Kornimate/medical-research-clean huggingface dataset:
open-label study assessing the safety, immunogenicity and dose response of ic47

Conditions: Pneumococcal Infections

Summary: the main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of ic47 up to 6 months after the first vaccination. a total of 32 healthy subjects (male or female) will participate in this clinical study. the subjects will be divided into 4 groups of 8 subjects each. thirty (30) μg or 150 μg of ic47 will be administered three times in intervals of 42 days each.

this phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. the following table shows the design of the different study groups. the amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.

Eligibility criteria:
inclusion criteria: * written informed consent * healthy adults ≥ 18 to \</= 65 * female subjects: post-menopausal or practicing reliable methods of contraception during the study exclusion criteria: * history of autoimmune diseases and malignancies. * history of severe hypersensitivity reactions and anaphylaxis. * immunodeficiency due to immunosuppressive therapy. * infection with hiv, hepatitis b or hepatitis c. * pregnancy, lactation * vulnerable subjects

Keywords: prevention of pneumococcal infections
the effect of telephone-assisted smoking cessation program in patients diagnosed with non-muscle invasive bladder cancer

Conditions: Non-Muscle Invasive Bladder Cancer; Self Efficacy; Smoking Behaviors; Tumor Recurrence; Progression, Disease

Summary: this study will be carried out to examine the effect of telephone-assisted smoking cessation program on self-efficacy, smoking behavior, tumor recurrence and progression in patients with non-muscle invasive bladder cancer.

this study will be conducted to examine the effect of a telephone-assisted smoking cessation program (3 months) on self-efficacy, smoking behavior, tumor recurrence and progression for chronic disease management in patients diagnosed with non-muscle invasive bladder cancer. after 3 months of motivational interviewing was applied to the experimental group, the scales will be applied in the 3rd, 6th and 12th months. the cystoscopy will be performed at 3 and 12 months for tumor recurrence and progression

Eligibility criteria:
inclusion criteria: * being 21 years or older * first-time diagnosis of non-muscle invasive bladder cancer (patients with pta urothelial cancer) * chronic smoking for at least 1 year * at least primary school graduate and can speak turkish * having a smartphone and internet access * no communication barrier (speech, vision or hearing problem) * individuals who agree to participate in the research. exclusion criteria: * patients with positive cis (carcinoma in situ) * patients with minimal invasion of the lamina propria and above * patients with extravesical extension * patients with synchronous and metachronous tumors * communication disability (speech, vision or hearing problem)
rehabilitation in lumbar disc herniation

Conditions: Symptomatic Lumbar Disc Herniation

Summary: the aim of this study is to compare the effects of written and video based home exercise program in patients with symptomatic lumbar disc herniation on pain level, function and quality of life.

45 symptomatic lumbar disc herniation patients, who are in chronic period and aged between 18-65 years, will be included. the participants will be randomised into three groups. 15 patients will be included in the written home exercise group,15 patients will be in video based home exercise group and 15 patients in the control group. in the written exercise group and video based exercise group, exercise programs will be 8 weeks. in the control group, the exercise protocol will not be performed during 8 weeks. the outcomes will include the quality of life, pain level, functional capacity, kinesiophobia. in the exercise groups, the evaluations will be made in the first interview (before exercise program), at the end of 8 weeks of exercise (when the exercise program is completed) and in 12th weeks (4 weeks after the exercise program completion). evaluations in the control group will be carried out at the first interview, at the 8th week, 12th weeks.

Eligibility criteria:
inclusion criteria: * aged between of 18-65 years * having been diagnosed with a lumbar disc herniation * no need for surgery due to lumbar disc herniation * having pain in the lower back or leg for at least 12 weeks * not using corticosteroids * to be oriented and cooperative * to be volunteer to participate in the study exclusion criteria: * having undergone lumbar spine surgery * having undergone lower extremity, upper extremity, spine surgery in the last 1 year * presence of lumbar stenosis * analgesic addiction, or any addiction * presence of tumor * presence of metastases * presence of rheumatological diseases * the presence of scoliosis, congenital deformity * presence of leg length discrepancy * being pregnant * to have uncontrolled hypertension * to have exercise-dependent angina
dose escalation of bivatuzumab mertansine in female patients with cd44v6 positive recurrent or metastatic breast cancer

Conditions: Breast Neoplasms

Summary: maximum tolerated dose (mtd), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility criteria:
inclusion criteria: 1. female patients aged 18 years or older 2. patients with breast cancer positive for cd44v6 in at least 50 % of the tumour cells 3. patients with local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments 4. measurable tumour deposits by one or more radiological techniques (mri, ct) 5. life expectancy of at least 6 months 6. eastern cooperative oncology group (ecog) performance score ≤ 2 7. patients must have given written informed consent (which must be consistent with international conference of harmonisation-good clinical practice (ich-gcp) and local legislation) exclusion criteria: 1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs 2. known secondary malignancy requiring therapy 3. active infectious disease 4. brain metastases requiring therapy 5. neuropathy grade 2 or above 6. absolute neutrophil count less than 1,500/mm3 7. platelet count less than 100,000/mm3 8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/l, système internationale (si) unit equivalent) 9. aspartate amino transferase (ast) and/or alanine amino transferase (alt) greater than 3 times the upper limit of normal 10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/l, si unit equivalent) 11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug 12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug) 13. radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial 14. women who are sexually active and unwilling to use a medically acceptable method of contraception 15. pregnancy or lactation 16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) 17. patients unable to comply with the protocol
intervention to reduce misused inhaler and insufficient peak inspiratory flow in hospitalized copd patients

Conditions: COPD

Summary: the drug treatment of chronic obstructive pulmonary disease (copd) is mainly based on inhaled therapy. this route of administration is limited by inhaler handling errors, insufficient inspiratory flow or inappropriate inhalers. according to the scientific literature, these limitations are extremely common in both outpatients and inpatients. our hypothesis is that the implementation of a standardised and systematic assessment of inhalers combined with a prescribing guide to help select a suitable inhaler will decrease the proportion of suboptimally used inhalers at discharge in patients hospitalised with a diagnosis of copd. to assess the effectiveness of our intervention, the investigators will compare the proportion of inhalers used suboptimally at hospital discharge between a control cohort before the implementation of our intervention and a cohort after the implementation of our intervention. secondary outcomes include reasons for sub-optimal use of inhalers, i.e. inhaler handling errors, insufficient peak inspiratory flow or inappropriate inhaler. secondary outcomes will also include length of hospital stay and 30-day readmission rate.


Eligibility criteria:
inclusion criteria: 1. admission to the hfr fribourg internal medicine department 2. age greater than or equal to 18 years 3. diagnosis of copd 4. use of an inhaler device for the treatment of copd before admission exclusion criteria: 1. inability to complete initial assessment due to language problems 2. inability to complete initial assessment due to physical or mental conditions 3. patient who has already received the intervention during a previous hospitalization. 4. length of hospitalization of less than 72 hours 5. patient already included in the control period

Keywords: inhaler critical error inspiratory peak flow hospital
vitamin d supplementation on outcome and disease activity.

Conditions: Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Summary: to study efficacy of vitamin d on outcome and disease activity ; das28-esr in rheumatoid arthritis patients at rajavithi hospital .


Eligibility criteria:
inclusion criteria: * age \> 18 yrs old * ra diagnosed by acr/eular 2010 * low to moderate disease activity * on stable nsaids and dmards for at least 1 month * received prednisolone less than or equal to 7.5 mg/day * serum calcium, phosphorus and alp are within normal limit. exclusion criteria: * chronic kidney disease stage 3 or higher * history of tb * history of chronic liver disease * pregnancy or breast-feeding * adjustment of immuno-suppressive drugs, steroid * other connective tissue disease * vitamin d allergy * received other drugs which have vitamin d component * serum vitamin d less than 10 ng/ml
expanded population health model evaluation

Conditions: Chronic Disease; Quality of Life

Summary: this study will evaluate the impact of a comprehensive wellness and social determinants of health intervention on cardiovascular health in a community setting of the bonton neighborhood. participants will not be assigned to intervention activities, but health and wellbeing indicators will be collected in relation to how they choose to participate in activities over the year.

the specific aims of this study are to 1) evaluate whether a population health model integrated into a community setting improves cardiometabolic health and quality of life in adults 18 years or older and 2) evaluate which programs and services provide the most impact for specific sub-groups of individuals, e.g., elderly, individuals with diabetes, etc. participants will receive programs from the existing population health model from baylor scott \& white health and wellness center with additional programs from a local community organization. individuals will complete study measures at baseline, 6 months, and 12 months.

Eligibility criteria:
inclusion criteria: * age 18 years or older * ability to alter diet and/or physical activity * willing to participate in a 12-month study * willing and able to participate in programs at bonton farms * cannot have participated in an intensive lifestyle change program (group lifestyle balance, health eating and lifestyle program, or first cohort of apprenticeship) in the last 6 months or have attended more than two weeks of an intensive lifestyle change program * cannot be diagnosed with a terminal illness * cannot be pregnant or planning to get pregnant in the next 12 months exclusion criteria: * below the age of 18 years * unable to alter diet and physical activity due to medical condition * not willing to participate in a 12-month study * not willing and unable to participate in programs at bonton farms * participated in an intensive lifestyle change program (group lifestyle balance, health eating and lifestyle program, or first cohort of bonton farms' apprenticeship) or has attended more than two weeks of an intensive lifestyle change * be diagnosed with a terminal illness * currently pregnant or planning to get pregnant in the next 12 months

Keywords: life essential 8 cardiovascular disease
ocular and cardiac effects of battle ground

Conditions: COVID-19; Accommodation Spasm; Tachycardia; Stress Reaction; Cardiac Arrhythmia

Summary: mobile battle ground games are widely used in various age groups, there are ocular and cardiac affection that may affect users of this type of action games.

the aim of this study is to assess the possible ocular and cardiac changes that may affect users of this type of mobile games in real life among various age groups and especially in adults with history of recent corona virus (covid-19) disease. there is no medical recommendations about the time and the hazards of using this games for longer periods in real practice.

Eligibility criteria:
inclusion criteria: * normal subjects that are playing or not playing action mobile battle ground games will be included. * post covid-19 subjects with average 6 months of infection and are playing mobile battle. ground games will be included. exclusion criteria: * subjects that refuse to enter the study. * users of mobile battle ground games with other diseases that may affect ocular and cardiac assessment as diabetic eye disease, cardiac congenital anomalies or recent cardiac or ocular surgery.

Keywords: battle ground games accommodation spasm eye strain pulse disorder tachycardia
an evaluation of web based pulmonary rehabilitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by copd.

chronic obstructive pulmonary disease (copd) is a term used to describe a number of lung conditions characterised by irreversible damage to the airways causing airflow obstruction. pulmonary rehabilitation (pr) is a broad programme that helps improve the health and well-being of people with breathing difficulties, most commonly copd. participation in pr leads to improvements in exercise tolerance and functional ability, as well as a reducing breathlessness in everyday activities. it is traditionally an outpatient programme based in a hospital or community setting run by a multidisciplinary team, and usually lead by physiotherapy and nursing staff. typically it includes a physical exercise programme, and advice and education on managing a chronic lung condition. the purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by copd.

Eligibility criteria:
inclusion criteria: * a diagnosis of copd * suitable for participation in the nhs lanarkshire pr programme * independently mobile * access to the internet in their own home exclusion criteria: * unstable cardiac or other health problems which may prevent participation in study * under the age of 18 * pregnant * unable to read/understand english * unwilling to be randomised into pr delivered via the hospital or internet

Keywords: physiotherapy pulmonary rehabilitation exercise telerehab
early abduction splintage on stable hips in infants with developmental dysplasia of the hip

Conditions: Congenital Hip Dysplasia

Summary: the aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).


Eligibility criteria:
inclusion criteria: * term infants * infants between 1 and 2 months of age at inclusion * clinically stable hip * pathological ultrasonography : pubo-femoral distance \>6mm and bony rim percentage \<50% * non objection of the family exclusion criteria: * clinically unstable hip * normal ultrasonography * neuro-orthopedic disease * postural deformity of the pelvis * participation refusal

Keywords: abduction splint pubo-femoral distance
sleep, exercise, nutrition and survivorship in prostate cancer

Conditions: Prostate Cancer

Summary: the primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.

the primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle.

Eligibility criteria:
inclusion criteria: 1. adult u.s. male age \>18 with prostate cancer or 2. adult u.s. male or female \>18 who is a family member/partner/caregiver of a prostate cancer patient and 3. telephone and internet access and 4. able to read, comprehend, and sign informed consent in english and 5. perceived deficits in sleep, nutrition, and/or physical activity exclusion criteria: 1. age \<18 years 2. not english proficient 3. no or irregular access to the same telephone number and/or mailing address 4. no or less than weekly access to the internet 5. patients who do not have a diagnosis of prostate cancer 6. caregivers/family members for a condition other than prostate cancer 7. mental or cognitive impairment that interferes with ability to provide informed consent 8. surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate) 9. other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)
the effects of sex and age differences on gastric cancer : a retrospective study

Conditions: Sex; Age; Gastric Cancer

Summary: gastric cancer (gc) is more prevalent in males than in females. one of these differences could be the effect of sex hormones such as estrogens. however, few reports have been reported regarding sex and age differences of incidence and survival of gc. the aim of this study was to evaluate the effect of sex and age on the incidence and survival of gc. and we would like to further analyze single gc and synchronous multiple gc, ebv, etc.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gastric cancer exclusion criteria: * gastric maltoma * gastric lymphoma * gastrointestinal stromal tumors (gists)
trials of intelligent nighttime brace with smart padding to treat of adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: adolescent idiopathic scoliosis (ais) is a three-dimensional spinal deformity usually associated with intervertebral rotation that takes place during adolescence. generally, bracing treatment is a common option for scoliosis patients. non-surgical treatment for scoliosis patients is to offer a conservative solution to treat their condition and encourage a higher degree of compliance by avoiding interference with their daily life activities. therefore, intelligent nighttime braces have been developed to solve this issue, which are intended to be worn for inhibiting the advancement of spinal deformity during sleeping hours. however, its efficacy is still controversial. intelligent nighttime brace with a specialized design for teenagers with scoliosis is limited and most part of them are lack of mobility and lack of control over corrective forces on particular regions of the vertebra. a scientific approach should be used to design and develop intelligent nighttime brace as a treatment option for adolescents with early scoliosis.

the design of intelligent nighttime brace with smart padding for adolescent idiopathic scoliosis will incorporate different mechanisms, such as 1. compression and pulling forces through a customizable rigid brace 2. lumbar flexion by using a supporting air-belt. 3. three-point pressure system is used to exert corrective forces by the intelligent paddings in the transverse direction 4. adjust the pressure of the brace padding through a pressure monitoring system in accordance with the sleeping posture of the users

Eligibility criteria:
inclusion criteria: 1. between the ages of 10-13, 2. scoliosis with a cobb angle larger between 10 -25 degrees; 3. no prior treatment 4. pre-menarche or post- menarche by no more than 1 year 5. ability to read and understand english or chinese 6. physical and mental ability to adhere to intelligent nighttime braces protocol exclusion criteria: 1. history of previous surgical or orthotic treatment for ais 2. diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature 3. contraindications for pulmonary and/ or exercise tests 4. psychiatric disorders 5. recent trauma

Keywords: scoliosis, bracing treatment
mitral valve in hypertrophic cardiomyopathy

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: the purpose of the study is to assess the role of mitral valve apparatus in the development of outflow tract obstruction in patients with hypertrophic cardiomyopathy and to identify the best surgical treatment modality to relieve outflow tract obstruction in such patients

it is well-known that mitral valve plays an important role in the development of left ventricular outflow tract obstruction in patients with hypertrophic cardiomyopathy. in order to further investigate this phenomenon, the following study aims to compare mitral valve geometry indices, as assessed by transthoracic echocardiography, two- and three-dimentional transesophageal echocardiography and mitral valve quantification analysis, and papillary musles' function, as assessed by 2d speckle tracking imaging, in patients with hypertrophic obstructive cardiomyopathy, patients with arterial hypertension and left ventricular hypertrophy and people without structural heart disease. this will provide information on the geometric characteristics of mitral valve that predispose to the development of obstruction. futhermore, patients with hypertrophic obstructive cardiomyopathy that are eligible for the surgical relief of obstruction will be randomised into four groups according to the modality of intervention. these groups are as follows: 1) isolated extended septal myectomy; 2) extended septal myectomy + edge to edge mitral valve repair; 3) extended septal myectomy + posterior lealfet sliding plasty; 4) extended septal myectomy + secondary chordae transection. after surgery, said indices will be reassessed and the degree of outflow tract obstruction relief noted, in order to elicit which geometrical changes are produced by each type of intervention. patients will be followed long-term, up to 5 years, in order to define whether the addition of the intervention on mitral valve helps abolish the residual gradient more effectively, and whether it translates into any survival benefit.

Eligibility criteria:
inclusion criteria: * age \>18 years * signed informed consent to participate in the study * for patients with hypertrophic cardiomyopathy only: resting or latent peak left ventricular outflow tract gradient \>50 mmhg, nyha class iii-iv * for patients with arterial hypertension only: hystory of arterial pressure increase \>140/90 mmhg, increased left vantricular wall thickness (\>10 mm) and myocardial mass indexed to bsa (\>95 g/m2 for women and \>115 g/m2 for men), as assessed by 2d transthoracic echocardiography exclusion criteria: * age \< 18 years * persistent form of atrial fibrillation * intrinsic mitral or aortic valve disease * coronary artery disease * reduced left ventricular ejection fraction * for control group only: presence of any structural heart disease

Keywords: hypertrophic cardiomyopathy, mitral valve, echocardiography