Kornimate/medical-research-clean huggingface dataset:
use of dual-light photodynamic therapy as an adjunct to periodontal treatment in smokers

Conditions: Periodontitis; Dual- Light Photodynamic Therapy; Smoking, Cigarette; Non-surgical Periodontal Therapy

Summary: the goal of this controlled clinical trial is to investigate the impact of regular home use of lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (nspt) alone on biofilm removal and host response in stage iii and grade c smoking periodontitis patients at 6 months.the main question aims to answer is: • does regular use of dual-light photodynamic therapy benefit nspt in stage iii and grade c smoking periodontitis patients? 30 participants will be asked to use lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. both of these groups will receive nspt and will be followed for 6 months from baseline.

the objective of this study is to investigate the impact of regular home use of lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in stage iii and grade c smoking periodontitis patients at 6 months. lumoral® is based on a dual-wavelength led light that activates lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ros). ros and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. this device is designed for home use. therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. in order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the lumoral device® as an adjunct to the periodontal treatment. the patients who receive the device will use it every day for four months. both groups will be followed for 6 months.

Eligibility criteria:
inclusion criteria: * periodontal disease stage iii and grade c with at least 6 sites with probing depth (pd) and clinical attachment loss (cal) ≥5 mm and bleeding on probing (bop) ≥15 teeth * aged ≥35 * smokers smoking ≥10 cigarettes per day exclusion criteria: * patients allergic to indocyanine * patients with active carious lesions * need for prophylactic antimicrobial coverage * scaling and root planing in the previous 6 months * non-smoking status or smoking less than 10 cigarettes per day * antimicrobial therapy in the previous 6 months * immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis) * long-term use of medication that could interfere with periodontal response (e.g. biphosphonates) * pregnancy or lactation

Keywords: periodontitis periodontal diseases photodynamic therapy photothermal therapy smoking non-surgical periodontitis therapy
effectiveness of combined manual therapy and pulmonary exercises on ventilatory function in patients with restrictive lung diseases

Conditions: Study the Effectiveness of Combined Manual Therapy and Pulmonary Exercises on Ventilatory Function in Patients with Restrictive Lung Diseases

Summary: this research investigates the effect of selective manual therapy techniques on chest expansion, pulmonary function (fvc, fev1, and fev1/fvc ratio), and functional capacity, in restrictive lung disease patients. the research hypothesis will be that no statistically significant difference would be found between manual therapy combined to conventional treatment and conventional treatment alone in restrictive lung disease patients.

a chest physician diagnosed 72 subjects with mild to moderate restrictive lung diseases based on history, physical examination, and a ratio of fev1/fvc above 80%. male subjects meeting the following criteria will be included: age ranged from 50 to 60 years, bmi was 18-25 kg/m2, if a patient had a history of hiatus hernia, substantial gastro-esophageal reflux, osteoporosis, acute cardiac events within the last six weeks, congestive heart failure, acute exacerbation, exacerbation six months before, active hemoptysis, or malignant disease, they will be excluded from the study. the subjects who consented to will be involved and met the recruitment standards randomly assigned. a computer-generated block randomization program will be used. to eliminate bias between groups, the subjects will be randomized into four-person blocks with a 1:1 allocation ratio. to ensure disguised allocation, the randomization code will be maintained in sealed, opaque envelopes consecutively numbered. a single external party will be responsible for administering the randomization

Eligibility criteria:
inclusion criteria: restrictive lung diseases pneumonia pulmonary edema pleural effusion pneumothorax exclusion criteria: hiatus hernia substantial gastro-esophageal reflux acute cardiac events osteoporosis congestive heart failure active hemoptysis malignant disease
the treatment of newly diagnosed cd19+mixed phenotype acute leukemia in adults

Conditions: Acute Leukemia

Summary: evaluation the efficacy and safety of the combination of injectable bevacizumab, low-intensity chemotherapy, and venula in the treatment of newly diagnosed cd19+mixed phenotype acute leukemia in adults


Eligibility criteria:
inclusion criteria: 1. patients fully understand this study, voluntarily participate and sign an informed consent form (icf); 2. age: 18-75 years old (including boundary values of 18 and 75); 3. clinically diagnosed adult mixed phenotype acute leukemia (who 2016 criteria) patients with cd19 positivity exclusion criteria: the subject's previous history of anti-tumor treatment meets one of the following conditions: 1. individuals who have previously received bevacizumab 2. individuals who have received car-t therapy or other gene modified cell therapies prior to screening; 3. within 5 half lives of the first use of the investigational drug, having received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participating in other clinical trials and receiving clinical trial medication;
intra-operative fraction of inspired oxygen and lung injury in coronary artery bypass grafting surgery

Conditions: Lung Injury; Pulmonary Complication

Summary: this study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative fio2 and postoperative pulmonary complications with lung injury.

hyperoxia is common in cardiac surgery and is easy to prevent by adjusting fio2. since there is no prospective study on different fio2 and postoperative pulmonary complications (ppcs) during cardiac surgery. we hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and ppcs than normoxia. the objective of this trial is to compare postoperative ppcs and other outcomes between hyperoxia and normoxia strategy by pao2/fio2 in cabg patients.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 * bmi from 20 to 39.9 * asa ii/iii * undergoing isolated selective on-pump cabg through median sternotomy * subsequent admission to an intensive care unit (icu). exclusion criteria: * with severe chronic obstructive pulmonary disease (copd) * pregnant woman. * with current acute coronary syndrome (\<1 week) * severe anemia (hemoglobin \<10g/l) * preoperative supplemental oxygen requirement to maintain arterial o2 of 92%, * right to left shunt in heart * carotid stenosis defined as \>50% stenosis of either carotid artery, * cardiac surgery that requires intraoperative circulatory arrest, * current use of dialysis, * one-lung ventilation during surgery, * recent smoking (within 1 month), * non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure, * perioperative allogenic transfusion with red blood cell, plasma or platelet
local measures to prevent diabetes in the værnes region.

Conditions: Diabetes Mellitus Type 2; Obesity

Summary: this is a development project involving four different municipalities in central norway. the aim is to identify adults with overweight and with an increased risk of developing diabetes mellitus type 2, then to prevent the disease to develop by the means of a behaviour change programme. the programme is group based.


Eligibility criteria:
inclusion criteria: * living in central norway * find risc score \> 15 * written, informed consent exclusion criteria: * severe mental disorder * not being able to function in the group programme

Keywords: prevention public health community health services norway
dose escalation of oxi4503 as single agent and combination with cytarabine w/subsequent ph 2 cohorts for aml and mds

Conditions: Acute Myelogenous Leukemia; Myelodysplastic Syndromes

Summary: phase 1 will investigate maximum tolerated dose of oxi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory aml or mds. phase 2 will investigate overall response rate of oxi4503 in combination with intermediate-dose cytarabine in 1) subjects with mds after failure of 1 prior hypomethylating agent (arm a) and 2) subjects with relapsed and refractory aml after treatment failure of up to 1 prior chemotherapy regimen (arm b).

phase 1 dose escalation component will assess the safety, pk/pd, and preliminary efficacy of oxi4503 as a single agent in subjects with relapsed/refractory aml and mds, and the safety and pk/pd of the combination of oxi4503 with intermediate-dose cytarabine in subjects with aml/mds. phase 2 will assess the preliminary efficacy of the oxi4503+cytarabine combination in 2 cohorts.

Eligibility criteria:
inclusion criteria: 1. provide informed consent 2. ≥ 18 years of age 3. phase 1 (dose escalation) subjects must have either: * aml that has failed to achieve complete remission or morphologic complete remission or * mds - marrow blasts must be \> 5% and disease failed at least 1 prior hypomethylating agent 4. phase 2 (expansion) subjects must have either mds or relapsed/refractory aml 5. eastern cooperative oncology group performance status 0, 1, or 2 6. total bilirubin ≤ 2 7. serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels ≤ 2.5 times upper limit of normal (uln) 8. serum creatinine \< 2.5 times uln 9. prothrombin time (pt)/international normalized ratio and (ptt) in normal range ± 25% 10. women of child-bearing potential 11. males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods exclusion criteria: 1. acute promyelocytic leukemia 2. absolute peripheral blood myeloblast count greater than 20,000/mm3 3. uncontrolled hypertension 4. history of congenital long qt syndrome or torsades de pointes 5. pathologic bradycardia or heart block 6. prolonged baseline qtc 7. hiistory of ventricular arrhythmia 8. myocardial infarction and/or new st elevation 9. any history of hemorrhagic stroke 10. symptomatic congestive heart failure 11. major hemorrhagic event within 28 days 12. suggestive central nervous system involvement with leukemia 13. any open wound 14. pregnant and nursing subjects are excluded 15. treatment with any anticancer therapy 16. treatment with colchicine is excluded. 17. psychiatric disorders that would interfere with consent

Keywords: aml mds
double pig tail stent-assisted fixation of fully covered metal stents for the treatment of benign duodenal strictures

Conditions: Benign Duodenal Stricture

Summary: double pig tail stent-assisted fixation of fully-covered metal stents for the treatment of benign duodenal strictures

this study uses a double pig-tail stent for cross fixation of a fully-covered stent in the duodenum to reduce the incidence of displacement and ensure the stent can effectively expand the narrowed area, thereby alleviating patient symptoms. the aim of this study is to explore the safety and efficacy of a double pig-tail stent-assisted fixation of a fully-covered stent for the treatment of benign duodenal strictures, further clarifying its long-term efficacy and providing strong support for the placement of fully-covered stents in treating benign duodenal strictures.

Eligibility criteria:
inclusion criteria: 1. the subjects voluntarily signed the informed consent form for this trial; 2. patients diagnosed with benign duodenal stricture; 3. symptoms of upper gastrointestinal obstruction, such as nausea, vomiting, abdominal pain, or changes in bowel habits, occurring before admission or during hospitalization; 4. patients with refractory strictures who have failed multiple balloon dilations; 5. age \< 75 years. exclusion criteria: 1. gastrointestinal perforation; 2. distal small bowel obstruction or multiple segments of small bowel obstruction; 3. coagulation disorders; 4. strictures or obstructions caused by malignant tumors; 5. severe comorbidities involving the heart, brain, lungs, kidneys, etc.

Keywords: duodenal stricture fully covered stent
reveal linq™ heart failure

Conditions: Heart Failure

Summary: the purpose of the linq™ hf study is to characterize reveal linq™ derived data from patients with heart failure by assessing the relationship between changes in linq™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (adhf) events.

the study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. the study is expected to be conducted at up to 30 centers in the united states. up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when medtronic and/or regulatory requirements have been satisfied per the clinical investigation plan and/or by a decision by medtronic or regulatory authority, whichever occurs first. the expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up. the linq™ hf study is a non-significant risk investigational device exemption (ide) study. the study is utilizing the reveal linq™ device with an investigational linq™ hf ramware download.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient (or patient's legally authorized representative) is willing and able to provide written informed consent * patient is willing and able to comply with the protocol, including follow-up visits and carelink transmissions * patient is nyha class iii, per most recent assessment or at any time within 30 days prior to enrollment * patient had a hf event (hf event defined as meeting any one of the following three criteria): 1. admission with primary diagnosis of hf within the last 6 months, or 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months: * admission with secondary/tertiary diagnosis of hf * emergency department * ambulance * observation unit * urgent care * hf/cardiology clinic * patient's home, or 3. patient had the following bnp/ntpro-bnp within the last 3 months: if ef ≥ 50%, then bnp\> 200 pg/ml or ntpro-bnp \> 400 pg/ml or if ef \ 400 pg/ml or ntpro-bnp \> 800 pg/ml exclusion criteria: * patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment) * patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager * patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve * patient has existing ipg, icd, crt-d or crt-p device * patient has severe renal impairment (egfr \<25ml/min)
early initiated vasopressor therapy in the emergency department

Conditions: Shock; Shock, Septic; Hypotension; Hypotension and Shock; Hypotension Symptomatic; Hypovolemia; Hypovolemic Shock; Hypovolemic

Summary: the goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the danish emergency departments (ed). the main questions it aims to answer are: if early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ed can * improve time to shock control. * reduce the need for icu admittance. * decrease mortality. participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their emergency department stay. after completion of the treatment in the emergency department, patient data will be extracted from the bed-side measurements, electronic health records and national registers. patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves. researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in danish emergency departments.

please refer to the full protocol.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as: 1. sbp \ 2.0 mmol/l, 2. physician defined blood pressure for the individual patient combined with a lactate \> 2.0 mmol/l 3. either sbp \< 100mmhg or map \< 65mmhg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician. * received at least 500ml of intravenous fluid before study inclusion (including prehospital administration) within the first 4 hours of ed arrival. * clinical frailty score (cfs) of ≤4. if cfs is ≥5 and the treating physician find the patient suitable for icu admittance, the participant can be enrolled, if the on-call icu doctor would accept the patient for icu admittance. if the treating physician is unsure of icu eligibility, regardless of cfs score, the patient should be consulted with the icu consultant before study inclusion. exclusion criteria: * cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician. * fertile women (\<60 years of age) with positive urine human gonadotropin (hcg) or plasma-hcg or women breastfeeding. * patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for icu admittance decided by either the treating physician or icu consultant. * known allergy to noradrenaline.

Keywords: peripherally infused noradrenaline fluid therapy fluid treatment non-hemorrhagic shock and hypotension emergency department
salvage immunotherapy and chemotherapy in esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy

Conditions: Esophageal Squamous Cell Carcinomas

Summary: this is an investigator-initiated, single-arm, exploratory clinical study.the study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. the purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.


Eligibility criteria:
inclusion criteria: 1. diagnosed with stage ii/iii carcinoma of the esophagus squamous cell carcinoma. 2. completed pre-operative chemoradiotherapy followed by surgery 3. diagnosed with residual pathologic disease after being surgically rendered free of 4. disease with negative margins following complete resection 5. nonresponding to initial neoadjuvant chemoradiotherapy(trg3 and trg4) exclusion criteria: 1. known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes) 2. have a history of immunodeficiency, including hiv positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation； 3. interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction； 4. there are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of nyha class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or interventional supraventricular or ventricular arrhythmia； 5. have a tendency to hereditary bleeding or coagulopathy. clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above； 6. has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss); 7. allergic reactions to test drugs for this application； 8. pregnant or lactating women； those whom the investigator considered unsuitable for inclusion。