Kornimate/medical-research-clean huggingface dataset:
define afib (atrial fibrillation)

Conditions: Atrial Fibrillation

Summary: define afib is a prospective, observational, post-market clinical study administered to patients via the medtronic discovery app platform. this study will enroll approximately 5,000 patients in the united states who have a reveal linq or linq ii icm (or future market-released linq devices) and an apple® iphone® with ios version 13 or higher. interested participants will be screened through the medtronic discovery app and those eligible will complete an app-based informed consent. participants will receive health-focused and quality of life surveys at variable timepoints. define afib will measure healthcare interactions using administered surveys to identify said interactions. the medtronic discovery app will provide participants with a summary of their icm data. participants will be followed up to 5 years or to the end of their icm service life.


Eligibility criteria:
inclusion criteria * patients with a linq icm who have a self-reported history of af and who have received an icm for the following device-logged indications, categorized into the following discrete groups: * af management: af management and post-ablation management indications * suspected af: suspected af and palpitations indications * stroke: cryptogenic stroke indication * individual access and ability to use an apple iphone® compatible with medtronic's research app (ios® v. 13.x or higher) * patient is willing and able to comply with the protocol, including carelink transmissions (requires adequate connectivity), remotely administered instructions, and remote survey participation * patient is 22 years of age or older * located in the united states, with carelink managed through servers located in united states (50 states or district of columbia) * valid email address from self-report at enrollment * patient must be able to read and write in english exclusion criteria patients with \> 24 months elapsed time from recorded linq device implant or \> 48 months elapsed from recorded linq ii implant date
comparative study between combined vaginal misoprostol

Conditions: Missed Abortion

Summary: "comparative study between combined vaginal misoprostol with isosorbide-5-mononitrate

"comparative study between combined vaginal misoprostol with isosorbide-5-mononitrate versus misoprostol alone for induction of the first trimester missed abortion a randomized clinical trial"

Eligibility criteria:
inclusion criteria: * - maternal age 18 - 35 years. * gestational age first trimester of pregnancy (between 5-13 weeks). * missed abortion confirmed by ultrasound. * singleton pregnancy. * normal uterus and cervix on clinical examination. * cervix is not dilated. * no vaginal bleeding. exclusion criteria:- evidences suggesting start of spontaneous abortion and previous trial to induce abortion. * presence of uterine contraction or bleeding, * multi-fetal pregnancy. * suspicion of septic abortion. * history of previous cervical surgery or manipulation. ex: cervical tear , cervical cauterization . * uterine anomaly. * presence of iud( intrauterine device) in situ * underlying medical diseases.ex:diabetes mellitus,hypertension * history of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate * those unwilling to participate in the trial * higher order cesarean section(more than three
bianca-sc: a study of the efficacy, safety, and tolerability of blisibimod in addition to methotrexate during induction of remission in subjects with anca-associated small vessel vasculitis

Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Summary: the purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in anca-associated small vessel vasculitis.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older (male or female). 2. granulomatosis with polyangiitis (gpa, or wegener's granulomatosis) or microscopic polyangiitis (mpa) according to the definitions of the american college of rheumatology and chapel hill consensus conference. 3. active gpa or mpa disease at screening. 4. positive for either pr3-anca or mpo-anca at screening. 5. subject willing to initiate corticosteroids and methotrexate (mtx) if not already on corticosteroids and/or mtx at baseline. 6. clinical intention to prescribe mtx therapy for treatment of gpa or mpa. exclusion criteria: 1. diagnosed with churg strauss syndrome. 2. severe gpa or mpa disease that would conventionally be treated with cyclophosphamide. 3. nursing or pregnant. 4. active systemic infection or deep-space infection. 5. active hepatitis b, active hepatitis c or a documented history of hiv, hepatitis b, or hepatitis c. 6. liver disease. 7. history of documented anti-glomerular basement membrane (gbm) disease. 8. malignancy within the past 5 years. 9. history of active tuberculosis (tb) or history of tb infection. 10. anemia, neutropenia, or thrombocytopenia. 11. serum creatinine level greater than 2.5 mg/dl. 12. prior administration of a b-cell modulating therapy other than rituximab. 13. subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study. 14. history of congenital immunodeficiency.

Keywords: granulomatosis with polyangiitis microscopic polyangiitis anti-neutrophil cytoplasmic antibodies anca-associated vasculitis wegener granulomatosis
treatment of acute pth with a cgrp receptor mab in military service members and civilians with mtbi

Conditions: Posttraumatic Headache; Mild Traumatic Brain Injury

Summary: this study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (pth) in military service members and civilians with mild traumatic brain injury (mtbi).

headache is recognized as one of the most common and disabling symptoms following head trauma. this study is designed to assess a calcitonin gene-related peptide (cgrp) monoclonal antibody (erenumab) for the preventive treatment of pth based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cgrp. this study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of pth in military service members and civilians with mtbi at military treatment facilities across the united states.

Eligibility criteria:
inclusion criteria: * male or female ≥18 and ≤50 years of age * mtbi from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days * pth has occurred within the prior 7 days * able to provide informed consent * likely to stay in the same geographical area for the duration of study * has a personal health care provider for standard of care pth and tbi, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider exclusion criteria: * sustained a moderate or severe tbi, rather than mtbi, indicated with at least 1 of the following associated with head injury: 1. abnormal structural imaging 2. loss of consciousness for \>30 minutes 3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day * participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
ectoin lozenges (eht02) in the treatment of oropharyngeal allergic symptoms

Conditions: Allergy

Summary: the goal of this multicentric, prospective, randomised, controlled study (§23b german act on medical devices (mpg)) is to investigate the efficacy of ectoin lozenges (eht02) in treatment and prevention of oropharyngeal allergic symptoms.

the immune system of humans can show an overreaction to proteins from the environment (allergic reaction). triggers of these allergic reactions may be e.g. pollen, dust mites, mold or animal hair. common allergic symptoms include itchy, stuffy, runny nose, sneezing, itchy and watery eyes and respiratory complaints. allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease. an example of such immunotherapies is the sublingual immunotherapy (slit). during slit, side effects may occur such as local oropharyngeal reactions, e.g. manifesting as itching, swelling or irritation. the current study aims to investigate the efficacy of ectoin lozenges (eht02) in patients suffering from oropharyngeal allergic symptoms. the symptoms are induced by slit. patients are dedicated to one of three groups: a) preventive application of ectoin lozenges before slit-initiation, b) therapeutic application of ectoin lozenges after slit-initiation or c) control: slit-initiation without application of ectoin lozenges. the symptoms itching, swelling and irritation of mouth, lips and throat will be documented by the patients once 30 minutes after slit-initiation.

Eligibility criteria:
inclusion criteria: * initiation of a slit * minimum age of 18 years * written consent of the patient exclusion criteria: * surgical procedures in the mouth and throat region prior to the study * patients with known intolerance to one of the substances used * pregnant or breast-feeding women
a study of tirzepatide (ly3298176) in participants with heart failure with preserved ejection fraction (hfpef) and obesity: the summit trial

Conditions: Obesity; Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary: the main purpose of this study is to assess the efficacy and safety of tirzepatide (ly3298176) in participants with heart failure with preserved ejection fraction and obesity.

the study will continue until approximately 52 weeks after the last participant is randomized. the maximum duration of an individual's participation is estimated to be \~120 weeks and will depend on duration of study enrollment.

Eligibility criteria:
inclusion criteria: * have a diagnosis of stable heart failure (nyha class ii-iv) and left ventricular ejection fraction (lvef) ≥50% * elevated nt-probnp (n-terminal pro b-type natriuretic peptide) \> 200 pg/ml for participants without atrial fibrillation (af), or \>600 picogram/milliliter (pg/ml) for participants with af, structural heart disease (left atrial enlargement) or elevated left ventricular filling pressure * estimated glomerular filtration rate (egfr) \<70 milliliter (ml)/minute (min)/1.73m² at screening, or hf decompensation within 12 months of screening, * stable dose of heart failure medications within 4 weeks of screening * body mass index (bmi) ≥30 kilograms per meter squared (kg/m²) * 6mwd 100-425m * kccq css ≤80 exclusion criteria: * have had a major cardiovascular event within the last 90 days of screening * have had acute decompensated heart failure within 4 weeks of screening * have non cardiac causes of functional impairment such as pulmonary arterial hypertension (pah), severe chronic obstructive pulmonary disease (copd), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions * presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease * hba1c ≥9.5% or uncontrolled diabetes * history of proliferative diabetic retinopathy or diabetic maculopathy * have a history of pancreatitis * egfr \<15 ml/min/1.73 m² or requiring dialysis at screening

Keywords: heart failure with preserved ejection fraction (hfpef)
percent weight change in the medical supplement group of early breast cancer

Conditions: Early Stage Breast Cancer

Summary: the goal of this rct is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard ac regimen). the main question is • the change of weight (%) before and after complete treatment of breast cancer therapy. participants will be randomized into 2 group * intervention group - receive medical supplement daily during chemotherapy treatment. * control group - nutritional advise during chemotherapy treatment.

1. the rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life. 2. primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in rajavithi hospital. secondary endpoints are nutritional status (pg-sga), quality of life. 3. sample size formula based on bernard r. fundamentals of biostatistics. 5th ed. duxbery: thomson learning; 2000. enrollment of 40 patients. 4. randomization into 2 groups. intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. control arm : nutritional advise only. duration of treatment is 12 weeks 5. enrollment and data monitoring is assessed by the staffs of oncology department in rajavithi hospital and the data will be recorded in computer based information system. 6. data assessment on week 0,6,12 during chemotherapy treatment. 7. data analyzed by descriptive statistics to characterize patients at entry. we did the efficacy analyses with intention to treat population 8. we did analyses with r version 3.3.0.

Eligibility criteria:
inclusion criteria: * histopathological confirmed diagnosis of breast cancer * breast cancer stage i-iii * recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at rajavithi hospital * lvef \>= 60% - ecog score 0-1 exclusion criteria: * no indication for chemotherapy * contraindication for chemotherapy * breast cancer stage iv * diabetic mellitus who requires insulin injection * bmi \>= 30 kg/m2 or \<= 16 kg/m2 * previously known other malignancies * second primary cancer * previously received chemotherapy or radiotherapy * severe malnutrition with administration of tpn is indicated * pregnancy or lactation * ckd stage 4-5

Keywords: medical supplement weight change in early breast cancer treatment
waterproof casting versus standard casting for short leg walking casts

Conditions: Ankle Fractures; Foot Fracture; Ankle Sprains; Foot Sprain; Toe-walking; Tendonitis of Foot; Apophysitis; Juvenile

Summary: the purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

this study aims to prospectively examine a group of pediatric patients that receive either a waterproof or non-waterproof short leg cast. from this, we will be able to determine if there are any significant differences between the two groups. if waterproof short leg casts do not cause increased skin breakdown or lead to increases in cast complications and unintended clinic visits, then we can more confidently apply them to pediatric patients, particularly in the summer months when children are more likely to swim. on application of a waterproof, short leg walking cast, a questionnaire will be distributed to the patient/family to track how many times the cast gets wet. during the application of the cast, materials will be tracked for cost analysis. the subject will return between 3 and 7 weeks for cast removal. on cast removal, the following questionnaires will be completed: cast condition, skin condition, overall patient/family satisfaction, and promis pediatric lower extremity function - mobility. questionnaires will take approximately 5 - 10 minutes to complete. the parent survey regarding how many times the cast got wet will be returned (if applicable). waterproof and non-waterproof groups will be compared in the basis of cast condition, promis lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. outside of the randomization itself, all standard of care procedures or normal practice activities will occur. each participant will undergo cast application as recommended per standard of care. study participation does not involve more than minimal risk since everything outside of the randomization is standard of care. waterproof and non-waterproof groups will be compared in the basis of cast condition, promis lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. a chi-square test will be used to analyze the data.

Eligibility criteria:
inclusion criteria: • being placed in a short leg walking cast for one of the diagnoses listed below: * ankle fracture * foot fracture * ankle sprain * foot sprain * toe-walking * tendonitis * apophysitis exclusion criteria: * patients with wounds to the foot or ankle prior to cast placement * patients with cognitive dysfunction
comparison of gd-eob-dtpa-enhanced mri and contrast-enhanced ultrasound for measuring tumor size of solitary hepatocellular carcinoma ≤ 5cm:a retrospective study

Conditions: HCC - Hepatocellular Carcinoma

Summary: knowing the tumor size before operation is of great significance to the choice of treatment methods of surgeons and the prognosis of patients. in this study, two commonly used imaging methods( ce-mri/ceus) were selected to measure and compare the tumor size before operation, in order to determine which measurement method is more accurate.

a total of 194 patients who met the inclusion criteria from january 2019 through may 2024 were included. taken pathological results as the gold standard, paired t-test and bland-altman analisis were conducted to assess the correlation and mean absolute error between the measured tumor sizes obtained from ce-mri/ceus and pathological results.

Eligibility criteria:
inclusion criteria: 1. had no anti-hcc therapy before imaging examinations. 2. at least had one examination of gd-eob-dtpa-enhanced mri and ceus 2 weeks before surgery and confirmed as one single hcc. 3. if the patient had both imaging tests, the time interval between two examinations was less than 1 weeks. 4. both radiological and pathological results recorded the maximum tumor diameter. exclusion criteria: 1. had anti-hcc therapy before imaging examinations. 2. had no examination of gd-eob-dtpa-enhanced mri or ceus 2 weeks before surgery . 3. had no radiological or pathological results recorded the maximum tumor diameter.
velphoro and impact on the oral cavity and gut microbiome

Conditions: Hyperphosphatemia

Summary: this pilot study will be carried out to determine if the regular intake of iron-based velphoro® by hyperphosphatemia patients influences the microbiome in the oral cavity and/or the gut.

the aim of this study is to investigate potential changes in the microbiome of the oral cavity and/or gut in patients with hyperphosphatemia following velphoro® intake for one month. the principal intention of this study is to assess consequences of velphoro® medication beyond phosphate control. adherence to the drug might be compromised by e.g. staining of teeth and biofilm after chewing the product more than recommended. most likely this is a cosmetic problem only and easy to solve by optimizing oral hygiene. the increased level of iron may have an effect on the gut microbiome which could lead to mild diarrhoea. however, the present study will assess, whether the microbiome both oral and gut changes significantly due to some iron bio-availability, although this is expected to be low with sucroferric oxyhydroxide. the ultimate goal is to improve patient adherence to the drug and to resolve potential safety concerns.

Eligibility criteria:
inclusion criteria: * suffering from hyperphosphatemia * current treatment with a stable dose of a non-iron containing phosphate binder, * no or only parenteral iron application * age of ≥ 18 years * written informed consent prior to study participation * the subject is willing and able to follow the procedures outlined in the protocol control group: * normal renal function * no hyperphosphatemia * age- and sex-matched and oral disease status-matched (dental caries and periodontal disease) in comparison to the hyperphosphatemia group * written informed consent prior to study participation * the subject is willing and able to follow the procedures outlined in the protocol exclusion criteria: * age less than 18 years * currently on oral iron application * antibiotic treatment within the last two months * severe medical events within the last three months * planned surgery for the duration of the sampling * acute/chronic gastrointestinal infections * smokers * oral candidiasis * oral cancer * pregnant and lactating females * haemochromatosis history * committed to an institution by legal or regulatory order * participation in a parallel interventional clinical trial * receipt of an investigational drug within 30 days prior to inclusion into this study * the subject is mentally or legally incapacitated only for the patient group: * never got any phosphate binder * allergy to velphoro® * celiac disease or any other chronic inflammatory bowel disease * previous major surgery in the gastrointestinal tract

Keywords: microbiome
quality of analgesia after interscalene block after arthroscopic shoulder surgery

Conditions: Injury of Shoulder Region

Summary: shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.

the interscalene brachial plexus block (isbpb) is a common analgesic technique for procedures of the shoulder and upper arm. moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.this study is designed to compare the level and duration of pain control of exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for isbpb.

Eligibility criteria:
inclusion criteria: * dutch or english speaking adults * 18 years or older asa i-iii physical class * scheduled for elective arthroscopic shoulder surgery exclusion criteria: * history of allergy to a local anesthetic * baseline neurological deficit * medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff * recent history (\< 3 months) of drug or alcohol abuse * concomitant opioid therapy * preexisting coagulation disorder * infection at the injection site * pregnancy
safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (t2dm) on background therapy with glimepiride with or without metformin

Conditions: Diabetes Mellitus, Type II

Summary: this study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (t2dm) who are receiving background therapy of glimepiride with or without metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, diagnosed at least 3 months prior to screening (visit 1) * bmi 20 to 48 kg/m2, inclusive * hba1c 7.0% - 10.0%, inclusive * age 18 to 85 years, inclusive exclusion criteria: * currently on 3 or more oral antidiabetic drugs or insulin. * type 1 diabetes mellitus