Kornimate/medical-research-clean huggingface dataset:
holistic wellbeing in copd: communication about sexuality (cosy)

Conditions: Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease

Summary: the aim of this study is to assess the effectiveness of a communication intervention about sexuality on quality of life and other outcomes like physical activity, exercise capacity and health status in people with chronic obstructive pulmonary disease (copd).

human sexuality is a universal part of living and associated with quality of life and mental and physical health benefits. improved sexual relationships and sexual activity might also be an intrinsic motivator to stay physically active. however, problems with sexuality and loss of sexual drive are common in older and chronically ill people like persons with chronic obstructive pulmonary disease (copd). in persons with copd sexuality is rarely addressed during medical consultations and the topic is not sufficiently researched despite the fact that a thorough assessment of quality of life is incomplete without considering sexuality. based on this background, the investigators developed an instrument that supports healthcare professionals to start and shape communication about sexuality: cosy. the cosy intervention consists of four tools (communication leaflet for health care professionals, application guidance, pictorial representation of the spectrum of intimacy for health care professionals, patient information booklet) and aims to sensitize persons with copd with the topic sexuality. the aim of this study is to assess the effectiveness of the cosy communication intervention on quality of life and other outcomes like physical activity, exercise capacity and health status in people with copd.

Eligibility criteria:
inclusion criteria: * age ≥60 years * diagnosis of copd, defined as forced expiratory volume in 1s/forced vital capacity (fev1/fvc)\<70% predicted, fev1\<80 % predicted after bronchodilation corresponding to a global initiative on obstructive lung disease (gold) stage ii-iv * knowledge of german language to understand study material and assessments and being able to give informed consent as documented by signature exclusion criteria: * unstable copd at the time of recruitment, unstable cardiovascular comorbidities, severe depression, or predicted life expectancy of less than one year, as judged by the referring clinician or the intervention physician

Keywords: quality of life copd intimacy and sexuality communication intervention physical activity randomized controlled trial
role of cgms usage in predicting risk for hypoglycemia

Conditions: Type 2 Diabetes Mellitus; Hypoglycemia

Summary: this is a clinical study to examine rates hypoglycemia (self-report, ehr review, and review of values from a fda approved continuous glucose monitoring system (cgms)). subjects will wear either blinded or unblinded cgms. this is a 1:1 assignment with one group (50%) wearing 1 unblinded/1 blinded cgms and the other group 50% wearing 2 blinded cgms. the assignment will be computer based in a random fashion. participants will continue with their usual diabetes management and glycemic monitoring profile as per usual. those assigned to an unblinded cgms can use the cgms to manage their glucose levels at their own discretion. individuals recruited will be those type 2 diabetes who are deemed to be at high risk for hypoglycemia or low risk for hypoglycemia from a point score system established in an affiliated study.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 18 years or older exclusion criteria: * type 1 diabetes * current pregnancy or anticipation of pregnancy during study period * at screening visit, hr\> 130 or sbp\>160 or dbp\>100 which remains present on recheck
cognitive training in children with attention deficit/ hyperactivity disorder (adhd)

Conditions: ADHD

Summary: the purpose of this study is to determine the effect of computer program c8 on specific cognitive functions, symptoms and functional outcome compared to treatment as usual in children with adhd. furthermore, if the effect is sustained 12 and 24 weeks after training. in addition, it will be investigated, whether younger children benefit more from training than older children.


Eligibility criteria:
inclusion criteria: 1. adhd- diagnosis 2. age 6-13 years 3. patient has access to computer og internet from home 4. informed consent exclusion criteria: 1. comorbidity: conduct disorder, autism spectrum disorders, depression, or schizophrenia 2. head trauma or neurological disease 3. intelligence quotient (iq) \< 80 4. motoric or perceptual handicap 5. medical disease requiring treatment 6. no informed consent

Keywords: adhd
liver enzymes and metabolic risk factors response to laser acupuncture versus cupping therapy in fatty liver

Conditions: Fatty Liver

Summary: fatty liver disease is characterized by low antioxidants, disturbed lipid metabolism, cardioautonomic functions, and elevated blood measures (glucose, inflammatory markers, liver enzymes)

in fatty liver patients,applied cupping (with scarification) will be compared, regarding its effect on antioxidant, lipid metabolism, cardioautonomic functions, and blood measures (glucose, inflammatory markers, liver enzymes), to application of laser on acupoints

Eligibility criteria:
inclusion criteria: * fatty liver obese patients exclusion criteria: thoracic diseases heart diseases kidney diseases
glivec phase ii pediatric study

Conditions: Cancer

Summary: the purpose of this study is to determine whether glivec is effective, in children, adolescents and young adults, in the treatment of malignant disease in which evidence suggests a potential pathogenic role of one or more of the tyrosine kinases known to be inhibited by glivec.


Eligibility criteria:
inclusion criteria: * patients from 6 months to 21 years of age. * malignant disease documented by conventional criteria to be refractory to standard, approved therapy, or for which no conventional therapies of definitive benefit exist. * immunohistochemistry documentation of positivity of either kit (cd117) or pdgf-r in tumor tissue relevant. each positive tumor will be centrally reviewed before inclusion of the patient in the trial. * measurable or evaluable disease. * who performance status 0,1, or 2 or lansky play scale \>= 50%. * adequate organ function, defined as the following: total bilirubin \ 1x 109/l, platelets \> 75 x 109/l. * female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. * male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug. * life expectancy of more than 6 weeks. * written, voluntary, informed consent, including consent for retrieval and investigational use of tissue samples for evaluation signed by parents or young adult patients. * national and, when needed, local ethical approval. exclusion criteria: * patient with hematological disease positive for the chimeric bcr-abl fusion protein or for c-kit. * patient has received any other investigational agents within 28 days of first day of study drug dosing. * female patients who are pregnant or breast-feeding. * patient has another severe and/or life-threatening medical diseasepatient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis). * patient has a known diagnosis of human immunodeficiency virus (hiv) infection. * patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-c or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by the study coordinator.
the study of p62/sqstm1 as a malignant transformation marker for oral potentially malignant disorders and a prognostic marker for oral squamous cell carcinoma

Conditions: Oral Potentially Malignant Disorder; Oral Cancer; Malignant Disorder; p62/SQSTM1

Summary: the mortality rate of oral cancer in taiwan is still high with no decrease. one of the reasons result in these situations is the patent visits hospital for treatment in late stage of oral cancer. recently, the government makes effort in oral cancer screening to find oral potentially malignant disorders (opmd) early. however, there is no conscience in treatment strategies of opmd up to now. in this study, we will set a opmd data bank, and use the cases to find out the potential biomarker, which is able to predict the oral cancer malignant transformation. sixty opmd with oral cancer transformation will be recruited, and 60 opmd with no oral cancer malignant transformation will also be enrolled as the disease control group. besides, 20 normal cases and 60 oral cancer cases resulting from previous opmd will be collected. all those groups will detect the expression of p62/sqstm1 to investigate the possibility that p62/sqstm1 as a biomarker to predict the malignant transformation of opmm, and a guideline to treat or not to treat opmd.


Eligibility criteria:
inclusion criteria: study group was oral precancerous lesions in patients with malignant transformation; control group was generally no precancerous disease and orthodontic surgery volunteer exclusion criteria: oral mucosa of subjects is too thin
mid-term effect observation of biodegradable conduit small gap tublization repairing peripheral nerve injury

Conditions: Peripheral Nerve Injuries

Summary: to observe the mid-term clinical effect of biodegradable conduit small gap tublization to repair peripheral nerve injury in multi-center．

in the study，150 cases of fresh peripheral nerve injury in the upper extremities are recruited in multi-center． after formally informed and obtaining the consent，the biodegradable conduit small gap tublization are used to repair the nerve．their nerve functional recovery conditions are clinically observed according to the standard score methods provided by shen ning-jiang and british medical research council at 3 years after surgery．the excellent and good rates of the overall nerve functional recovery are calculated．

Eligibility criteria:
inclusion criteria: * fresh peripheral nerve injury in the upper extremities exclusion criteria: * acute myocardial infarction history within 6 months, * old and pathological peripheral nerve injury, * acute and chronic infection, * various consumptive diseases * unable to tolerate surgery

Keywords: peripheral nervous system diseases wounds and injuries nerve regeneration biocompatible materials surgical procedures
a mono-center study in healthy volunteers on the comparative bioavailability of pletal 100 mg tablets and a new pletal 100 mg orodispersible tablet (odt), this latter in fasting conditions with and without water and under fed conditions

Conditions: Intermittent Claudication

Summary: the primary objective of this trial is to test whether pletal odt administered without water can be considered bioequivalent to pletal administered with 200 ml water (both treatments being administered after fasting and at least 30 minutes prior to receiving a light breakfast) based on the standard pharmacokinetic variables. the secondary objective is to assess the effect of water and the effect of food on the administration of pletal odt based on standard pharmacokinetic variables.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects of caucasian race 2. able to read, to write and to fully understand german language 3. having given voluntary written informed consent before first invasive screening examination procedure 4. aged 18 to 45 years, inclusive 5. bmi of 18 - 28 kg/m2 6. good health as determined by medical history, physical examination, vital signs, electrocardiogram (ecg, serum/urine biochemistry and hematology) exclusion criteria: 1. clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) drug hypersensitivity 2. known hypersensitivity to one of the imp substances 3. severe digestive disorder or surgery of the digestive tract (except for appen¬dectomy) 4. clinically relevant renal disorders (albuminuria, chronic infections) 5. clinically relevant hepatic disorders 6. clinically relevant respiratory disorders 7. clinically relevant cardiovascular disorders, especially any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, or a history of additional risk factors for torsades de pointes (tdp) (e.g. heart failure, hypokalemia, congenital long qt-syndrome) 8. diabetes mellitus and thyroid dysfunction or other endocrine disorders 9. malignancy 10. substance abuse or addiction (alcohol, illicit drugs) in the past 3 years 11. neurologic or psychiatric illness 12. known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, surgery within the previous three months, proliferative diabetic retinopathy, poorly controlled hypertension)
efficacy and safety study of ticagrelor

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, group 1:received clopidogrel 75mg qd ;group 2:received clopidogrel 150mg qd ; group 3:received ticagrelor 90mg bid after pci.platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(vasp) analysis before pci,and 3days,7days and 1 month after pci,respectively.the aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

Eligibility criteria:
inclusion criteria: * 1.clinical diagnosis of acs 2.undergoing pci 3.with clopidogrel resistance exclusion criteria: * 1.any contraindication against the use of clopidogrel and ticagrel 2.contradiction to aspirin and contrast medium 3.life expectancy less than 1 year 4.tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome p-450 3a inhibitor or inducer 9.a history of asthma.

Keywords: acs cr pci platelet funtion ticagrelor
influence of lachrymal substitutes on tear film thickness in patients with moderate dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. topically administered lubricants are the basis for treatment of this disease. however, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. recently a new method for assessment of tear film thickness based on optical coherence tomography (oct) has become available. the aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular thealoz duo® eye drops, hyabak® eye drops and hydrabak® eye drops in patients with moderate dry eye disease. in addition, standard tests for dry eye syndrome, such as the ocular surface disease index (osdi©), schirmer i test and determination of tear break up time (but) will be performed..


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * signed and dated written informed consent. * history of dry eye syndrome for at least 3 months * tear break up time (but) ≤ 10 seconds or schirmer i test ≤ 5 mm and ≥ 2mm * osdi (ocular surface disease index) ≤ 32 and ≥ 13 * normal ophthalmic findings except dry eye syndrome, ametropia \< 6 dpt. * no administration of topical lubricants 24 hours before the screening examination exclusion criteria: * participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day * presence or history of a severe medical condition as judged by the clinical investigator * intake of parasympathomimetic or anti-psychotic drugs * wearing of contact lenses * glaucoma * treatment with corticosteroids in the 4 weeks preceding the study * topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study * ocular infection or clinically significant inflammation * ocular surgery in the 3 months preceding the study * sjögren's syndrome * stevens-johnson syndrome * history of allergic conjunctivitis * ametropia \>= 6 dpt * pregnancy, planned pregnancy or lactating * known hypersensitivity to any component of the study medication. * any medical or surgical history, disorder or disease such as acute or chronic severe organic disease * inability to understand the study procedures

Keywords: topical lubricants optical coherence tomography tear break up time schirmer i test
a trial of a home based walking program as an alternate program for non attenders at cardiac rehabilitation

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to investigate if a home-based walking program is an acceptable alternative for those who choose not to attend formal cardiac rehabilitation programs and if such a program has an effect on coronary risk or physical fitness.

coronary heart disease (chd) is the most important cause of life years lost in northern ireland (ni). a recently updated cochrane review (joliffe et al, 2003) confirmed the findings of earlier meta-analyses (o'connor et al, 1989; oldridge et al, 1988) which indicated that participation in cardiac rehabilitation (cr) reduces mortality after mi. the earlier work demonstrated a reduction of 20-25% in all-cause and cardiac mortality. the recent work allowed analysis of an increased number of patients (8440 in 32 trials) and reported a reduction in total cardiac mortality of up to 31%. participation in cr after mi also improves well-being and reduces disability (nhs, 1998). however, informal reports suggest that only approximately 50% of patients actually attend a hospital based program. the hypothesis to be tested is that for those who chose not to attend formal cr, a home-based walking program is an acceptable alternative. this programme of work entails two separate study designs. to evaluate the home-based walking program, we plan a randomised controlled trial (rct). randomisation of subjects to study groups will follow determination of eligibility to participate. participants randomised to the experimental group will be asked to walk for up to 30 minutes, 5-days per week. they will be requested to record aspects of their walking in a diary, including time, intensity and number of steps taken (recorded using a pedometer). qualitative methodology using semi-structured interviews will be used to explore the experiences of those allocated to the intervention group. the attitudes and experiences of other non-attenders of cr who declined to participate in the trial will be explored in focus groups. three focus groups each containing 8 participants are planned. focus group transcripts will be analysed independently by two observers using a computer program (nudist) to identify themes and develop questions for the semi-structured interviews. analysis of the semi-structured interviews will be descriptive, responses being categorised into themes as appropriate. rct results will be analysed by intention to treat.

Eligibility criteria:
inclusion criteria: * justification of diagnosis of myocardial infarction by report of cardiac bio-markers or electrocardiogram changes exclusion criteria - planned for rct - applied to small pilot: * heart failure/ cardiogenic shock * complex ventricular arrhythmias * mental/physical impairment (exclude if housebound/dementia) * valve disorder-severe stenotic or regurgitant lesion * hypertrophic cardiomyopathy * exercise stress test result- exclude if st depression\>=2 mm or angina at \ =1 mm on resting ecg )

Keywords: cardiac rehabilitation walking acute myocardial infarction secondary prevention
safety of lung cryobiopsy in people with cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (tbcb) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; tbfb). the study researchers think that tbcb may provide better biopsy samples to help diagnose lung disease.


Eligibility criteria:
inclusion criteria: * 18 years of age or greater * patients with known or suspected diagnosis of cancer and indeterminant pulmonary nodules or diffuse parenchymal lung disease with non-diagnostic clinical profiles for whom a lung biopsy is deemed useful for diagnosis. exclusion criteria: * patients with pulse oximetry less than 92% on oxygen delivery up to 2 l nasal cannula. * uncorrectable coagulopathy defined as: * platelet count \<50,000 x 10\^9/l or * prothrombin time international normalized ratio \>1.5 * known pulmonary hypertension or echocardiographic pulmonary artery systolic pressure \>50mmhg * a secure diagnosis based on clinical and high-resolution ct scan data. * antiplatelet therapy that cannot be held for more than 5 days. * any patient deemed unfit to undergo bronchoscopy by the proceduralist * female patients with a positive pregnancy test within 30 days of the planned study procedure

Keywords: cryobiopsy 20-374
a clinical study of b007 in the treatment of pemphigus.

Conditions: Pemphigus

Summary: the purpose of this study is to evaluate the efficacy and safety of b007 in subjects with pemphigus.


Eligibility criteria:
inclusion criteria: 1. subjects who voluntarily participate in this study and sign informed consent form; 2. subjects who meet the clinical manifestations of pemphigus and are clinically diagnosed as prescribed diseases; 3. subjects with first diagnosis or relapse; 4. subjects who have the ability to follow the study protocol as determined by the investigator. exclusion criteria: 1. subjects diagnosed with prescribed diseases; 2. since the diagnosis of pemphigus, disease duration\>4 years; 3. subjects using prescribed drugs; 4. presence of a specified disease or history of disease; 5. the subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator; 6. a history of severe allergy or allergic reaction to human or mouse monoclonal antibodies; known contraindications to orally prescribed drugs; 7. subjects who participate in another interventional clinical trial at a specified time before randomization; 8. subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose; 9. pregnant and lactating women; 10. fertile female subjects do not agree to use effective contraception from signing the informed consent form to the prescribed time after the last dose. women who are considered fertile by the investigator must have negative serum pregnancy tests before starting the drug; 11. sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within specified time after the last dose, or male subjects who plan to donate sperm at a specified time during the trial or after the last dose. 12. other conditions deemed unsuitable for participation in this study by the researchers.