Kornimate/medical-research-clean huggingface dataset:
antimicrobial photodynamic therapy with erythrosine and blue light on dental biofilm bacteria

Conditions: Dental Plaque

Summary: the objective of this study is to investigate the effect of antimicrobial photodynamic therapy mediated by erythrosine and blue led in the reduction of bacteria in dental biofilm. this clinical trial will be carried out with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the dental clinic of universidade metropolitana de santos. a split-mouth model will be used (n = 30), with group i control - conventional treatment and group ii - conventional treatment and antimicrobial photodynamic therapy (apdt). the bicarbonate jet will be used to remove dental biofilm in both groups. the treatment will be carried out in 1 session. apdt will be performed before cleaning/prophylaxis, only in group ii. participants will rinse with the photosensitizer erythrosine (diluted to 1mm) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. then, the d-2000 led (dmc) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mw/cm2. irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. each irradiation point will be approximately 0.4 cm2. the microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. two collections will be performed in each experimental site before irradiation, and immediately after the irradiation procedure (group ii) or prophylaxis (groups i and ii). biofilm samples will be collected before and after exposure, respectively, and sent to the microbiological laboratory for colony counting. after this period, the cfu's will be counted and the data will be submitted to statistical analysis for comparison of pre and post-treatment results and between groups (conventional x apdt).


Eligibility criteria:
inclusion criteria: * the participant must present between 25% and 50% of biofilm index; * have at least 20 teeth present, without clinical probing depths greater than 3 mm. exclusion criteria: * smokers; * uncontrolled diabetics or hypertensives; * cancer or its treatment; * pregnant women; * use of antibiotics in the last 6 months; * coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia and immunosuppression); * patients undergoing orthodontic treatment.
evaluation of etc-1002 vs placebo in patients receiving ongoing statin therapy

Conditions: Hypercholesterolemia

Summary: the purpose of this research study is to see how etc-1002 is tolerated in the body and how etc-1002 affects the levels of ldl-c (bad cholesterol) in patients receiving ongoing statin therapy.

approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated ldl-c will be randomized in a ratio of 1:1:1 to receive either etc-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. this study will explore the safety and efficacy of etc-1002 when given to patients receiving statin therapy.

Eligibility criteria:
inclusion criteria: * fasting, calculated mean ldl-c ≥130 mg/dl and ≤220 mg/dl * fasting mean tg level ≤400 mg/dl * stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily) exclusion criteria: * clinically significant cardiovascular disease within 12 months of screening * current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued * type 1 diabetes or uncontrolled type 2 diabetes * use of metformin or thiazolidinediones (tzd) within 4 weeks of screening * history of chronic musculoskeletal symptoms such as fibromyalgia * uncontrolled hypothyroidism * liver disease or dysfunction * renal dysfunction or nephritic syndrome * gastrointestinal conditions or procedures or surgeries * hematologic or coagulation disorders or low hemoglobin levels * hiv or aids * history of malignancy * history of drug or alcohol abuse within 2 years * use of experimental or investigational drugs within 30 days of screening * use of etc-1002 in a previous clinical study

Keywords: statin ldl cholesterol
pulsta® transcatheter pulmonary valve korean multicenter study

Conditions: Congenital Heart Defect; Pulmonary Valve; Insufficiency, Congenital; Pulmonary Valve Stenosis

Summary: the purpose of this study is to evaluate the safety and effectiveness of the tpv in patients with pulmonary valve dysfunction.

the tpv is indicated for use in patients with previous undergone replacement of bioprosthetic valve or conduit due to either pulmonary valve atresia, stenosis, regurgitation or a combination of them and present with dysfunctional right ventricular ourflow tract (rvot) requiring treatment for severe pulmonary regurgitation and/or rvot conduit obstruction. consecutive subject data should be collected at discharge, 1, 3, 6 month, and 1-5 years post tpv implantation.

Eligibility criteria:
inclusion criteria: * body weight greater than or equal to 30 kilograms * pulmonary regurgitation ≥moderate pulmonary regurgitation (pr) (≥3+) or rvot conduit obstruction with mean gradient \>35mmhg by echocardiography * pulmonary artery annulus or in situ conduit size of ≥16 and ≤26mm * patient willing to provide written informed consent and comply with follow-up requirements exclusion criteria: * pre-existing mechanical heart valve in any position * obstruction of the central veins (pulmonic bioprosthesis delivery system to the heart) * coronary artery compression * a known hypersensitivity to aspirin or heparin * immunosuppressive disease * active infectious disease (e.g. endocarditis, meningitis) * estimated survival less than 6 months * female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
biomarkers in concussion

Conditions: Concussion, Mild; Concussion, Intermediate; Concussion, Severe

Summary: this will be an observational study measuring serum neurofilament light chain concentrations and associated symptoms, with a control branch, and a post-concussion branch.


Eligibility criteria:
inclusion criteria: over 12 years of age athletes participating on a sports team willing to participate; undergo blood draws either weekly or every two weeks, depending on arm of study. exclusion criteria: existing active neurodegenerative disorder (ie severe tbi) active peripheral nerve disorder (ie diabetic neuropathy)
an open label, single centre mass balance c14 study in patients with acute myeloid leukaemia (aml)

Conditions: Acute Myeloid Leukaemia

Summary: the purpose of the study is to assess how azd1152 is absorbed or excreted in and out of the body in patients with acute myeloid leukaemia (aml).


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory aml for which no standard therapies are anticipated to result in durable remission. or, patients with newly diagnosed aml who are not considered to be suitable for standard induction and consolidation chemotherapy * ability to stay in hospital for up to 9 days on the \[14c\] azd1152 treatment cycle. * subjects who have relapsed \> 1 year following myeloablative therapy with allogeneic bone marrow or stem cell transplantation may be eligible if they have no or limited evidence of extensive graft-versus-host disease exclusion criteria: * qtc interval ≥470 ms calculated from a single ecg reading or a mean of 3 ecg readings using fridericia's or bazett's correction * administration of hydroxyurea to control peripheral blood counts is prohibited within 24 hours prior to first dose of study drug * any chemotherapy or radiotherapy within 14 days prior to starting the study (not including palliative radiotherapy at focal sites)

Keywords: acute myeloid leukaemia (aml) aml azd1152 pharmacokinetics
bdx 7 day ecg patch: electrode adhesion clinical study

Conditions: Cardiac Patients; ECG Monitoring

Summary: the purpose of this research study is to learn if a new 7 day patch ecg recording monitor can serve the same purpose as standard monitoring systems. the new 7day patch is significantly smaller and lighter than previous ecg recorders.

the primary purpose of this research is to evaluate ecg signal quality of the bdx 7 day ecg patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

Eligibility criteria:
inclusion criteria: * cardiac patient volunteers (5 male and 5 female) exclusion criteria: * skin rash or infection over the sternum * sternal incision within 3 months from the date of enrollment
improved diagnostics for paediatric tuberculosis

Conditions: Tuberculosis

Summary: improved diagnostics for paediatric tuberculosis

research question: to test the feasibility of tika system to reliably detect mycobacterium tuberculosis in faeces of paediatric patients with tuberculosis study design: non-randomised diagnostic proof of concept feasibility study study participants: patients with or suspected to have tuberculosis

Eligibility criteria:
inclusion criteria: * any patient under the age of 21 years with the following diagnosis for whom informed consent can be obtained will be offered to be included in the trial. * latent tuberculosis * culture confirmed tuberculosis * clinically suspected tuberculosis exclusion criteria: * any patient over 21 * any child or adult/guardian unable to give informed consent * any persons under detention will not be included. * any patient who is unable to give a sample.

Keywords: paediatric tuberculosis
effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: adhesive capsulitis (ac) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (fs). adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. this study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. this study will be a randomized control trial and data will be collected from haq orthopedic hospital. sample size is 20 calculated by using g power and adding 20 % attrition.

non-probability convenient sampling will be used. participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group a will be treated gongs mobilization and group b will be treated with reverse distraction technique. conventional therapy will be given to both groups as base line treatment. both groups have 4 sessions per week for 4 weeks. all participants will be evaluated before and after the treatment using numeric pain rating scale (nprs), shoulder pain and disability index (spadi) and goniometer.

Eligibility criteria:
inclusion criteria: * both males and females. * diagnosed case of unilateral adhesive capsulitis. * age group of 40-60 years. * stage 2 and 3 of adhesive capsulitis. * diabetes mellitus type ii. * patients with decreased rom (less than or equal to 120 degrees), pain, and mild to moderate levels of type ii diabetics (below or equal to 200 mg/dl). * no history of shoulder surgeries to the affected shoulder. exclusion criteria: * systemic arthritic conditions of the shoulder (rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) . * disorders of the cervical spine . * corticosteroids injections in the affected shoulder in preceding 6 weeks. * skin lesions or bruises around the shoulder. * shoulder injuries such as rotator cuff tear. * fracture in and around the shoulder joint.
short-term physical function outcomes in severe covid-19 patients admitted to icu for invasive mechanical ventilation

Conditions: COVID-19

Summary: little is known about the physical function outcomes in patients with severe covid-19 patients who are admitted to intensive care unit (icu) for invasive mechanical ventilation. the purpose of this study is to evaluate the short-term impact on physical function before hospital discharge in subjects with severe covid-19 who have survived icu admission for invasive mechanical ventilation.

design: an observation cohort study conducted in a tertiary hospital. methods: data will be collected from patients along the icu-hospital discharge continuum, will be analysed and non-parametric tests will be used to explore association between variables. outcome measures: muscle strength, as a component of physical function, will be evaluated with the medical research council sum score (mrc- ss) at discharge from icu and at hospital discharge; the functional status score for the icu (fss-icu) will also be assessed at hospital discharge. data on participants' demographics, icu admission and hospital admission will also be collected. significance of the research: understanding how physical function is affected in patients with severe covid-19 may help develop future prevention, therapeutic and follow-up strategies that improve quality of care and outcomes in this specific group of patients. findings from this study may be useful to design future larger cohort studies and experimental trials.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with covid-19 who have required admission to icu for invasive mechanical ventilation; * have received invasive ventilation \> 24 hours; * have been successfully weaned from mechanical ventilation \> 48 hours; * were independently able to mobilise prior to current hospital admission (this includes subjects who used a walking stick or another gait aid to mobilise. exclusion criteria: * subjects or proxies with inability to communicate in spanish fluently; * cognitive impairment prior to icu admission; * proven neurological impairment or neuromuscular disorder; * cerebrovascular accident during hospital stay; * previous organ transplant; * pregnancy; * unstable fractures or any other injuries that would require medical bed rest.

Keywords: physical function functional outcomes strength intensive care unit rehabilitation
cd22 targeting car-t therapy against b cell hematological malignancies

Conditions: Recurrent or Refractory B Cell Malignancy

Summary: cd19 expression on b cell frequently lost after cd19-targeting car-t therapy. in present study, we construct a cd22-targeting chimeric antigen receptor to overcome this issue.

cd19 is an ideal target with great potential for treating b-cell-derived hematological malignancies. although the complete remission rate is as high as 93% by using cd19-targeting car-t technology, approximately 60% patients will have recurrent disease. among all the recurrent patients, two thirds is revealed to loss their cd19 expression on b cell surface. for overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target cd22 molecule on b cells.

Eligibility criteria:
inclusion criteria: * greater than four years of age * survival time\>12 weeks * b cell hematological malignancies by pathological examination * chemotherapy failure or recurrent b cell malignancy * creatinine\< 2.5mg/dl * glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level * bilirubin\<2.0mg/dl * karnofsky performance status\>50% at the time of screening * adequate pulmonary, renal, hepatic, and cardiac function * fail in autologous or allogenic haemopoietic stem cell transplantation * free of leukocytes removal contraindications * voluntarily join car-t clinical trial * understand and sign written informed consent exclusion criteria: * pregnant or nursing women * active hepatitis b, active hepatitis c, or any human immunodeficiency virus (hiv) infection at the time of screening * feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated. * abnormal vital signs * highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 * general infection or local severe infection, or other infection that is not controlled * dysfunction in lung, heart, kidney and brain * severe autoimmune diseases * other symptoms that are not applicable for car-t
uncalibrated pulse contour to assess fluid responsiveness in off pump cardiac surgery

Conditions: Coronary Surgery

Summary: the goal of this observational study is to compare the performance of uncalibrated pulse wave contour analysis compared with transesophageal echocardiography (tee) to assess response to a vascular filling test during beating-heart coronary artery bypass surgery, in people over age of 18; hospitalized for scheduled beating heart bypass surgery the aim question is to evaluate the ability of a less invasive cardiac output monitor (uncalibrated pulse wave contour analysis) compared with a reference cardiac output measurement (transesophageal echocardiography) to enable optimization of vascular filling by good assessment of the response to vascular filling in a high-risk perioperative patient population. as part of hemodynamic monitoring, every patient undergoing beating-heart coronary bypass surgery is fitted with a radial arterial catheter immediately after induction of anesthesia, enabling continuous measurement of blood pressure. hemodynamic optimization in these patients also involves fitting a transesophageal ultrasound probe to optimize cardiac output using the various therapies available (vascular filling, vasopressors, inotropes). a specific sensor (flotrac°, hemosphere, edwards°) will be connected to the arterial pressure line to obtain a systolic ejection volume value by analyzing the contour of the uncalibrated pulse wave. the hemodynamic management of the patient, and the decision to perform a vascular filling test, will be left to the discretion of the practitioner in charge of the patient in the operating room.


Eligibility criteria:
inclusion criteria: patient : * 18 years of age and older * hospitalized for scheduled beating-heart coronary bypass surgery * beneficiary of a social security plan * not opposed to participating exclusion criteria: * patients undergoing surgery with extracorporeal circulation * patients with a history of surgery or intra-esophageal pathology contraindicating tee * patient refusing to participate in the study * unavailability of tee or uncalibrated pulse-wave contour device * minors * protected adults, adults unable to give consent and not under protective supervision * persons deprived of liberty, hospitalized without consent * pregnant women, parturients and nursing mothers * patients not affiliated to the social security system * emergency situations

Keywords: vascular filling systolic ejection volume uncalibrated pulse-wave contour analysis
ultrasound guided stellate ganglion block in postural tachycardia syndrome

Conditions: Postural Tachycardia Syndrome

Summary: this single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (sgb) in a cohort of rigorously phenotyped patients with postural tachycardia syndrome (pots). by assessing the effects of sgb, this study seeks to determine its viability as an intervention for symptom control in pots.

postural tachycardia syndrome (pots) is a heterogeneous condition affecting approximately 0.2% of the global population, predominantly young women of childbearing age. it is characterized by significant functional impairment and a constellation of symptoms, including lightheadedness, cognitive dysfunction, blurred vision, irritability, palpitations, and chest discomfort, which occur upon standing and improve when lying down. although current pharmacological and non-pharmacological treatments alleviate symptoms for some patients, many remain significantly disabled. these challenges highlight the urgent need for novel treatment strategies, particularly non-pharmacological approaches. this study is a randomized controlled trial with a control group. the study team will enroll 20 patients with pots, assigning 10 to the intervention group and 10 to the control group. the goal of the study is to evaluate the effectiveness of sgb in improving heart rate, markers of sympathetic hyperactivity, and pots symptoms comparing to a sham saline injection.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years of age) diagnosed with pots * ability to provide informed consent * ability to comply with 3 follow up visits * english speaking and capable of signing informed consent and complying with protocol requirements exclusion criteria: * allergy to local anesthetics * severe coagulopathy * history of or currently being treated for clinically significant ongoing cardiac arrhythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of pots * inability to maintain a stable medication regiment for the duration of the study

Keywords: stellate ganglion block regional anesthesia nerve block
parenteral fish oil in major laparoscopic abdominal surgery

Conditions: Gastric Tumor; Pancreatic Tumor; Liver Tumor

Summary: the aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.

postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed mct/lct) or a mixture of mct/lct and fish oil omegaven for 7 days. full blood count, biochemistry and coagulation are routinely assessed. fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°c pending analysis. the primary endpoint was numbers of infective complications.secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.

Eligibility criteria:
inclusion criteria: * patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition exclusion criteria: * metabolic disease * chronic kidney or liver failure * shock * contraindications for lipid administration * pn during the 15 days before hospitalisation
ocular tolerance and intraocular pressure (iop) effects of zylet versus tobradex

Conditions: Inflammation

Summary: phase iv, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (iop) effects of zylet wth that of tobradex in healthy volunteers, when either product was administered qid (at approximately 4-hour intervals) for 28 days.


Eligibility criteria:
inclusion criteria: * in good general health based on investigator judgment * able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study * possessing a best corrected visual acuity of at least 20/40 in each eye * for females, using reliable contraception and a negative urine pregnancy test prior to study entry exclusion criteria: * contact lenses worn within 30 days prior to enrollment or during study period * known hypersensitivity to study medication or any component * presence of significant ocular or systemic disease that might interfere with the interpretation of the results * a need for administration of chronic topical ocular or systemic medications of any kind during the study. * participation in an opthalmic drug or device research study within 30 days prior to entry