Kornimate/medical-research-clean huggingface dataset:
cardiac assessment by pv loop in ipah and scleroderma pah

Conditions: Scleroderma; Pulmonary Artery Hypertension

Summary: this observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated pah) and a weak heart muscle (heart failure). the study will also help the investigators understand why people with pah from an unknown cause (called idiopathic pah, or ipah) can also develop a weakened heart muscle. the response of the right side of the heart or right ventricle (rv) to standard pah therapy in scleroderma-associated pah and in ipah will be assessed. blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. people with scleroderma-associated pah or idiopathic cause (ipah) who need a right heart catheterization may join this study.

patients with scleroderma associated pulmonary hypertension (with or without interstitial lung disease) have a worse prognosis compared to patients with idiopathic pulmonary arterial hypertension (ipah). the investigators have discovered through a previous protocol that patients with scleroderma associated pulmonary hypertension (ssc-pah) have intrinsic right ventricular (rv) contractile dysfunction compared with patients with idiopathic pulmonary hypertension (ipah) despite similar afterload imposed by the pulmonary vasculature. patients with scleroderma or presumed/known ipah who are clinically referred for right heart catheterization (rhc) will undergo, in addition to a clinically indicated rhc, state-of-the-art pressure-volume (p/v) loop assessment and rv biopsy for research purposes. the investigators will also do a standard pathologic assessment of the rv tissue (h\&e, special staining, electron microscopy), microvascular density measurements using immunohistochemistry techniques and isolated skinned myocyte experiments. additional experiments will include proteomics, genomics/genetics, and rv protein and microrna expression. the investigators will compare these findings in both groups (ipah and ssc-pah), before and after standard treatment for 6 months, in order to fully understand the differences in how the rv adapts to pressure overload and reasons for impaired rv function in ssc-pah as well as identifying potential therapeutic targets.

Eligibility criteria:
inclusion criteria: * patients 18 years or older with clinically diagnosed scleroderma or presumed/known idiopathic pulmonary hypertension. exclusion criteria: * patients found to have secondary pulmonary hypertension (ph due to left heart failure) on clinical rhc. * hemodynamically unstable patients (systolic blood pressure \< 90mmhg, vasopressor requirement). * patients whom are unable to give consent for themselves. * patients with rv clot or septal aneurysm will be excluded. * in order to undergo the clinical right heart catheterization procedures, pregnancy testing (urine or serum) is standard of care. * pregnancy
furcation treatment with l-prf and apdt

Conditions: Furcation Defects

Summary: to treat grade ii periodontally diseased furcation areas leukocyte-platelet rich fibrin (l-prf) combined with antimicrobial photo-dynamic therapy (a-pdt) was used.

randomized, triple-blinded study (patient, clinician and biostatistician). twenty-four patients with grade ii furcation involvement were recruited in this study. control group only received l-prf, while study group used a combination of l-prf and apdt attachment level, pocket depth, horizontal component and gingival recession, also radiographic bone depth, width, height and volume were were recorded at baseline and postoperatively after 6 months

Eligibility criteria:
inclusion criteria: * grade ii furcation involvement * age range 18- 50 years * 3 mm or more vertical probing depth exclusion criteria: * systemic disease * abnormal clotting and bleeding * smokers, * root caries or restoration * grade ii mobility * periapical lesions

Keywords: platelet rich fibrin photodynamic therapy
diagnostic accuracy of bedside ultrasound in suspected acute diverticulitis

Conditions: Acute Diverticulitis; Abdominal Pain

Summary: colonic diverticulitis is a common clinical condition in patients presenting to the emergency department (ed) with abdominal pain. the diagnosis and staging of patients with suspected acute diverticulitis is often made by ct imaging with intravenous contrast, which involves radiation exposure, is expensive and has contraindications. the aim of this study is to evaluate the diagnostic accuracy and role of bedside abdominal us for the diagnosis of acute diverticulitis

colonic diverticulitis is a common clinical condition; about 20% of patients with colonic diverticulosis experience abdominal symptoms and, eventually, complications such as episodes of diverticulitis or bleeding. the distinction between patients with uncomplicated or complicated diverticulitis affects the clinical management: medical therapy for the first, interventional therapy for the latter. ct imaging with intravenous contrast has become the gold standard in the diagnosis and staging of patients with suspected acute diverticulitis but, unfortunately, ct involves radiation exposure, is expensive and has contraindications. ultrasound (us) is a real-time dynamic examination with wide availability and easy accessibility and may be useful in diagnosing and managing critically ill patients who cannot be moved to ct. in a recent meta-analysis, us exam performed by radiologists showed a pooled sensitivity of 90% (vs 95% for ct, p = 0.86) and a specificity of 90% (vs 96% for ct, p = 0.04). us is increasingly used at bedside to rapidly assess patients presenting to the emergency department. no previous studies have investigated the diagnostic accuracy of abdominal us performed by physician at bedside as an extension of physical examination. this study evaluates the diagnostic accuracy of bedside abdominal us.

Eligibility criteria:
inclusion criteria: * informed consent obtained * patients with abdominal pain presenting to the emergency department with a suspicon of diverticular disease, in whom the tutor physician orders an imaging study (abdominal ct or abdominal us performed by the radiologist) exclusion criteria: * no ultrasonographer physician who can perform bedside abdominal us is present * the patient does not undergo imaging study * clinical conditions of the patient are particularly severe, preventing an adequate enrollment

Keywords: ultrasound diagnosis abdominal ultrasound emergency department
the role of music in enhancing attention during visual field exams for pediatric glaucoma patients

Conditions: Glaucoma

Summary: the goal of the study is to see if the use of music improves attention during visual field exams for pediatric glaucoma patients.

this study aims to determine if music can be used as an intervention to improve attention and quality of results in pediatric glaucoma patients taking visual field exams. the investigators also want to determine the most effective method and type of music by which it can be implemented into the test to improve patient experience and results. if there is an improvement, it will benefit the patient and the provider in administering the test and the utility of the results. to that end, patients between the ages of 8-17 with glaucoma or glaucoma suspect diagnosis will be recruited from the clinic with consent from their parents and assent from the patient to participate in the study. they will come in on two scheduled dates after being randomized to either a control or experimental group. on the first date, the participants assigned to the control group will complete the visual field exams (vfe) without music, and the experimental group will listen to music and complete a pre and posttest survey regarding test taking experience. on the second date, the groups will switch and the participant will complete the other part of the study. results will then be analyzed and compared between the groups and previous results.

Eligibility criteria:
inclusion criteria: * glaucoma or glaucoma suspect exclusion criteria: * post operative patient * non english speaking

Keywords: pediatric glaucoma music research ophthalmology
point of care evaluation of fibrinolysis in sepsis

Conditions: Fibrinolytic Defect; Sepsis; Critical Illness

Summary: impaired fibrinolysis in septic patients is associated with worse outcome. the present study investigates fibrinolysis shutdown in septic patients, defined as prolonged clotpro® tpa lysis time at 30 minutes. the tpa lysis time reference range is established in a cohort of healthy volunteers.


Eligibility criteria:
inclusion criteria: * age \> 18 years * sepsis or septic shock * vasopressors required to maintain a map ≥ 65 mmhg despite adequate fluid resuscitation exclusion criteria: * coagulation disorders * ecmo therapy * use of oral anticoagulant drugs
study of shr-8068 combined with adebrelimab and bevacizumab in the treatment of advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: to evaluate the tolerability and safety of shr-8068 in combination with adebrelimab and bevacizumab in subjects with advanced hcc; to evaluate the efficacy of shr-8068 in combination with adebrelimab and bevacizumab in subjects with advanced hcc.


Eligibility criteria:
inclusion criteria: 1. age 18\~75 years old, both male and female; 2. stage 1: pathologically diagnosed, incurable advanced hcc subjects who have failed standard treatment or were unwilling to accept standard treatment; 3. stage 2: pathologically diagnosed, incurable advanced hcc subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment; 4. at least one measurable lesion based on recist v1.1 criteria; 5. barcelona clinic liver cancer: stage b or c; 6. ecog ps score: 0-1 points; 7. child-pugh score: ≤ 7; 8. expected survival period ≥ 3 months; 9. adequate organ function. exclusion criteria: 1. fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; 2. patients with any active, known or suspected autoimmune disorder; 3. systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose; 4. with known severe allergic reactions to any other monoclonal antibodies; 5. patients with known cns metastasis or hepatic encephalopathy; 6. patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation; 7. patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose; 8. patients with other malignancies currently or within the past 5 years; 9. patients with hypertension which cannot be well controlled by antihypertensives; 10. uncontrolled cardiac diseases or symptoms; 11. patients with other potential factors that may affect the study results.
comparison of cle in vivo diagnosis and ex vivo examination against surgical histopathology of cpl

Conditions: Cystic Pancreatic Disorders

Summary: comparison of confocal laser endomicroscopic in vivo diagnosis and ex vivo examination against surgical histopathology of cystic pancreatic lesions.

the primary objective of the study is to assess the ability of ncle (aq-flex) to accurately diagnose the type of cpl by comparing in vivo and ex vivo cle patterns to final histopathology of surgically resected cpls. the primary endpoints are whether or not the cle diagnosis correlates with final diagnosis (yes vs. no).

Eligibility criteria:
inclusion criteria: for in vivo ncle (needle-based confocal laser endomicroscopy) (part 1): * patient age 18 years and older * all patients referred for eus-fna (endoscopic ultrasound - fine needle aspiration) of accessible cpl (cystic pancreatic lesion) * the minimum size of the cyst should be ≥ 1.5 cm as determined by prior cross-sectional imaging studies. for ex vivo pcle (probe-based confocal laser endomicroscopy) (part 2): * all patients must satisfy inclusive criteria for in vivo ncle. * all patients should have completed eus-guided ncle. * all patients should have a cpl lesion referred for surgical removal based on recommended international consensus guidelines1 and inter-departmental consensus pancreatic tumor board meeting (departments of surgical oncology, radiology, pathology and gastroenterology). * patient participated and completed in vivo ncle (part 1) exclusion criteria: * unable to obtain informed consent * unable to tolerate the procedure * women with known pregnancy at time of procedure * patient age less than 18 years * bleeding diathesis * lesion not accessible by eus guided fna * allergy to fluorescein.
a trial investigating the pharmacokinetic and pharmacodynamic properties of fiasp when administered as a bolus in a continuous subcutaneous infusion regimen in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of fiasp (faster-acting insulin aspart) and insulin aspart (novorapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (csii).


Eligibility criteria:
inclusion criteria: * male or female aged 18-64 years (both inclusive) at the time of signing informed consent * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index (bmi) 18.5-28.0 kg/m\^2 (both inclusive) * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for at least 12 months exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
special use-result surveillance of unasyn-s (kit) for intravenous use - a surveillance on high-dose (>6 g daily) administration -

Conditions: Pneumonia; Lung Abscess; Peritonitis

Summary: the purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of unasyn-s and unasyn-s kit for intravenous use (unasyn). 1. adverse drug reaction(s) that cannot be expected from precautions (unexpected adverse drug reaction) 2. incidence status of adverse drug reactions 3. factors that may affect the safety and effectiveness

implemented as a special investigation by a central registration system. secondary data collection. safety and effectiveness of unasyn-s under japanese medical practice.

Eligibility criteria:
inclusion criteria: * patients with the following disease who received high doses of unasyn (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) pneumonia, 2) lung abscess, 3) peritonitis * patients aged 15 years or more exclusion criteria: * patients with the following disease who received high doses of unasyn (less than 6 g per day) from the first dosing date or the second dosing date. 1) pneumonia, 2) lung abscess, 3) peritonitis * patients aged less than 15 years.

Keywords: unasyn-s high dose
supported treadmill ambulation training (stat) for patients diagnosed with amyotrophic lateral aclerosis

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Lou Gehrig's Disease

Summary: the purpose of this study is to find out if supervised exercise training using a treadmill with partial weight support is safe and has an impact on gait and function of persons with amyotrophic lateral sclerosis.

twenty als patients who are independent in their transfer with assistive devise such as walker, cane, or afo will be offered the opportunity to participate in this study. 20 subjects will be enrolled at carolinas als/neuromuscular center at the carolinas healthcare system. eligible subjects will return for 26 sessions, each lasting between 1-2 hours. at session 1 (4 weeks pre-treatment), assessments of muscle strength, spasticity, gait, and balance will be performed, which will take between 30-60 minutes. at sessions 2-25, patients will do supported treadmill ambulation training at a very low speed 3 times a week for 6 weeks under the supervision of the physical therapist. each session will have 30 minutes of direct ambulation with the suspension system and treadmill over a 60 minute period of time. additionally, at sessions 13 and 26 (4 and 8 weeks post-treatment), the assessments of muscle strength, spasticity, gait, and balance will be repeated. needle emg to assess denervation potential will be performed at base line and at the conclusion of the study. the study will last a total of 26 weeks for each patient.

Eligibility criteria:
inclusion criteria: * clinically probable or definite diagnosis of als/mnd * able to stand independently and ambulate for six minutes with their assistive devices * able to complete the 25 foot walk in less than 1 minute * vital capacity of over 65% predicted * 25 to 75 years of age * not a pregnant woman * able to provide informed consent and to comply with training and assessment procedures exclusion criteria: * unstable angina or severe left main coronary disease * end-stage congestive heart failure * severe valvular heart disease * malignant or unstable arrhythmias * elevated resting blood pressure (systolic, 200mmhg; diastolic, 110mmhg) * large or expanding aortic aneurysm * known cerebral aneurysm or recent intracranial bleed * uncontrolled or end-stage systemic disease * acute retinal hemorrhage or recent ophthalmologic surgery * acute or unstable musculoskeletal injury

Keywords: exercise for amyotrophic lateral sclerosis
randomized controlled multi-center short course treatment for rifampicin resistant tuberculosis

Conditions: Tuberculosis

Summary: this study is a randomized, controlled, multi-center clinical study. the main purpose of this study was to study the efficacy and safety data of total oral short-term therapy as an alternative to injection in the treatment of newly diagnosed rr-tb patients.

a group: 4-6 inh emb pza pto am cfz mfx / 5 emb pza cfz mfx b group: 4-6 inh emb pza pto lzd cfz mfx / 5 emb pza cfz mfx c group: 4-6 bdq lzd mfx cs cfz / 5mfx cs cfz (inh: isoniazid, emb: ethambutol, pza: pyrazinamide, pto: prothionamide, am: amikacin, cfz: clofazimine, mfx: moxifloxacin, lzd: linezolid, bdq: bedaquiline, cs: cycloserine) a group is the control group which includes injectable drugs (am). b group and c group are the experimental groups which are total oral short-term therapy.

Eligibility criteria:
inclusion criteria: * signed informed consent and accepted follow-up; * the age is between 18 and 65 years old, both male and female, including inpatients and outpatients; * no use of anti tuberculosis drugs, or use of anti tuberculosis drugs less than 1 month; * the results of molecular biology test confirmed rifampicin resistance or mdr-tb patients; * chest ct examination confirmed pulmonary tuberculosis, pulmonary lesions, or cavity; * premenopausal women had negative pregnancy urine test and agreed to use high-efficiency contraceptive measures during the study period. exclusion criteria: * drug sensitivity test or molecular drug sensitivity results show that the drug resistance (except isoniazid) or any component of the drug has a history of allergy, or is taking any drug that is contraindicated to the drug in the short-term treatment program; * severe renal insufficiency (creatinine clearance rate (crcl) less than 30 ml / min). * liver function impairment (alt and / or ast level 3 times higher than the upper limit of laboratory reference value, if it is temporary increase, it can be included after treatment recovery); * those who are unable to participate in or comply with the treatment and follow-up; * q-t interval \> 450 millisecond; * have a history of cardiovascular diseases or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction state; * pregnant or lactating women; * those who are unable to take oral drugs; * those who are currently participating in other clinical trials; * patients with hiv positive or active viral hepatitis.

Keywords: tuberculosis, rifampin resistant, oral, shorter.
a study to compare the bioequivalence and safety of jhl1101 and rituximab in cd20 positive b cell lymphoma patients

Conditions: B Cell Lymphoma

Summary: this is a multicenter, randomized, double-blind, parallel group study to compare the pk, safety, tolerability, immunogenicity and pd of jhl1101 vs rituxan in subjects with cd20-positive b cell lymphoma. the study duration is 13 weeks. approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either jhl1101 (n=64) or rituxan (n=64). each subject will receive one intravenous (iv) infusions of the investigational product (ip) at the dose of 375mg/m2 on day 1. assessments of pk, safety, tolerability, immunogenicity, pd, and efficacy will be collected over the following 13-week period.


Eligibility criteria:
inclusion criteria: 1. cd20-positive b-cell lymphoma. 2. obtained cr (complete remission) or cru (uncertain complete remission) after the prior therapy 3. 18 years to 75 years 4. signed an informed consent 5. adequate organ function, including the following * absolute neutrophil count (anc) ≥ 1,500/ul; platelet count ≥ 75,000/ul; hemoglobin ≥ 8 g/dl * total bilirubin ≤ 1.5 times the upper limit of normal (uln), aspartate transaminase (ast) and/or alanine aminotransferase (alt) ≤ 2.5 times uln * serum creatinine ≤ 1.5 times the uln 6. eastern cooperative oncology group (ecog) performance status of 0 to 1 7. chemotherapy: must not have received within 8 weeks of entry onto this study 8. radiotherapy: must not have received within 4 weeks of entry onto this study 9. recovery (to baseline or to grade 1 or less) from prior treatment-related toxicities except alopecia 10. aagreement to practice contraception 11. more than 6 months life expectancy. exclusion criteria: 1. received any investigational drug within 28 days prior to study enrollment 2. received blood transfusion or any therapies with erythropoietin (epo), granulocyte-stimulating factor (g-csf) or granulocyte-macrophage colony-stimulating factor (gm-csf) within 14 days prior to study enrollment 3. received previous immunotherapy 4. received or plan to receive a live vaccine within 28 days of study enrollment 5. major surgery within 28 days of study enrollment 6. received systemic steroid therapy with 28 days of study enrollment 7. received or plan to receive the hematopoietic cell transplant 8. history of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment 9. known allergic reactions against monoclonal antibody or rituximab. 10. received rituximab or other anti-cd20 monoclonal antibody 11. blood concentration of rituximab \> 10 ug/ml during screen visit 12. human immunodeficiency virus (hiv) positive 13. hepatitis c virus (hcv) antigen and antibody positive 14. hepatitis b virus surface antigen (hbsag) positive 15. body mass index (mbi) ≥ 28 kg/m2