Kornimate/medical-research-clean huggingface dataset:
pilot study in vivo confocal microscopy probe for cervical precancer

Conditions: Precancerous Condition; Cervical Cancer

Summary: the goal of this proposal is to determine whether a hand-held confocal microscopy probe may perform better than standard methods in detecting cancer or pre-cancerous abnormalities of the cervix. the confocal probe will provide invivo histopathology-like images of cell morphology and three-dimensional tissue architecture non-invasively in real time.

all subjects will undergo standard management (colposcopy) for their cervical lesion as scheduled. for cervical sites suspicious of dysplasia, acriflavine hydrochloride 0.05% solution will be applied topically, then rinsed with saline prior to in vivo confocal imaging with the hand-held probe. following that, a biopsy of the suspicious site will be performed irrespective of the confocal microscopy finding. a biopsy of the normal site will be taken for research purposes. the confocal probe imaging will not alter where and how the biopsies will be taken (no change to size of biopsy or location on cervix). the procedure will add approximately 15 minutes to the duration of the standard outpatient procedure. during each examination, the anatomical location of all tissue areas in question will be recorded using the clock-position nomenclature system. some normal areas will be also localized and recorded as control. digital images will be recorded in the computer.

Eligibility criteria:
inclusion criteria: * indicate understanding of the study * provide informed consent to participate * 18 years old or older * not pregnant and have negative urine pregnancy test * be schedule for colposcopy \& biopsy at the vancouver general hospital women's clinic exclusion criteria: * they are breast-feeding * they had an operation to remove their cervix

Keywords: cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 adenocarcinoma in situ
virtual reality intradialysis: last vs. first part of the session

Conditions: End Stage Renal Disease on Dialysis; Hemodialysis Complication

Summary: the main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session. the secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. we will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.

participants will be randomized into one of two groups. the first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. the second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. the exercise program will last for 9 months. the virtual reality exercise will undertake up to 30 minutes of exercise. after warming up, participants will play to an adapted 'treasure hunt' game. their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. the aim of the game will be to achieve the higher possible score. they will move their legs to pick up coins and to avoid bombs. an adapted kinect technology will be used for game development. the exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. two more games will be introduced progressively for patients not to get bored, 'air hockey' and 'simon'.

Eligibility criteria:
inclusion criteria: * at least 3 months in hemodialysis treatment * clinically stable exclusion criteria: * recent cardiac events (less than 3 months) * unable to exercise

Keywords: exercise virtual reality physical function health-related quality of life hemodynamic instability
adverse drug reactions in older subjects

Conditions: Dementia

Summary: objective: to identify risk factors for the occurrence of adverse drug reactions (adrs) based on geriatric evaluation. design: longitudinal prospective study from may 2010 to november 2011. setting: dedicated acute geriatric care unit specializing in the management of patients with dementia at the university hospital of reims, france. measurements: sociodemographic variables and comprehensive geriatric assessment were recorded. occurrence of adrs was noted. risk factors for adr were identified by multivariate logistic regression.

introduction: adverse drug reactions (adrs) are frequent among older subjects, and are actually avoidable in up to 60% of cases. there are few studies identifying the risk factors for adrs based on comprehensive geriatric assessment in older subjects with dementia, although better identification of patients at risk could help to target patients at risk for increased morbidity and mortality due to adrs with a view to taking appropriate preventive measures. objective: to identify risk factors for the occurrence of adverse drug reactions (adrs) based on geriatric evaluation. design: longitudinal prospective study from may 2010 to november 2011. setting: dedicated acute geriatric care unit specializing in the management of patients with dementia syndrome (alzheimer disease or related syndromes) at the university hospital of reims, france. participants: older patients with dementia syndrome (alzheimer disease or related syndromes). measurements: sociodemographic variables and comprehensive geriatric assessment were recorded. occurrence of adrs was noted. risk factors for adr were identified by multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * diagnosis of dementia syndrome * unplanned hospitalisation between may 2010 and november 2011 exclusion criteria: - no exclusion criteria

Keywords: dementia alzheimer dementia
efficacy of costal mobilization techniques and manual diaphragm release technique in patients copd

Conditions: Copd; Chest Disorders; Diaphragmatic Disorder

Summary: to evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease

study will be a controlled clinical trial in which participants will be randomized into 2 groups: group a (costal mobilization techniques and manual diaphragm release technique), group b (manual diaphragm release technique). after the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. the evaluation will be performed through optoelectronic plethysmography , pollar, ultrasound and 6-minutes walk test.

Eligibility criteria:
inclusion criteria: * diagnosis of copd (spirometry with fev1 \<80% and fev1 / fvc \<0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks. exclusion criteria: * patients with rheumatic or orthopedic diseases; * deformities / abnormalities in the spine that compromise the mechanics of the respiratory system; * rib fracture for less than 1 year; * respiratory co-morbidities; * history of thoracic or abdominal surgery for less than 1 year; * osteoporosis and imc \> 30kg / m²
feasibility of a non-invasive, trans-abdominal, low cost fetal oximetry probe on pregnant human subjects

Conditions: Pregnancy, Abdominal

Summary: three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate. we want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen. current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.

the study subject will have a brief trans-abdominal ultrasound examination. 3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. no probes will be placed into the vagina. it is anticipated that 6 months will be required to recruit, consent and study 25 participants.

Eligibility criteria:
inclusion criteria: * greater than 36 weeks pregnant * singleton fetus exclusion criteria: * prisoners

Keywords: pregnancy fetal monitoring fetal oximetry fetal heart rate pulse oximetry near infrared spectroscopy
post-marketing use of ct-p13 (infliximab) for standard of care treatment of rheumatoid diseases who are naïve to biologics or switched from remicade

Conditions: Rheumatoid Diseases; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: to assess persistence of ct-p13 in patients with rheumatoid diseases (rheumatoid arthritis \[ra\], ankylosing spondylitis \[as\], and psoriatic arthritis \[psa\]) who are naïve to biologics or are switching from stable remicade to ct-p13. the main objectives of the study are: * to evaluate real-life drug persistence in ra, as, and psa patients who are either initiated with ct-p13 as their first biologic, or who are switched from stable remicade * to characterise the patient populations and drug usage patterns of ra, as, and psa patients who are either initiated with ct-p13 as their first biologic, or who are switched from stable remicade * to assess the safety of ct-p13 in ra, as, and psa patients who are either initiated with ct-p13 as their first biologic, or who are switched from stable remicade for up to 2 years

the study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in guidelines for good pharmacoepidemiology practices (gpp), good epidemiological practice (gep), good practices for outcomes research, international ethical guidelines for epidemiological research, european medicines agency (ema) european network of centres for pharmacoepidemiology and pharmacovigilance (encepp) guide on methodological standards in pharmacoepidemiology, and fda guidance for industry. data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. data sources will be validated. the source data will consist of medical records, physician questionnaires, and patient questionnaires. data for the study will be entered into an electronic data capture system. questionnaires will be completed on electronic tablets. the study is a one year enrollment period with a two year follow-up period. the study plans to enroll patients throughout canada and europe.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years old at the time of enrollment 2. patients who are prescribed ct-p13 or remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (smpc and product monograph) as determined by the investigator exclusion criteria: 1. any reported contraindications for inflectra according to the smpc or product monograph 2. known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment

Keywords: ct-p13 inflectra remsima remicade infliximab observational follow-up safety
a study to evaluate the product performance of the purevision®2 high definition (hd) contact lens

Conditions: Myopia

Summary: the objective of this study is to evaluate the product performance of purevision2 hd contact lenses.


Eligibility criteria:
inclusion criteria: * have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings * subjects must be myopic or hyperopic and require lens correction in each eye * subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years. exclusion criteria: * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * any systemic disease affecting ocular health. * using any systemic or topical medications that will affect ocular physiology or lens performance. * allergic to any component in the biotrue multi-purpose solution
palliative care in spinal muscular atrophy (sma) 1

Conditions: Spinal Muscular Atrophy 1

Summary: the purpose of this study is to evaluate the quality of supportive and palliative care for sma type 1 patients.

spinal muscular atrophy type i (sma i) is the most severe form of sma. it presents in infancy and death occurs by 2 years. there is actually no curative treatment for this pathology. support and help must be provided from the time of presentation till death and usually this period is quite short, about a couple of months. variations in medical practice have be seen, depending on the medical experience and sometimes coupled with differences in family resources and values. the aim of the study is to evaluate the needs of the patients and their families, the medical practices, and to describe a cohort of sma type 1 patients with the natural history of this disease. for this, a follow-up diary will be done, and this diary will be completed by the families and the different practitioners working with the patient. will be noted in it : physical signs, all therapeutic choices and actions, evaluation of the pain and treatments. a special part of this follow-up diary will be completed by the medical doctors, after the death of the patient, with all the medication used at time of death and the conditions of the death. one year after the death of the patient, a questionnaire will be proposed to the parents of the child by a psychologist. this questionnaire will estimate the benefice of the follow-up diary, and the improvements to give in the diagnostic strategies, recommendations for assessment and monitoring, and therapeutic interventions in sma type 1.

Eligibility criteria:
inclusion criteria: * sma type 1 under 1 an * genetic confirmation exclusion criteria: * no genetic confirmation * sma type 1 over 1 year

Keywords: spinal muscular atrophy (sma) type 1 supportive care palliative care
the safety,preliminary pharmacodynamics and pharmacokinetics study of rexenatide-4 in chinese type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this research is randomized, controlled trial. 36 chinese subjects with type 2 diabetes mellitus will take part in the trial. subjects will randomly enter into one of three groups, administration daily twice, the period of is 84 days treatment. subjects should be in hospital for pharmacokinetic studies in 1 d\~ 8d, 30 d (if necessary)and 84 d, during 9 d \~ 83 d outpatient follow-up.


Eligibility criteria:
inclusion criteria: 1. 18 \~ 75 years with t2dm in china; 2. hba1c of 7% to 13%; 3. negative pregnancy test in females, all subjects have no family planning during the test and after the end within 3 months. exclusion criteria: 1. hbsag, hcv, hiv and syphilis test was positive; 2. any time fbg \ 14.0 mmol / l in the morning; 3. renal function: egfr \<60 ml / min ; 4. tg\> 5mmol / l; 5. pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases; 6. ischemic heart disease, heart failure, stroke or peripheral vascular disease; 7. pregnancy and breast-feeding women; 8. patients requiring insulin treatment; 9. have medical history of hypoglycemia; 10. have a clear history of allergic patients; 11. patients addicted to alcohol and tobacco.

Keywords: diabetes rre-4 exenatide metformin cspc zhongqi
a home telemonitoring system for wearable fetal-ecg and ehg acquisition during pregnancy

Conditions: Uterine Contractions; Prolonged; Fetal Heart Rate or Rhythm Abnormality Affecting Fetus; Pregnancy Related; Home Range

Summary: the goal of this observational is to compare in describing fetal health conditions. the main questions it aims to answer are: * fetal electrocardiogram (fetal heart rate and fetal rhythm) * electrohysterography (uterine contractions). participants will wear wearable devices and ctg equipment for monitoring for 30 minutes.if there is a comparison group: researchers will compare clinical ctg equipment to see if this wearable device.

the investigators put the patch of the wearable device on the abdomen of the pregnant woman and continued the test for thirty minutes.

Eligibility criteria:
inclusion criteria: * pregnant women with a gestational cycle greater than 36 weeks exclusion criteria: * male * pregnant women with a gestational cycle less than 36 weeks

Keywords: fecg ehg
home balance pilot for fall reduction in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: there is a growing body of evidence demonstrating that older adults with copd have important problems with their balance and a high incidence of falls compared to those of a similar age. this research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with copd.

chronic obstructive pulmonary disease (copd) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in canada. there is a growing body of evidence demonstrating that older adults with copd have important problems with their balance and a high incidence of falls compared to those of a similar age. this research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with copd. the primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with copd in terms of recruitment, retention and adherence. the secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability. thirty-five older adults with copd will be recruited from respirology clinics at west park healthcare centre (toronto) and the firestone institute for respiratory health (hamilton) to participate in a single-group, non-randomized clinical trial. eligible participants will be enrolled in a 6-month balance home exercise intervention. the home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of copd; * age ≥ 60 yrs; * a history of 1 or more falls in the previous year; * ability to provide written informed consent. exclusion criteria: * inability to communicate in english; * history of significant cardiovascular disease; * marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity; * severe cognitive impairment; * evidence of a condition that severely limits mobility and may jeopardize safety; * completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.

Keywords: balance falls exercise copd
a survival observational study in patients with advanced iiib-iv squamous cell lung cancer receiving pd-1 combination with chemotherapy

Conditions: Lung Squamous Cell Carcinoma Stage IV

Summary: this is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management. in the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (ehr) of each research center. the clinical information will be based on the actual medical records of the cases. after the retrospective study time (june 30, 2020), patients will be followed for one-year and two-year survival. clinical treatment and management will be based on local clinical practices and regulations. this study will record the actual diagnosis and treatment, and will not interfere with any clinical decision. after subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. all patients receiving pd-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. at the end of study, investigator will check up on the conditions of patients who withdraw from the study.


Eligibility criteria:
inclusion criteria: 1. men and woman, aged over 18 2. cytology or histologically confirmed squamous cell lung cancer 3. advanced squamous cell lung cancer, stage iiib to iv according to ajcc staging (version 8) 4. patients receiving approved pd-1 mab in combination with chemotherapy according to their condition 5. patients receiving pd-1 mab in combination with chemotherapy for at least one cycle (21 days) 6. have imaging results with measurable tumor 2 weeks before receiving pd-1 mab in combination with chemotherapy 7. able to understand and comply with the requirements of the consent and voluntarily participate in the study exclusion criteria: 1. patients participating in other clinical studies 2. severe medical data missing 3. unable to understand the purpose of the study or not agree with the requirement of the study 4. malignancies other than squamous cell lung cancer, history of malignancies 5. unsuitable for the study according to investigator
acute cough study in children

Conditions: Common Cold; Infections, Upper Respiratory Tract

Summary: 15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

in light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.

Eligibility criteria:
inclusion criteria: male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute urti characterized by: * onset of cold/urti symptoms occurring no more than 10 days prior to visit 1; * at least 5 coughs during the second 30-minute period of the 60-minute baseline period. general good health, aside from a common cold, and has no contraindications to the study or rescue medication exclusion criteria: * acute, subchronic, or chronic cough due to any other condition other than a common cold history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease

Keywords: randomized parallel double-blind placebo-controlled cough efficacy safety dextromethorphan