Kornimate/medical-research-clean huggingface dataset:
chemotherapy-induced cognitive alterations in recruits with ovarian and breast cancer

Conditions: Cognition Disorders; Polyneuropathies

Summary: neurotoxic phenomena are among the most common and difficult to treat side effects of chemotherapy. the development of chemotherapy induced peripheral neuropathy (cipn) is a well-recognized adverse reaction in the peripheral nervous system. side effects of chemotherapy in the central nervous system, however, particularly changes of cognitive function (in non-medical literature referred to as "chemobrain") are diffuse and difficult to attribute to individual cytostatic drugs. the primary purpose of this study is to assess cognitive function in patients with ovarian and breast cancer before and after systemic chemotherapy with paclitaxel with standardized neuropsychological tests and compare the outcome to patients with benign gynecological tumors and breast cancer without chemotherapy treatment, respectively. secondary parameters include the assessment of olfactory function, total neuropathy score and cytokine profiles.

primary outcome parameter: compound score of standardized neuropsychological test secondary parameters: * olfactory function (sniffin sticks) * total neuropathy score (tns), reduced version (clinical examination, neurography of sural and peroneal nerve) * cytokine profiling from serum samples (elisa) * quality of life (questionnaire) * depression screening (questionnaire) * symptoms of polyneuropathy (questionnaire) * symptoms of cognitive impairment (everyday memory test questionnaire) assessment time points: * baseline (after surgical tumor resection and before chemotherapy) * follow up 1 (3 weeks after last chemotherapy cycle or 21 weeks (control patients)) * follow up 2 (optional; 1 year after chemotherapy completion)

Eligibility criteria:
inclusion criteria: * age * written informed consent * karnofsky index \>70% / ecog \<1 * at least 8 years of education exclusion criteria: * post surgical delirium * major depression * alcohol or drug abuse * anemia \< 8 g/dl * mild cognitive impairment or dementia * previous neurotoxic chemotherapy treatment

Keywords: cognition chemotherapy polyneuropathy paclitaxel cancer chemobrain
effect of diet and exercise in breast cancer survivors

Conditions: Breast Cancer; Obesity

Summary: this study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.


Eligibility criteria:
inclusion criteria: * er/pr/her2neu negative breast cancer * at least 3 months after end of treatment * bmi at least 25 exclusion criteria: * stage iv cancer
optical clearing of the skin in conjunction with laser treatments

Conditions: Port Wine Stain; Nevus of Ota; Tattoos; Scars; Acne; Hypertrichosis; Sebaceous Gland Diseases

Summary: the research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

the researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in 1. decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group. 2. greater optical coherence tomography a non-invasive light based imaging method imaging depth as compared to the control group. 3. greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).

Eligibility criteria:
inclusion criteria: * adult 18 years and older * lesion diagnoses in an area measuring 3 cm2 or more on any body site * apparent good health exclusion criteria: * pregnant women * history of cutaneous photosensitivity * history of photodermatoses

Keywords: sebaceous hyperplasia
long term safety trial to compare insulin treatment with preprandial inhaled human insulin to s.c. insulin aspart both combined with nph in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in oceania. the aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with nph insulin in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * current treatment with any insulin in any regimen * body mass index (bmi) below 38.0 kg/m2 * hba1c below or equal to 13.0% exclusion criteria: * total daily insulin dosage more than 100 iu/day * current acute or chronic pulmonary disease (excluding asthma) * recurrent major hypoglycaemia * proliferative retinopathy or maculopathy requiring acute treatment * smoker * chest x-ray with clinically significant abnormalities
effectiveness of electric stimulation therapy in raynaud's phenomenon

Conditions: Raynaud Phenomenon; Raynaud Disease

Summary: the purpose of this study is to analyze the effects of an intervention with galvanic electrical current on the number of attacks , temperature, pain, peripheral blow flow and upper limb functionality in patients with raynaud's phenomenon in comparison to a control group that will maintain their habitual treatment.

raynaud's phenomenon is a disorder that causes pain and functional limitation in people who suffer it. investigators considerer that the application of an electrotherapy intervention with galvanic current, thanks to its vasodilator action, will produce clinically significant improvements in the number of attacks, temperature and blood flow of patients with raynaud's phenomenon, which can lead to a decrease in pain associated, frequency and severity of ischemic attacks and therefore an improvement in the functionality of the upper limbs. the experimental group will receive an electrotherapy treatment using galvanic current. to apply the treatment, we will place the patient seated, with their hands inside two containers filled with water up to the limit of their nails without touching them. next we will connect the electrodes and apply a galvanic current for 10 minutes, there will be a minute of rest for the patient while we change the polarity of this current and we will apply it another 10 minutes. the intensity of the current depends on the threshold of the patient. the control group will maintain their usual conservative and pharmacological treatment without receiving electrotherapy

Eligibility criteria:
inclusion criteria: * being over 18 years of age. * being diagnosed with primary or secondary raynaud phenomenon according to the criteria established by leroy-medsger. * a history of at least one year of regular attacks of pallor or acral cyanosis caused by exposure to cold and/or stress. * having signed the informed consent document and willingness to participate in the study exclusion criteria: * presence of skin alterations such as stings, scars, ulcers or gangrene in the examined area. * suffering upper limb entrapment syndrome, central nervous system polyneuropathy, hypothyroidism, renal failure, cerebral or cardiac ischemic disease. * history of drug or alcohol abuse. * pregnant or breastfeeding women. * use of vibratory tools. * participants with tumour process.

Keywords: vascular alterations galvanic current pain peripheral blow flow temperature upper limb functionality central sensitization pain catastrophizing. number of attacks
anticipatory & preventive team care (aptcare): at risk patients of family health networks

Conditions: Diabetes; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure; Hypertension

Summary: the university of ottawa and élisabeth bruyère research institute are conducting a study of preventive care for frail patients at risk of functional decline. at risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. in collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. the objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.


Eligibility criteria:
inclusion criteria: * 50 years and over * 'at risk' by having one or more of the following: a. visits to emergency dept within the past 6 months; b. admission to hospital for a medical problem in past 6 months; c. high service use profiles; d. polypharmacy; e. other high risk factors * capable of giving informed consent * able to use the care companion technology exclusion criteria: * cognitive impairment such that they cannot give informed consent * unable or unwilling to use the telehomecare equipment * unlikely to tolerate the intensive intervention * language or cultural barriers * being acutely ill or having an unstable condition on entry to the study
effects of motor cognitive training on functional loss after osteoporotic wrist fractures

Conditions: Osteoporotic Distal Radius Fracture

Summary: the therapy results after distal radius fracture especially of elderly patients are often suboptimal. the central problem results from the inevitable, 3-6-weeks immobilization, which leads to reduction in rom of the wrist, deterioration of muscle strength as well as malfunction of fine motor skills and coordination. currently, there are no adequate proactive strategies to counteract these immobilisation problems. hence the overall aim of our research project is to investigate the therapeutic potential of a motor-cognitive therapy on hand function after distal radius fracture. on the one hand the pilot study should provide information about the level of recruitment rate necessitated for an adequate sample size which allows reliable evidence for the therapy effects. on the other hand we want to evaluate the sensitivity and adequacy of the assessment instruments. the pilot is conceived as a controlled, randomised, longitudinal intervention study over 6 weeks with 3 groups. one experimental group imagine movements and actions without executing them. a second experimental group performs mirror training, in which visual feedback through a mirror activates additionally the contralateral hemisphere. the control group receives therapy as usual. there are three key domains to be analysed: function (prwe), impairment (rom, strength) and participation in social life/life quality (dash, eq5d).


Eligibility criteria:
inclusion criteria: * wrist fracture * age 65 and older exclusion criteria: * unstable medical conditions which preclude surgical intervention (asa 5) * patients who do not live independently (nursing home) * patients with an open fracture * associated soft tissue or skeletal injury to the same limb * cognitive impairment (6cit \< 10)

Keywords: osteoporosis wrist fracture mental practice mirror therapy immobilization elderly
use of radiographic contrast to detect dental caries

Conditions: Dental Caries

Summary: the proposed test is intended to enable dentists to differentiate between cavitated and non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces). in these areas, dentists cannot visually inspect for caries, and currently bitewing x-rays (bws) only correctly detect the presence of enamel decay 15-25% of the time. this low sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns, pain, root canals, and possible later loss of teeth. hypothesis: use of radiographic contrast on teeth will increase the accuracy of detection of early cavitation from 58% to 90%.

tooth sites will be recorded by tooth number, type of surface (mesial, distal,occlusal), cavitated, non-cavitated, healthy. radiographs will similarly be scored.although contrast agents are classified as drugs this is not a study of drug properties or effect on cells since the properties of the agent are already well know and its safety record well established. this study will be recording the radiopacity of the contrast agent on healthy tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. the outcome for each surface type will be presence or absence of a radiopacity on a radiograph which will be made at the one and only visit for each study subject. the radiograph contains the data from the intervention (placement of contrast agent) and the outcome will be assessed some weeks later after the completion of the data collection.

Eligibility criteria:
inclusion criteria: * must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual inspection. * the occlusal plane should be normal so that the interproximal contact regions are normal. * english or spanish speaker. exclusion criteria: * pregnant women * a person who has participated in a similar study involving dental radiography within the last 12 months. * fillings must not be present in the regions of interest.

Keywords: dental caries radiography, dental contrast media tooth
effect of roflumilast on lung function in chronic obstructive pulmonary disease (copd) patients treated with salmeterol: the eos study (by217/m2-127)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (copd) during concomitant administration of salmeterol. the study duration will last up to 28 weeks. the study will provide further data on safety and tolerability of roflumilast.


Eligibility criteria:
main inclusion criteria: * history of copd for at least 12 months prior to baseline visit * fev1/fvc ratio (post-bronchodilator) ≤ 70% * fev1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted main exclusion criteria: * copd exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

Keywords: roflumilast salmeterol copd chronic obstructive pulmonary disease
study of tibial shaft fracture fixation: intramedullary nailing comparing with dynamic compression plate

Conditions: Tibial Shaft Fracture

Summary: the purpose of this study is to determine which surgical approach is better for treatment of tibial shaft fracture

tibial fracture is more common fracture. we aimed to compare unreamed intramedullary nailing (utn) and dynamic compression plate (dcp) with regard to fracture healing and complications in patients with closed tibial shaft fractures.

Eligibility criteria:
inclusion criteria: * patient with tibial shaft fracture exclusion criteria: * nothing

Keywords: close fracture tibia unreamed intramedullary nailing dynamic compression plate
a phase 2 study of bnc210 for the acute treatment of social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to assess the effects of an acute dose of bnc210 compared to placebo on reducing anxiety provoked by a speaking challenge and measured using the subjective units of distress scale (suds) in patients with social anxiety disorder (sad).

this is a randomized, double-blind, placebo-controlled, 3-arm, parallel-group, multi-center study. participants will attend a screening visit to confirm eligibility and then return to the clinic within 14 days to be randomized into the study. randomized participants will receive a single dose of their allocated study intervention (225 mg bnc210, 675 mg bnc210 or placebo) and approximately 1 hour later participate in a speaking challenge. after 1 week, a safety follow-up assessment will be conducted by phone/video conference.

Eligibility criteria:
inclusion criteria: * participant has a current diagnosis of social anxiety disorder (sad) as defined in dsm-5 and confirmed by structured clinical interview for dsm-5 disorders - clinical trials version (scid-5-ct). * liebowitz social anxiety scale (lsas) total score of ≥70 * suitable contraception use in line with protocol requirements * ability to swallow tablets exclusion criteria: * history of schizophrenia, bipolar disorder, or psychotic disorders, or has a current clinically predominant diagnosis of any other axis i disorder, other than sad * hamilton rating scale for depression (ham-d) score of ≥18 * moderate or severe alcohol-use disorder, or any other substance-use disorder (any severity) in the past 12 months * use of psychotropic medications within 30 days of screening. daily use of benzodiazepines within 90 days of screening. * previous participation in a study that involved a speaking challenge. * any clinically significant medical history or findings as determined by the investigator that could interfere with the objectives of the study or put the participant at risk
a registered cohort study on fshd1

Conditions: Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)

Summary: the data to be collected is intended to help healthcare providers make important medical and financial decisions concerning fshd1, through an enhanced understanding of the prevalence, progression and natural history of fshd1.

the china fshd1 patient registry is a nationwide, population-based, non-interventional, observational cohort clinical study of all age groups of genetically-confirmed fshd1 patients from families (with at least 1 affected member), collecting data retrospectively at study entry and prospectively during follow up. the data to be collected is intended to help healthcare providers make important medical and financial decisions concerning fshd1, through an enhanced understanding of the prevalence, progression and natural history of fshd1.

Eligibility criteria:
inclusion criteria: * male or female subjects of all ages at baseline * subjects, with or without symptoms, with fshd1 genetic confirmation through pfge-based southern blotting * unrelated healthy controls exclusion criteria: * decline to participate * other neuromuscular disease (such as limb-girdle muscular dystrophy or myotonic dystrophy) * serious systemic illness (such as heart, liver, kidney disease or major mental illness)
a study to evaluate the efficacy and safety of betahistine mesilate in the treatment of patients with vertigo caused by cerebral infarction in posterior circulation

Conditions: Vertigo

Summary: the purpose of this study is to determine the efficacy and safety of betahistine mesilate in the treatment of patients with vertigo caused by cerebral infarction in posterior circulation.


Eligibility criteria:
inclusion criteria: 1. patients that have a clinical diagnosis of posterior circulation infarction and vertigo occurring within 1 month after the infarction.

Keywords: vertigo posterior circulation infarction
safety and immunogenicity study of split influenza virus vaccine in different age groups

Conditions: Influenza

Summary: the purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (hi) antibody positive rate, geometric mean titer (gmt) of three brands split influenza virus vaccine in different population.

observational objectives: to describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday. to describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the package insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.

Eligibility criteria:
inclusion criteria: * participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years） * eligible participants were generally healthy or had stable chronic medical conditions (for older adults only) exclusion criteria: * history of allergic reaction to any component of the study vaccines or previous influenza vaccine * history of systemic hypersensitivity to hens' eggs * history of guillain barré syndrome following administration of any influenza vaccine * any immunodeficient or immunocompromised conditions * receipt of cytotoxic or immunosuppressive drugs within the past 6 months * receipt of blood-derived product within the past 3 months * receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination * receipt of non-study 2010-2011 seasonal tiv * participation in any other study with a non-approved drug during the study * acute febrile disease and other self-limiting illness were the temporary exclusion criteria
nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease

Conditions: COPD Exacerbation Acute

Summary: the elvis study compares the nasal high-flow to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease.

the elvis study is a prospective, randomized, multi-centre open label trial following a non-inferiority design to compare the nasal high-flow (nhf) to non-invasive ventilation (niv) in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease. accoring to the randomization the patient is treated with nhf or niv until discharge. a change of device is possible, if switch criteria are fulfiled or need for intubation criteria are met before 72h (timepoint for primary endpoint).

Eligibility criteria:
inclusion criteria: 1. acute hypercapnic exacerbation of chronic obstructive pulmonary disease with ph \< 7.35 2. pco2 \> 45mmhg 3. age ≥ 18 years 4. written informed consent exclusion criteria: 1. immediate need for intubation (acc. to intubation criteria in this protocol) 2. ph \< 7.15 3. bmi ≥ 35 kg/m² 4. established home-niv or home-cpap 5. end-stage disease with dni/dnr order 6. diseases that could influence the primary endpoint: e.g. acute heart infarction, cardiogenic lung edema, acute and massive lung embolism (hypertensive), chronic dialysis with metabolic acidosis, unstable rib fracture influencing ventilation, injury to the face prohibiting use of a face mask 7. acute disease that precludes participation in the trial 8. tracheotomized patients 9. psychological/mental or other inabilities to supply required informed consent 10. participation in other interventional trials 11. suspected lack of compliance

Keywords: nasal high-flow non-invasive ventilation
a study of ro5095932 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2

Summary: this randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of ro5095932 in patients with type 2 diabetes mellitus. patients will be randomized to receive either ro5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age * females who are either surgically sterile or post-menopausal * type 2 diabetes treated with a stable dose of metformin * bmi between 25-39kg/m2 * hba1c between 7 and 10% * fasting plasma glucose between 7 and 13.3mmol/l exclusion criteria: * history of clinically significant cardiovascular disease * history of clinically significant hepatic or renal disease or impairment * recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or dpp-iv inhibitors