Kornimate/medical-research-clean huggingface dataset:
impact of geriatrician interventions on chemotherapy delivery in vulnerable elderly oncology patients

Conditions: Breast Cancer; Lung Cancer; Ovarian Cancer; Prostate Cancer; Bladder Cancer; Gastrointestinal Cancer

Summary: this is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (cga), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (rdi).

this randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by rdi of at least 85%, in a cohort of vulnerable \[≥1 deficit identified at cga and/or ≥1 comorbidity grade 3-4 as defined by cumulative illness rating scale for geriatrics (cirs-g)\] elderly cancer patients with early stage or advanced solid organ malignancies. patients will be randomized using a 2:1 allocation to arm a: routine oncological care plus geriatric intervention or arm b: routine oncological care

Eligibility criteria:
inclusion criteria: 1. any solid tumors 2. either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting 3. absence of symptomatic central nervous system (cns) metastases 4. eastern cooperative oncology group (ecog) performance status 0-2 5. estimated life expectancy of ≥ 12 weeks 6. at least 1 deficit identified on cga at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by cirs-g 7. written informed consent in according to international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use/good clinical practice (ich/gcp), and national/local ethics regulations 8. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule exclusion criteria: 1. age ≤ 69 years 2. any patients who did not meet the inclusion criteria

Keywords: breast cancer lung cancer gastrointestinal cancer ovarian cancer prostate cancer bladder cancer
hybrid: hydrogen breath test in lactose digestion

Conditions: Lactose Intolerance

Summary: the purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.


Eligibility criteria:
inclusion criteria: bmi between 18.5 and 24.9 kg/m2 inclusive lactose intolerant the following criteria need to be checked at visit 2: * lactose intolerance confirmed by positive hydrogen breath test (hbt) (i.e. if there are two or more samples with hydrogen level \> 20 ppm increase compared to baseline sample between 90 mins and 240 min sampling time point). * at least one sample with hydrogen level \> 20 ppm increase compared to baseline between 90 mins and 180 mins sampling time point. exclusion criteria: history of gastrointestinal disorders current illness which could interfere with the study (e.g. diarrhea, regurgitation) any history of cow's milk protein allergy or known allergy to galacto-oligosaccharides any current participation or within 8 weeks of study start, in any other study involving investigational or marketed products, any medical procedures, or any surgical methods. any antibiotic, laxative or colonic cleansing treatments within 4 weeks of study start any administration of probiotic in the 1 week prior to study start investigator's uncertainty about willingness or ability of subject to comply with protocol requirements the following criteria need to be checked at visit 2: * level of hydrogen \> 20 ppm in the baseline breath sample. * an early peak of hydrogen (i.e. hydrogen level \> 20 ppm increase compared to baseline value) in the first 60 minutes after ingestion of the study products.
comparison by neuromonitoring of two techniques of tracheal intubation in patients with unstable cervical spine

Conditions: Spinal Injuries

Summary: patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. commonly, the management of the tracheal intubation is performed by a fiberoptic technique. however, changes in equipment availability and quality may challenge the fiberoptic intubation technique. the investigators wish to compare the tracheal intubations performed with the airtraq in comparison with the fiberscopic technique.

patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique). however, changes in equipment availability and quality may challenge the fiberoptic intubation technique. we wish to compare the tracheal intubations performed with the airtraq in comparison with the fiberscopic technique. primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases: 1. basal potential (bm): neuromonitoring while the patient is anesthetized, no movements 2. ventilation potential (vm): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed 3. intubation potential (ip): neuromonitoring while the patient is being intubated with one of the two randomized devices 4. post intubation (pi): neuromonitoring after the patient has been intubated 5. post positioning (pp): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Eligibility criteria:
inclusion criteria: * unstable cervical spine due to a cervical vertebra fracture * american society of anesthesia classification 1-3 * bmi \< 30 kg/m2 * patients necessitating a general anesthesia for surgery exclusion criteria: * patient refusal * asa \>3 * mouth opening \< 15mm * patients with known history of previous orotracheal tumor surgery

Keywords: intubation difficult airway fiberscopy airtraq general anesthesia
patients with pulmonary hypertension or interstitial lung disease at altitude - effect of oxygen on exercise performance

Conditions: Precapillary Pulmonary Hypertension; Interstitial Lung Disease

Summary: the purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with pulmonary hypertension or with interstitial lung disease.

patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. outcomes will be assessed at low altitude (zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (st. moritz salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). the order of stays at the different altitudes and of the treatments will be randomized.

Eligibility criteria:
inclusion criteria: * precapillary pulmonary hypertension, or interstitial lung disease. * new york heart association class 2-3. * residence at low altitude (\<800m). exclusion criteria: * unstable or exacerbated condition * very severe pulmonary hypertension or interstitial lung disease, new york heart association class 4 * requirement for oxygen therapy at low altitude residence * hypoventilation * more than mild or unstable cardiovascular disease * use of drugs that affect respiratory center drive * internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test. * previous intolerance to moderate altitude (\<2600m). * exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study. * pregnant or nursing patients

Keywords: pulmonary hypertension interstitial lung disease pulmonary fibrosis
risk of dry eye post different surgeries for blepharoptosis repair

Conditions: Blepharoptosis

Summary: blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. acquired blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. treatment is surgical and can be performed by three common procedures - levator advancement, müller's muscle-conjunctival resection procedure and white line advancement. a number of reports inspected the possibility that blepharoptosis repair procedures may cause deterioration in dry eye status. the investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.


Eligibility criteria:
inclusion criteria: * ptosis which indicate surgical repair * the ptosis must be suitable for repair in any of the procedures exclusion criteria: * systemic disease which may cause ocular surface disease (eg sjogren disease) * previous orbital or eyelid surgery * significantly dry eyes
zinc supplements in lowering cadmium levels in smokers

Conditions: Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder

Summary: rationale: zinc supplements may lower cadmium levels in smokers and may help prevent dna damage. purpose: this clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.

objectives: * determine whether zinc supplements reduce cadmium levels in smokers. * measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits. * determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with visivite smoker's formula. * determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair. * determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair. outline: this is an open-label, nonrandomized study. patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity. blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (msh2, msh6, msh3, mlh1, and pms2), levels of messenger rna by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis. after completion of study therapy, patients are followed for 5 weeks.

Eligibility criteria:
disease characteristics: * currently smoking ≥ 1 pack (20 cigarettes) per day * baseline cadmium level ≥ 0.5 μg/l patient characteristics: * negative pregnancy test * fertile patients must use effective contraception * no known gastrointestinal upset due to zinc vitamins or lozenges prior concurrent therapy: * at least 2 weeks since prior and no other concurrent vitamins and zinc supplements

Keywords: renal cell carcinoma bladder cancer cervical cancer esophageal cancer gastric cancer adult acute myeloid leukemia pancreatic cancer hypopharyngeal cancer lip and oral cavity cancer laryngeal cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavity cancer non-small cell lung cancer small cell lung cancer adult primary liver cancer tongue cancer tobacco use disorder
automated structured education based on an app and ai in chinese patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: in recent years, more and more attention has been paid to diabetes self-management. glycemic control and self-management skills of patients with type 1 diabetes (t1dm) in china are poor. artificial intelligence (ai) and the internet offer a new way to improve the self-management skills of patients with chronic diseases. few studies have combined ai technology with structured education intervention of type 1 diabetes. this study is innovative in that it compares the effectiveness of smartphone app between usual care, as well as automatic and individualized app education and standardized app education to explore whether the individualized treatment advocated by the latest guideline will bring any additional benefit to t1dm patients. the ultimate goal is to provide an effective and convenient approach for glycemic control of type 1 diabetes and reduce related disease burden in china.

this is a single-blinded, 1:1 paralleled group cluster randomized controlled trial (rct). the intervention will last for 24 weeks. the laboratory staff who test the hba1c level, the outcome assessor who collects the blood glucose data, and the statisticians will be blinded to the treatment allocation. sample size estimation: we propose to enroll 138 patients with type 1 diabetes (t1dm) by considering withdrawals, 69 in the smartphone app groups and 69 in the routine care group. sample size estimation is based on hypothesized changes in the primary outcome hba1c. in order to ensure high quality data, two staff are responsible for the input of original data into the database to check and confirm the accuracy. when the data entered by two staff independently, the auxiliary staff decides which data to use. data analysis will be conducted under the intention-to-treat principle by including all the randomized patients in the data analysis. missing data will be filled in with multiple imputation method. any substantial difference in baseline characteristics will be adjusted with mixed-model regression analysis. sensitivity analysis will be conducted by using per-protocol data by excluding those patients who drop out of the rct.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with type 1 diabetes according to the 1999 world health organization report * insulin dependence from disease onset * aged 18-50 years * with a disease duration over 6 months * with a hba1c level over 7% * treated t1dm with multiple daily injections or insulin pump * individuals who own smartphone and are capable of using wechat or apps exclusion criteria: * age below 18 years or above 50 years * being pregnant * with mental disorders * have any other condition or disease that may hamper from compliance with the protocol or complication of the trial * already using a smartphone app for managing diabetes * having chronic complications including diabetic retinopathy, diabetic nephropathy or diabetic foot, diabetic neuropathy
effectiveness of ultra-low-dose chest ct with ai based denoising solution

Conditions: Lung Diseases

Summary: the main objective of the study is to evaluate the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of uldct coupling with innovative vendor-neutral ct denoising solution based on deep learning technology.

considering lung cancer-related public health challenges, a reliable lung cancer screening method for high-risk cohorts in mongolia is needed. thus, our study aims to assess the detection rate of pulmonary conditions, percentage of ionizing radiation dose reduction, and state of image quality of uldct coupling with artificial intelligence based ct denoising technique among various patient groups.

Eligibility criteria:
inclusion criteria: * patients aged over 18-year-old * patients undergoing ct chest for all purpose exclusion criteria: * age less than 18 years * any suspicion of pregnancy * history of thoracic surgery or placement of the metallic device in the thorax * an inability to hold respiration during ct

Keywords: computed tomography artificial intelligence denoising technique ultra-low-dose computed tomography
conduct of nasal high flow oxygen in acute respiratory failure

Conditions: Acute Respiratory Failure With Hypoxia; Hypoxemia

Summary: although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

nasal high flow oxygen therapy is increasingly used as a first-line treatment for hypoxemic acute respiratory failure, because of its remarkable tolerance (in comparison with niv) and its physiological effects (nasopharyngeal dead space washout, positive end-expiratory pressure effect with possible alveolar recruitment, better matching with the patient's inspiratory flow, more reliable and adjustable fio2); that together contribute to a reduction in respiratory workload and better oxygenation. although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there are no data (and even less recommendations) on how to best conduct this technique, including its initiation and its weaning periods. because different approaches exist among clinicians, investigators believe that a multicenter observational study that would collect data regarding the different ways high flow is conducted in patients with acute respiratory failure is necessary before performing an interventional study that would test and compare different strategies in order to answer the question: what are the best strategies (in terms of flow and fio2 settings) to initiate and to wean high-flow oxygen therapy in patients with acute respiratory failure? investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

Eligibility criteria:
inclusion criteria: * patients aged 18 or older * admitted to the intensive care unit (icu) or to the intermediate care for acute hypoxemic respiratory failure (whatever the cause) * treated with nasal high flow oxygen therapy * with a minimal fio2 of fio2≥50% and a gas flow ≥40 l/min * anticipated duration of nasal high flow therapy greater or equal to 24 hours non-inclusion criteria: * prophylactic, post-extubation nasal high flow therapy * palliative nasal high flow therapy (do-not-resuscitate order) exclusion criteria - nasal high flow therapy administered for less than 24 hours

Keywords: high flow nasal oxygen acute hypoxemic respiratory failure adults intensive care unit
a pilot study on the use of a sensory panel to assess comfort between three different contact lenses

Conditions: Dry Eye Syndromes

Summary: as new contact lens products continue to be developed and improved, it's becoming harder for some individuals to tell whether one product is different from another. in addition, not everyone has the same level of sensitivity of their eyes, making it difficult for these judgments to be made. the purpose of this study is to explore the idea of using a pre-determined "expert panel" of individuals who are able to tell differences between contact lenses based on their comfort.

as technology continues to advance, contact lenses and lens care products are becoming harder to differentiate. in addition, assessing comfort in clinical trials is complicated, with full-masking behind hard to achieve and the psychology of the participant having unknown impact on the results. while the development of a reliable system to assess comfort would be beneficial for the research and development of new products, the use of a "sensory panel" itself may also lead to a better understanding of the drivers of discomfort at the end of the day. the objective of the study is to explore the use of a sensory panel, defined as individuals who have a good correlation between subjective and objective measures of discomfort, at rating the comfort of various contact lenses. the hypothesis is that in the "discriminative" group, the matrix of paired comparisons (between lens dissimilarity) is related to the ranked comfort of the lenses, while for the "poorly discriminative" group, the matrix of the dissimilarities will be random. an additional hypothesis is that the "discriminative" group will be less random than the entire group.

Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer; * has read and signed an information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * is an adapted soft contact lens wearer; * has a contact lens prescription between +4.00 to -6.00d; * has astigmatism \<= 1.00d; * has vision of 20/40 or better in both eyes when wearing contact lenses exclusion criteria: * is participating in any concurrent clinical or research study; * has any known active ocular disease and/or infection; * has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * has known sensitivity to the diagnostic pharmaceuticals to be used in the study; * is pregnant, lactating or planning a pregnancy at the time of enrolment, determined verbally; * is aphakic; * has undergone refractive surgery; * is an employee of the centre for contact lens research; * has anisometropia of \>=1.00d * has a difference in comfort of 20 (on a 0-100 scale) between eyes when not wearing contact lenses.
a trial to evaluate bms-298585 as monotherapy in subjects with type 2 diabetes who have inadequate glycemic control

Conditions: Diabetes, Type 2

Summary: to determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of bms-298585 in drug naive subjects with type 2 diabetes as an adjunct to diet and exercise.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * drug naive * hba1c \>= 7.0% and \<= 10.0% * body mass index \<= 41 kg/m2 * serum tg \<= 600 mg/dl exclusion criteria: * symptomatic type 2 diabetes * history of bladder cancer * history of myocardial infarction (mi), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attach (tia), or cerebrovascular accident (cva) within 6 months, congestive heart failure (nyha class ii and iv), uncontrolled hypertension, history of renal disease, peripheral vascular disease (pvd), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.