Kornimate/medical-research-clean huggingface dataset:
sorry not sorry: apologizing and its effect on discomfort during dressing removal

Conditions: Bandages; Pain; Empathy

Summary: use of dressing is common place following surgery, allowing for wounds to be covered and protected. dressing material with adhesive contact layers or adhesive tape is integral to sealing off the wound. mechanical stripping of stratum corneum during dressing removal causes pain and discomfort. during dressing removal, practitioners may at times apologize as a function of empathy. previous study investigated speed of dressing removal and its effect on discomfort during dressing change. in this study, the investigators aim to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?


Eligibility criteria:
inclusion criteria: * healthy adult volunteers, age \>18. exclusion criteria: * individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.

Keywords: pain empathy dressing change
feasibility and efficacy of pro-mamas

Conditions: Chronic Stroke

Summary: this experimental design will assess the feasibility \& initial effectiveness of pro-mamas (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) - a novel occupational therapy intervention program to promote participation, health and wellbeing of older mothers with chronic stroke. assessments will be conducted at three time points: baseline, pre, post the pro-mama intervention

this study aims to test the feasibility and initial effectiveness of pro-mamas (promoting participation, health and wellbeing through meaningful maternal-role activities after stroke) in improving participation, health and wellbeing among older community dwelling mothers with chronic stroke. pro-mamas is a group intervention that aims to promote the health and wellbeing of older mothers with chronic stroke by using meaningful maternal-role activities as a motivational mean for participation. the intervention will include group discussions and practice, analysis of facilitators and barriers for participation, and home exercise. pro-mamas will focus on raising awareness to meaningful maternal-role activities, identifying facilitators and barriers for participation and problem solving to enhance meaningful participation.

Eligibility criteria:
inclusion criteria: * women * aged 70 and older * mothers (have at least one live and healthy child) * with chronic stroke (at lease six months from stroke onset) * that live at home * that they can walk independently (with or without a walking aid) * without significant cognitive decline (moca ≥19)
efficacy of pencil pushup exercise vs base out exercising prism's in patient with convergence insufficiency

Conditions: Convergence Insufficiency

Summary: convergence insufficiency (ci) is a prevalent binocular vision disorder that leads to symptoms such as eye strain, headaches, and blurred vision during near work. this study aims to evaluate and compare the efficacy of pencil pushup exercises versus base-out exercising prisms in the management of ci. a randomized controlled trial (rct) will be conducted with 28 participants, using non-probability convenience sampling from sighton optix, lahore. participants will be randomly assigned to either the experimental group (receiving base-out exercising prisms) or the control group (receiving pencil push up exercises). the study will assess symptom improvement using the convergence insufficiency symptom survey (ciss), near point of convergence (npc).

the study will also evaluate quality of life (qol) using a vision-related qol questionnaire. the total study duration is 3 months, with a primary goal of determining the relative efficacy of these two interventions. this study is expected to provide valuable insights into effective, evidence-based management options for convergence insufficiency, ultimately improving patient outcomes and guiding clinical practice. the collected data will be analysed by using spss.

Eligibility criteria:
inclusion criteria: * patients having ciss score more than 16 or higher for children aged \<21 and 21 or higher for adults. * patients diagnosed with convergence insufficiency based on clinical tests (e.g., near point of convergence). * age group: 10-50 * patients experiencing symptoms related to convergence insufficiency, such as eye strain, headaches, blurred vision, or double vision during near work. * able to perform pencil push-up exercises correctly after demonstration. * no other significant ocular or neurological conditions that might affect vision or convergence. exclusion criteria: * any type of strabismus. * amblyopia. * refractive error more than 6 diopters. * patients with history of prism prescription. * history of strabismus surgery or refractive error surgery. * history of eye trauma. * any systemic and neurological diseases affecting binocular vision such as diabetes, myasthenia gravis, graves', and multiple sclerosis.
effect of metformin on patients with osteoarthritis

Conditions: Osteoarthritis

Summary: this randomized controlled trial aims to investigate if metformin has osteoarthritis protective effects among overweighted knee osteoarthritis patients. the co-primary outcomes are changes in tibiofemoral cartilage volume and western ontario and mcmaster universities arthritis index (womac) from baseline to month 24. the secondary outcomes are changes in visual analog scale (vas)-assessed knee pain, tibiofemoral cartilage defect, effusion-synovitis volume, and tibiofemoral bone marrow lesion maximum size from baseline to month 24.


Eligibility criteria:
inclusion criteria: 1. meet the american college of rheumatology (acr) criteria for symptomatic knee osteoarthritis assessed by a rheumatologist; 2. age 50 to 75 years; 3. body mass index ≥ 24 kg/m2; 4. knee pain ≥ 20 on a 100 mm visual analogue scale (vas); 5. able to listen, speak, read and understand chinese; capable of understanding the study requirements and willing to cooperate with the study instructions; able to provide written, informed consent. exclusion criteria: 1. severe radiographic knee oa as grade 3 joint space narrowing according to the osteoarthritis research society international (oarsi) atlas; 2. severe knee pain as knee pain ≥ 80 on a 100 mm vas; 3. planned knee or hip surgery (including arthroscopy, joint replacement, and joint open operation) within 2 years; 4. severe knee trauma history (including arthroscopy, severe injury of knee ligament or meniscus); 5. contraindication to mri scanning (e.g. implanted pacemaker, artificial metal valve or cornea, aneurysm clipping surgery, arterial dissection, metal foreign bodies in the eyeball, claustrophobia); 6. other forms of inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis); 7. active malignant cancer or other life-threatening diseases; 8. type 1 or type 2 diabetes mellitus; 9. clinical manifestation of liver dysfunction or alanine aminotransferase/aspartate aminotransferase exceeding 2 times the upper limit of normal value; 10. estimated glomerular filtration rate less than 60 ml/min/1.73 m2; 11. hypoxic state (e.g. chronic heart insufficiency, acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, cor pulmonale, peripheral vascular disease); 12. alcoholism; 13. pregnancy or lactation; 14. allergic to metformin hydrochloride; 15. conditions affecting the absorption of oral drugs (e.g. postgastrectomy and malabsorption syndrome); 16. use of metformin in recent 30 days or plan to use metformin in the next 2 years; 17. use of investigational drug in recent 30 days.
impact of art therapy on fatigue and quality of life of patients treated with adjuvant radiotherapy for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to compare intervention by art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.


Eligibility criteria:
inclusion criteria: * breast cancer surgery (invasive or in situ) by conservative surgery * age ≥ 18 years * indication of adjuvant radiotherapy * adjuvant chemotherapy allowed * agreeing to participate in a clinical study * able to participate in a clinical trial exclusion criteria: * metastatic breast cancer * personal history of breast cancer

Keywords: breast cancer fatigue quality of life art-therapie adjuvant radiotherapy
nasal allergen challenge in rhinitic subjects

Conditions: Asthma; Allergic Rhinitis

Summary: background: nasal allergen challenge (nac) is useful to study the pathophysiology of rhinitis, and multiple challenges may more adequately approximate natural exposure. objective: to determine the effect of 4 consecutive daily nac, on clinical and inflammatory parameters in rhinitics with or without asthma.

the study will be performed outside the pollen season. on a baseline visit, 2 to 7 days prior to control challenge, allergy skin prick tests and methacholine inhalation test will be done. prior to first allergen challenge, skin titration will be done using tenfold dilutions of the allergen chosen for nasal challenges. subsequent to baseline visit, a control challenge will be done, followed, a week later, by repeated nacs. nacs will be done over 4 consecutive days, in the morning. nasal peak inspiratory flows (npif), oral peak expiratory flows (pef), and symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on each challenge day. induced sputum and nasal lavage specimen will be obtained 7 hours following the control challenge and the first and last nac.

Eligibility criteria:
inclusion criteria: * to have a positive reaction to one or more allergen on prick tests. * non smokers * no respiratory track infection for at least one month prior to the study. * positive reaction to cat hair and/or house dust mite (dermatophagoides pteronyssinus) aeroallergens on allergy skin prick tests and report rhinitis symptoms when exposed to an environment containing this allergen. * asthmatic subjects using only inhaled beta-2 agonists on an as needed basis for their asthma treatment. * asthmatic subjects with a history of asthma of at least 6 months. * asthmatic subjects with pc20 methacholine lower or equal to 8 mg/ml. * allergic rhinitic subjects never experienced any asthma symptoms or took any asthma medication in the past. * allergic rhinitic subjects with a provocative concentration of methacholine (pc20 higher than 16 mg/ml. exclusion criteria: * smokers or ex smokers less than 6 months or more than 10 pack-years. * asthmatic subjects using or used in the past 3 months inhaled or oral corticosteroids.
a study to find out how much mirabegron gets into the body after dosing with a tablet formulation

Conditions: Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects

Summary: a study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.

all participants will receive both oral and iv formulations, separated by a washout period. treatment arm a will receive a lower dose of mirabegron; treatment arm b will receive a higher dose of mirabegron.

Eligibility criteria:
inclusion criteria: * body weight between 60.0 and 100.0 kg and body mass index between 18.0 and 30.0 kg/m2 exclusion criteria: * known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used * clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine \>150 ųmol/l; asat, alat or ldh\> 2x uln; ɣ-gt \> 3x uln and/or abnormal serum bilirubin * any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug * subjects taking β blockers or β agonists (eye drops allowed) * any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to the first admission to the research unit * any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, ophthalmologic, renal, hepatic, neurological, dermatological, psychiatric or metabolic * any clinically significant abnormality following the investigator's review of the pre-study physical examination, ecg and clinical laboratory tests * qtcb interval of \> 430 (mean qtcb of two measurements \> 430msec) * abnormal pulse rate measurement (\ 90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min. * abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows: * systolic blood pressure \ 160 mmhg * diastolic blood pressure \ 90 mmhg * positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of \> 20 mmhg in systolic blood pressure after 2 min standing and an increase in pulse rate of ≥ 20 bpm * regular use of any prescribed or otc drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the research unit or any use of such drugs in the 2 weeks prior to first admission to the research unit

Keywords: pharmacokinetics mirabegron phase 1
the effects of ilioinguinal nerve block on chronic pain in patients in inguinal hernia with spinal anesthesia

Conditions: Ilioinguinal Nerve Block

Summary: regional anesthesia is a popular anesthetic method in patients who will undergo an inguinal hernia operation. researchers known that pain in the operating area is a complaint that impairs the quality of life for patients in the long term after the operation. in addition to regional anesthesia, has planned to investigate the effects of applying another drug near the surgery area on pain that may develop in the long term.

post-operative chronic pain can be defined as the neuropathic-characterized pain persisting at least 3 months after the surgery despite healing of the operation area. however, it is still uncertain if the underlying physio-pathologic mechanism is due to intraoperative direct nerve injury or it is resulting from indirect nerve injury caused by inflammatory mesh. post-operative chronic pain restricts the daily activities, causes anxiety and depression, increases use of analgesics and imposes a serious economic burden by increased use of health services and medical treatment. for this reason, today post-operative chronic pain is considered as an important complication of surgery. researchers can list the risk factors of pain development as; age, weight, preoperative and postoperative pain, surgical method, recurrence, anesthesia method. various oral non-steroid and/or opioid agents have been used in chronic pain treatment but nowadays interest in regional anesthesia approaches is increasing due to increased systemic side effects. aim in this study is to evaluate the effects of postoperative ilioinguinal block implementation on chronic pain in patients who will undergo inguinal hernia operation with spinal anesthesia.

Eligibility criteria:
inclusion criteria: * asa i-iii * age 18-65 * inguinal hernia operation with spinal anesthesia * patients who agreed to participate in the study exclusion criteria: * mental retards and communication disorder * infection at the injection site * patient with a clotting disorder * local anesthetic allergy

Keywords: inguinal hernia ilioinguinal nerve block chronic pain
study evaluating nelotanserin for treatment of visual hallucinations in subjects with lewy body dementia

Conditions: Lewy Body Dementia; Visual Hallucinations

Summary: this study seeks to evaluate safety and efficacy of nelotanserin for the treatment of visual hallucinations in subjects with lewy body dementia.

this is a double-blind, randomized, placebo-controlled, cross-over study in subjects with lewy body dementia who experience frequent visual hallucinations. subjects who meet the randomization criteria enter the double-blind treatment period. each subject will be randomized 1:1 to one of the 2 treatment sequences: nelotanserin in the first treatment period followed by placebo in the second treatment period, or placebo in the first treatment period followed by nelotanserin in the second treatment period.

Eligibility criteria:
inclusion criteria: * adult subjects at least 50 years of age, with a diagnosis of lbd based on dsm-5 diagnostic criteria or diagnosis of parkinson's disease dementia (pdd) based on dsm-5 diagnostic criteria; * presence of frequent visual hallucinations * mini mental state examination score ≥ 18 exclusion criteria: * subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder * subjects' psychotic symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse * subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Keywords: lewy body dementia dementia with lewy bodies parkinson's disease dementia lewy bodies visual hallucinations
association of hypertensive disorder of pregnancy with sleep-disordered breathing.

Conditions: Hypertensive Disorder of Pregnancy; Sleep-disordered Breathing

Summary: this study aims to assess the prevalence of sleep disorder breathing in pregnant women with a singleton gestation who develop hypertensive disorder of pregnancy (hdp) compared to women without hdp, when matched for gestational age and body mass index.

sleeping disorder breathing is not only underdiagnosed in the general population, but more specifically in pregnant women. some recent research has found an association between sleep disorder breathing and preeclampsia. both conditions have shown to be associated with worse pregnancy outcomes. therefore, more research is needed to find the strength of these associations. by gathering more information, this provides investigators with an opportunity to see if there is a way to slow the progression of complications in preeclampsia through the management of sleep-disordered breathing. preeclampsia continues to be one of the top reasons for maternal mortality in the u.s. and this percentage continues to grow each year. through the study, investigators hope to bring awareness of the comorbidity and how its similar pathogenesis can potential exacerbate complications in pregnant women.

Eligibility criteria:
inclusion criteria: * 1. subject who is capable of consenting in english * 2.women with a diagnosis of a hypertensive disorder of pregnancy * 3.greater than 20 weeks pregnant * 4.singleton fetus * 5.inpatient exclusion criteria: * 1.with acute respiratory distress, including asthma * 2.with micrognathia and other severe craniofacial abnormalities * 3.active heart failure * 4.sepsis * 5.subjects in labor.

Keywords: hypertensive disorder of pregnancy sleep-disordered breathing hdp sdb
the efficacy and safety of fluzoparib plus irinotecan as second-line treatment in patients with homologous recombination deficiency (hrd) metastatic colorectal cancer.

Conditions: Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer

Summary: preclinical data support the investigation of parp inhibitors in other neoplasms exhibiting homologous recombination deficiency (hrd) as monotherapy as well as in combination with chemotherapy. however，in colorectal cancer (crc), the role of hrd alterations is mostly unknown. this study aims to explore the the efficacy and safety of fluzoparib combined with irinotecan in the second-line treatment of hrd alterations metastatic colorectal cancer.

study protocol for an open-label, single-arm, phase ii study of combination of fluzoparib and rinotecan as the second-line treatment for patients with hrd alterations metastatic colorectal cancer (mcrc). patients will receive fluzoparib combined with irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks.

Eligibility criteria:
inclusion criteria: * 18-75 years； * histological or cytological confirmed metastatic colorectal cancer; * hrd alterations（inclued brca1/2、atm、cdk12、palb2、check2、rad51c、rad51d etc.）； * intolerability toxicity occurs 8 weeks within first-line therapy; * ecog ps 0-1; * adequate hepatic, renal, heart, and hematologic functions; * negative serum pregnancy test at screening for women of childbearing potential; * informed consent was signed before the study began. exclusion criteria: * prior treatment with parpi drugs； * symptomatic brain or meningeal metastases； * patients have received local radiotherapy within 1 month prior to treatment; * patients who had active bleeding or coagulopathy before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment; * women who are pregnant (with a positive pregnancy test before medication) or breastfeeding; * expected survival \<3 months; * received other investigational drugs within 4 weeks prior to treatment; * patients who had active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response; * allergy to the study drug or any of its excipients;

Keywords: fluzoparib plus irinotecan homologous recombination deficiency (hrd) alterations
effects of innovative aerobic exercise training in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the main objective of this study is to compare the effectiveness of two different exercise interventions in a patient-centered, home-based exercise program for improving cardiorespiratory-fitness in people with cystic fibrosis (cf). we hypothesize cystic fibrosis patients participating in a high intensity interval training (hiit) group will experience greater improvements in cardiorespiratory-fitness than those in a moderate continuous training (mct) group. further, we plan to investigate the efficacy of the comparators on patient-centered outcomes.

this study is a randomized control trial that compares mct to hiit using a patient-centered and home-based delivery model with cf care centers in the united states. participants will be randomly allocated to either an mct or hiit arm. both the mct and hiit interventions are accepted forms of prescribed exercise in clinical practice. the interventions will be delivered with a telehealth platform using internet (hipaa-compliant video), phone, and email/text support. all study sites will receive initial and on-going training and program facilitation to assure consistency of delivering the intervention. all participants across both arms visit their respective cf clinics on a regular basis for routine cf care. thus, our research team will be able to coordinate all testing/assessment visits, including long-term (18-month timepoint), with participants throughout the study. the primary and secondary outcomes include important patient-centered outcomes as selected by our study's cf patient and stakeholder advisory board.

Eligibility criteria:
inclusion criteria: * diagnosed with cystic fibrosis * prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (trikafta) * 18 years and older exclusion criteria: * 17 years of age or less * not eligible for ivacaftor-tezacaftor-elexacaftor (trikafta) * inability to exercise * pregnancy * status post lung transplantation * already participating in more than 150 minutes of aerobic exercise per week