Kornimate/medical-research-clean huggingface dataset:
magictouch sirolimus drug coated balloon catheter for the treatment of coronary lesions

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to demonstrate the efficacy of magictouch dcb in reducing late lumen loss / suppressing neointimal tissue formation as assessed by quantitative coronary angiography / intravascular ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

prospective, multicenter, randomized study designed to enroll 60 subjects with in-stent restenosis, to demonstrate the efficacy of magictouch drug-coated balloon in reducing late lumen loss / suppressing neointimal tissue formation as assessed by quantitative coronary angiography / intravascular ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Eligibility criteria:
inclusion criteria: 1. the patient must be ≥18 and ≤ 80 years of age 2. symptomatic ischemic heart disease; 3. acceptable candidate for coronary artery bypass graft (cabg) or angioplasty; 4. target lesion located in a native coronary artery 5. target lesion (maximum length is 15 mm by visual estimate) covered by a single balloon; 6. reference vessel diameter must be ≥3.0 to ≤ 3.5 mm by visual estimate; 7. target lesion ≥50% and \<100% stenosed by visual estimate 8. restenosis of initially stented main vessel. exclusion criteria: 1. pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure; 2. patient has had a known diagnosis of acute myocardial infarction (ami) within 72 hours preceding the index procedure; 3. lesions in bypass grafts or bifurcations 4. any non-target vessel or lesion intended to be treated during the index procedure, which is an unprotected left main, ostial lesion, chronic total occlusion (cto), heavily calcified, bifurcation, vein grafts, have angiographic evidence of thrombus, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty; 5. patient presents with cardiogenic shock; 6. patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion 7. unprotected left main coronary artery disease with ≥50% stenosis; 8. totally occluded target vessel (timi flow 0); 9. calcified target lesion(s) which cannot be successfully pre-dilated; 10. a significant (\>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single balloon 11. diffuse distal disease to target lesion with impaired runoff; 12. left ventricular ejection fraction (lvef) ≤30% (lvef must be obtained within 1 months prior to the index procedure).

Keywords: drug-eluting balloon in-stent restenosis
association between different parameters of nutritional assessment and clinical outcomes in cancer patients

Conditions: Cancer; Postoperative Complications; Sarcopenia

Summary: malnutrition in oncologic patients has a negative impact on post- surgical recovery, survival and quality of life. the etiology of malnutrition in cancer patients is multifactorial, therefore, the nutritional assessment should be carried out by different parameters. the objective of this study is to investigate the association and prognostic value of five distinct methods of nutritional assessment (molecular, body composition, functional, anthropometric and subjective) in relation to postoperative complications and short-term survival in patients with cancer. regarding the molecular parameter, mtor signaling pathwayon will be assessed in rectus muscle samples, harvested in the moment of the operation. body composition was assessed by computed tomography (ct) and bioelectrical impedance test was conducted to evaluate the phase angle. handgrip strength was used to determine functionality. the percentage of weight loss in relation to usual weight was the anthropometric parameter used. subjective global assessment (sga) was used to provide the nutritional diagnosis. postoperative complications were classified according to the dindo and clavien classification. overall time survival was the period between the first assessment of the patients until death or end of follow-up. chi-square test, t test, kaplan-meier method and the log rank test and regression analysis will be used (p \<0.05).


Eligibility criteria:
inclusion criteria: * diagnostic cancer confirmed * over 18 years old * accepted the terms of survey exclusion criteria: * tumor synchronic * inflamattory disease * under 18 years old * no accepted the terms of survey
discontinuation of dasatinib in patients with chronic myeloid leukemia-cp who have maintained complete molecular remission for two years; dasatinib stop trial

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (cmr) while on dasatinib.


Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia in the chronic phase. * patients with bcr-abl-negative checks. * 15 years old over. * ecog performance status (ps) score 0-2. * adequate organ function (hepatic, renal and lung). * signed written informed consent. exclusion criteria: * a case with the double cancer of the activity. * women who are pregnant or breastfeeding. * patients with complications or a history of severe. * patients with mutation of t315i、f317l、v299l. * patients with additional chromosome abnormalities. * the case of pleural effusion with poor control. * patients with a history of hematopoietic stem cell transplantation.
towards a viral etiology of periodontal disease in relation to radiotherapy treatment of head and neck cancers

Conditions: Periodontal Disease

Summary: the treatment of otolaryngology (olr) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. the management of these oral complications is a priority in olr oncology. the aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing. this project proposes to deepen the investigation with two main objectives: 1. to study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls. 2. to study in vitro the effects of irradiation on the replication ebv (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with ebv that existence were recently discovered.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx * patients naive treatments for head and neck cancers * patients affiliated or beneficiary of a social security scheme * patients who gave informed consent in writing exclusion criteria: * patients treated with neoadjuvant chemotherapy, adjuvant or concomitant * patients taking immunosuppressants after organ transplantation * taking anticoagulants incompatible with dental samples (possible bleeding) * patients edentulous and / or whose dental condition is incompatible with the dental samples
a study to investigate the association of real-world sensor-derived biometric data with clinical parameters and patient-reported outcomes for monitoring disease activity in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (pros) for monitoring disease activity and predicting exacerbations for participants with chronic obstructive pulmonary disease (copd). the cohort of participants with copd will be followed for 3 months. a calibration cohort with non-copd participants will be included and followed for 2 weeks.


Eligibility criteria:
inclusion criteria: for participants with copd: * participants ≥40 and ≤80 years at baseline * diagnosis of copd stage ii to iv * history of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to covid-19 measures) for participants in the calibration cohort: • participants ≥40 and ≤80 years at baseline exclusion criteria: for participants with copd: * clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia \[esp. atrial fibrillation and conduction blocks\]), lung cancer (currently treated) that in the opinion of the investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study * participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices * participants with known allergies or sensitivity to silicon or hydrogel * less than 6 weeks since previous moderate/severe exacerbation for participants in the calibration cohort: * participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices * participants with known allergies or sensitivity to silicon or hydrogel * diagnosis of pulmonary disease including, but not limited to copd, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity
dealing with anxiety: a cognitive behavioural program for diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this study was designed to assess whether a cognitive behavior therapy (cbt) program for diabetes clinic patients was acceptable, improved quality of life and produced measurable change in levels of depression, anxiety and stress.

having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. psychological interventions have been shown to result in improvements in hba1c and depression. reports on psychosocial outcomes are conflicting and there are no studies of quality of life. our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group cbt intervention designed to reduce anxiety as a co-morbidity of diabetes.

Eligibility criteria:
inclusion criteria: * consenting attendees of the hunter area diabetes services rnh diabetes outpatient clinic exclusion criteria: * accessibility problems including: * limited english * developmental disability * physical immobility * geographical distance * extreme age/frailty

Keywords: diabetes cognitive behavioural therapy
left ventricular reverse remodeling in aortic valve replacement with single strip pericardium versus mechanical valve

Conditions: Aortic Valve Stenosis; Aortic Stenosis; Valve Stenoses, Aortic; Aortic Valve Calcification

Summary: aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. valve replacement using mechanical prosthetic valve will have an expensive cost especially in the integrated heart center of cipto mangunkusumo hospital, jakarta, indonesia. in addition to the expensive cost, patients who have mechanical prosthetic valve have an increased risk of infection of the prosthetic valve and developing thrombo-embolism thus have to consume a lifelong anticoagulant therapy that increase risk of bleeding. a surgical technique using autologous pericardium is an alternative to prosthetic valve replacement, one of which is a single pericardium strip technique that uses modified autologous pericardium technique from ozaki et al and duran et al. the objective of this study is to investigate the outcome of aortic valve replacement with a single pericardium strip of autologous pericardium in patients with aortic stenosis. this study will be conducted at the integrated heart center of cipto mangunkusumo hospital, jakarta, indonesia, by using quasi experimental type time series design. subjects are patients with aortic stenosis who are candidates for valve replacement. inclusion criteria is having low to moderate surgical risk (euroscore ii \<5). the sampling method used in this study is non-probability consecutive sampling. this study will assess the outcome of the aortic valve replacement (valve hemodynamic, left ventricular reverse remodelling, sst2, 6mwt) at 3 months and 6 months post-aortic valve replacement. it is expected that aortic valve replacement using a single strip of autologous pericardium will have good valve hemodynamic outcome, yield left ventricular reverse remodelling, decrease sst2 level, show upgrade in 6mwt, and have shorter aortic cross clamp time so that it can be an alternative to aortic valve replacement using mechanical prosthetic valve that is less expensive and have good outcomes in patient with aortic stenosis.


Eligibility criteria:
inclusion criteria: * patients aged more than 10 years old * patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (euroscore ii \<5) * the patient or guardian (the research subject's parent) agrees to follow the study exclusion criteria: * patients who have previously underwent aortic valve replacement * patients with aortic stenosis due to bicuspid aortic valve * patients with autoimmune disease * patients with mixed connective tissue disease

Keywords: aortic stenosis aortic valve replacement single strip pericardium autologous pericardium mechanical valve replacement comparison of left ventricle remodeling
is synchronization more effective during noninvasive ventilation in immediately extubated preterm infants?

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this study is the examination of the hypothesis that synchronized nasal imv as compared to non-synchronized nasal imv will decrease breathing effort in preterm infants immediately after extubation when recovering from respiratory distress syndrome (rds). another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

in this study the investigators plan to test the hypothesis that synchronized nasal imv (s-nimv) as compared to non-synchronized nasal imv (nimv) will decrease breathing effort in preterm infants immediately after extubation when recovery from rds, as measured by phasic esophageal pressure deflection. furthermore, the investigators plan to evaluate the effects of synchronized nimv on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the s-nimv mode in a newly designed commercially available ventilator device.

Eligibility criteria:
inclusion criteria: preterm infants recovering from respiratory failure with the following criteria were eligible for this study. * gestational age \<32 wks, those who are on invasive mechanical ventilation, recovering from rds, and ready for extubation as judged by the clinical team. * informed consent available. exclusion criteria: • infants with major congenital anomalies involving the cns, lung (i.e. lung hypoplasia, active air leaks) or the heart (asd, vsd allowed), or known neuromuscular disease.

Keywords: premature infants snychronized ventilation non-invasive ventilation rds
blood flow restriction therapy in patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: the purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass and strength in patients that receive blood restriction therapy to patients who receive a placebo.


Eligibility criteria:
inclusion criteria: * asa class i-ii * diagnosed with patellofemoral pain syndrome exclusion criteria: * patients with confirmed radiographic evidence explaining knee pain * legally incompetent or mentally impaired (e.g. minors, alzheimer's subjects, dementia, etc.) * younger than 18 years of age or older than 65 * any patient considered a vulnerable subject * patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension * patients with sickle cell anemia or venous thromboembolism * patients with sickle cell anemia or venous thromboembolism * patients with cancer or lymphectomies * patients with increased intracranial pressure
duodopa home titration using telemedicine: evaluation of use of resources

Conditions: Parkinson's Disease

Summary: the purpose of this study was to evaluate the use of resources during titration of duodopa at home.

telemedicine (tm) offers an alternative titration procedure allowing the start of duodopa infusion at home. the study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (duodopa nurse specialists and the study investigators) and the tm technician, during duodopa infusion at home. data was collected from four (4) clinical centers in sweden. data collection period for each participant started at the decision to administer duodopa treatment (baseline) and ended when the duodopa titration period was complete. post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.

Eligibility criteria:
inclusion criteria: 1. suitable for duodopa treatment in accordance with the swedish summary of product characteristics 2. motivated and confident to test duodopa home titration using tm 3. participants who were able to handle the infusion pump and the tm equipment by themselves or with assistance, as determined by the investigator 4. understood and signed the study informed consent form exclusion criteria: 1. dementia or cognitive decline with mini mental state examination score less than 24 2. ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the investigator 3. contraindications as described in the swedish summary of product characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery 4. other reasons that made the participant unsuitable for home titration using tm, as determined by the investigator

Keywords: lcig parkinson's disease levodopa carbidopa intestinal gel telemedicine
dispensing evaluation of new daily disposable toric soft contact lens.

Conditions: Astigmatism

Summary: the purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.


Eligibility criteria:
inclusion criteria: * the subject must be between 18 and 40 years old. * the subject must have normal eyes. * the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * the subject must read and sign the statement of informed consent and be provided a copy of the form. * the subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00d in each eye. * the subject must manifest -1.25 to -2.00 d of refractive astigmatism in each eye. * the subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye. * the subject must be an adapted wearer of soft toric contact lenses in both eyes. * the subject's best visual acuity (bva) must be better than or equal to 20/25 in each eye. * subjects must already possess a wearable pair of spectacles. exclusion criteria: * ocular or systemic allergies or disease that may interfere with contact lens wear. * systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. * clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. * clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear. * any ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * pregnancy or lactation * any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). * diabetes * strabismus
a study to compare the effect of vildagliptin compared to placebo in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is not being conducted in the united states. vildagliptin is an oral antidiabetic agent. this 12-week clinical study is to evaluate the effect of vildagliptin 50mg qd, 50mg bid or 100mg qd compared to placebo in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * patients who have been placed on dietary therapy/exercise therapy without achievement of glycemic control * outpatients exclusion criteria: * type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes * significant cardiovascular disease * significant diabetic complications other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hemoglobin a1c
tb-lam in the diagnosis of tb

Conditions: HIV Infections; Tuberculosis; Non-Tuberculous Mycobacterial Pneumonia

Summary: tuberculosis (tb) is still the leading cause of death in hiv-infected patients. early diagnosis of tb substantially improves the survival of hiv-infected patients. urine based detection of lipoarabinomannan (lam) provides promising methods for quick diagnosis of tb in hiv-infected patients. however, the sensitivity and specificity of tb-lam is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. here we aimed to evaluate the clinical utility of tb-lam in diagnosis of active tb in hospitalized hiv-infected patients.


Eligibility criteria:
inclusion criteria: * hospitalized hiv-infected patients. * willing to participate into the study. exclusion criteria: * already diagnosed with active tb * received any anti-tuberculosis drugs and/or quinolone for more than 7 days.