must have: 2.2. baseline gingivitis (mgi) score of at least 1.80, 2.3. dental plaque mean score greater than 0.6 according to the rmnpi index. 2.4. total calculus deposits greater than 7 according to the volpe-manhold index. 3. have a minimum of 20 'scorable' teeth (excluding 3rd molars). 4. the subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. subjects will sign the informed consent form. 5. the subjects should be willing to comply with the study procedure and schedule, including the follow up visits. exclusion criteria: 1. current or history of oral cavity cancer or oropharyngeal cancer. 2. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. 3. pregnant or nursing by subject report. 4. any active condition in the oral cavity at the discretion of the investigator. 5. any surgery in the oral cavity within 3 months prior to treatment, or before complete healing. 6. subjects that do not brush regularly. 7. any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
optimal treatment protocol for selective laser trabeculoplasty

Conditions: Glaucoma, Open-Angle; Pseudoexfoliation Glaucoma; Ocular Hypertension

Summary: a randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

a randomized controlled trial in which individuals scheduled for slt are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use. treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mj) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). this gives four treatment arms: 180/low, 180/high, 360/low and 360/high. group allocation is masked for the patient and is coded in the records. the results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

Eligibility criteria:
inclusion criteria: * diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension. * intra-ocular pressure (iop) at least 18 mmhg treatment day. * treatment is performed by an experienced laser surgeon. * slt treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient. exclusion criteria: * change of iop-lowering medication during the last three months. * planned change of intra-ocular-pressure-lowering medication. * previous glaucoma surgery (other than slt and alt) * previous intra-ocular surgery during the last three months. * previous intra-ocular inflammatory disease during the last year. * planned intra-ocular surgery. * hyper-pigmented anterior chamber angle.

Keywords: selective laser trabeculoplasty