Kornimate/medical-research-clean huggingface dataset:
a randomized, double-blind, 4-way crossover study to evaluate the efficacy of of 24 hour spirometry profiles of inhaled bi 1744 cl and inhaled tiotropium bromide in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the study is intended to characterize the lung function profile of bi1744 in chronic obstructive pulmonary disease (copd) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. each patient will receive all four treatments.


Eligibility criteria:
inclusion criteria: * patients willing to participate with confirmed diagnosis of copd * 40 years of age or older * having a 10 pack year smoking history * able to perform serial pulmonary function tests * able to use both a dry powder inhaler (dpi) and respimat device exclusion criteria: * significant other disease * clinically relevant abnormal hematology, chemistry, or urinalysis * history of asthma * diagnosis of thyrotoxicosis * paroxysmal tachycardia related to beta agonists * history of mi within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year * active tuberculosis, cystic fibrosis, clinically evident bronchiectasis * significant alcohol or drug abuse * pulmonary resection * taking oral beta adrenergics * taking unstable oral steroids * daytime oxygen * enrolled in rehabilitation program * enrolled in another study or taking investigational products * pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control * those who are not willing to comply with pulmonary medication washouts
efficacy and safety of dkf-ma102 in patients with prostate cancer

Conditions: Advanced Prostate Cancer

Summary: a phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of dkf-ma102 in patients with prostate cancer.

this study is conducted to confirm the pharmacodynamic effects, efficacy, and safety of dkf-ma102 in prostate cancer patients by measuring the changes in serum testosterone levels.

Eligibility criteria:
inclusion criteria: 1. adult male aged 19 or older 2. histologically or cytologically-confirmed prostate cancer 3. serum testosterone level \>150 ng/dl 4. ecog ps grade ≤ 2 5. life expectancy of at least 1 year exclusion criteria: 1. history of surgical procedures such as testicular resection, adrenal resection, and pituitary resection 2. history of hormone therapy 3. history of 5α-reductase inhibitor 4. history of radical radiation therapy 5. history of adjuvant male hormone block therapy 6. severe liver failure 7. serum creatinine ≥1.5 times the uln 8. hormone-independent prostate cancer 9. diagnosed pituitary adenoma 10. brain metastasis or spinal cord compression 11. requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period 12. urinary tract obstruction 13. cardiovascular disease 14. significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system 15. uncontrolled diabetes 16. allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic gnrh or gnrh analogs 17. severe asthma, severe vascular edema, and severe hives 18. significant infection 19. lack of self-determination due to psychiatric illness 20. participating in another interventional clinical trial 21. pregnant or unwilling to use medically approved contraception 22. deemed inappropriate to participate in this clinical trial by the investigator
clinical study to evaluate the effects of two novel hydration beverage formulas on rehydration in healthy adults

Conditions: Dehydration; Rehydration; Exercise Performance; Exercise Recovery; Cognitive Performance

Summary: the aim of the clinical trial is to evaluate the efficacy of two novel hydration products on rehydration following exercise.


Eligibility criteria:
inclusion criteria: * healthy adult male and female participants who are between 18 and 49 years of age (inclusive). are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit. have a body mass index (bmi) between 17.0 and 29.9 kg/m2 (inclusive). exercise regularly as per physical activity guidelines for americans \[structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)\] and willing to maintain the same level of physical activity throughout the study period. can maintain their exercise status at the beginning of the study throughout the study period. can achieve a peak vo2 at screening that is at least 60% of their age and gender matched normative value per american college of sports medicine recommendations. have normal or acceptable to the investigator vital signs (bp and hr) at screening. individuals with childbearing potential: agree to have urine pregnancy test performed on each trial day. able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures. exclusion criteria: * female participants who are lactating, pregnant or planning to become pregnant during the study. carry a diagnosis of diabetes. weigh less than or equal to 80 pounds at any visits. answer "yes" to any of the questions asked on the screening questionnaire (appendix 10.2.1). have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., hiv/aids), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit). use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (familiarization trial/visit 2). participants must observe a 30-day washout period of no supplementation to be eligible. consume more than two standard alcoholic drinks per day. use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study. have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume. smoking tobacco products.
iowa fluoride study/iowa bone development study

Conditions: Dental Caries; Dental Fluoroses; Bone Density

Summary: a cohort of newborns was recruited for the iowa fluoride study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. standardized dental exams were conducted at \~ages 5, 9, 13, 17, and 23. at about age 5, participants were invited to join the offshoot iowa bone development study. bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. these included dual-energy x-ray absorptiometry (dxa) of hip, lumbar spine, and whole body from age 5; peripheral quantitative computed tomography (pqct) of the radius and tibia from age 11; and multi-detector computed tomography (mdct) of the tibia from age 19. physical activity and other factors also were assessed longitudinally.

a cohort of newborns was recruited for the iowa fluoride study from 1992-95 to assess the complex relationships among fluoride intakes, fluoride exposures, dental fluorosis, and dental caries. detailed questionnaires were sent every 1.5-6 months concerning water sources, fluoride exposures, dietary intakes, etc. standardized dental exams were conducted at \~ages 5, 9, 13, 17, and 23. at about age 5, participants were invited to join the offshoot iowa bone development study. bone densitometry assessments were conducted at ages 5, 8, 11, 13, 15, 17, 19, and 23. these included dual-energy x-ray absorptiometry (dxa) of hip, lumbar spine, and whole body from age 5; peripheral quantitative computed tomography (pqct) of the radius and tibia from age 11; and multi-detector computed tomography (mdct) of the tibia from age 19. physical activity and other factors also were assessed longitudinally.

Eligibility criteria:
inclusion criteria: * healthy newborn exclusion criteria: * not health newborn

Keywords: fluoride genetics physical activity diet
a phase 1 study to assess the effects in the body of a single dose of trientine dihydrochloride in wilson's disease patients

Conditions: Wilson's Disease

Summary: to evaluate the effects of a single dose of trientine in children ≥6 years and adult patients with wilson's disease.

an open, single-dose study to determine the pharmacokinetics, and safety of oral administration of trientine dihydrochloride in both children and adult patients with wilson's disease. blood samples will be taken pre-dose and at 10 time-points post-dose to investigate the pharmacokinetic profile of trientine dihydrochloride up to 12 hours after intake of study medication in 20 patients.

Eligibility criteria:
inclusion criteria: 1. children ≥ 6 years and adult patients 2. confirmed diagnosis of wilson's disease by leipzig-score \>3 (ferenci et al 2003) 3. current treatment with trientine dihydrochloride 4. signed informed consent including parental consent in patients ≤ 18 years 5. agree to remain in the study site1 for the pk measurements period. exclusion criteria: 1. known clinically significant allergy or hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient's safety 2. have any clinically significant conditions that would interfere with the collection or interpretation of the study results or would compromise the patient's health 3. women of child bearing potential who do not use contraceptives, breastfeeding, or pregnant women 4. severe anaemia (haemoglobin \<9 mg/dl) 5. in the judgment of the investigator, is likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development 6. participation in any interventional clinical study at the same time or within the 4 weeks prior his study.

Keywords: trientine pharmacokinetics
evaluation of pro-inflammatory leukocyte activity in patients undergoing cardiac surgery

Conditions: Congenital Heart Disease; Coagulation

Summary: the goal of this proposal is to prospectively collect data from a series of 100 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (cpb) to: 1. measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum gaba and pro-inflammatory cytokine levels 2. understand the correlation between gaba and inflammatory cytokines (and/or activated monocytes) and 3. assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under cpb and at risk of thrombosis.

often when people undergo heart surgery, they are placed on cardiopulmonary bypass (cpb). sometimes clotting of the blood occurs during and after heart surgery with cpb, which can lead to multiple complications. in order to try to avoid abnormal/excessive clotting that may lead to complications, it is important to understand the specific causes of why the blood sometimes clots abnormally during and after heart surgery. currently, tests looking at how the blood clots (coagulation assessment) are usually performed as standard laboratory testing during and after surgery. however, these tests are not able to predict the future development of abnormal clots. this study will be looking at the role that immune cells (monocytes) have in the formation of abnormal clots after heart surgery. it is possible that these immune cells produce signals that can contribute to the formation of clots. using experimental tests (monocyte analysis and mediator analysis), the hope is to understand if these cells participate in forming abnormal clots in any meaningful way. although these tests are not yet approved for use in children, this study plans to use these new methods to understand this phenomenon by analyzing the blood at different times during the surgery and recovery period. overall, the purpose of this study is to look at these tests in people undergoing heart surgery to help the investigators understand why the blood sometimes forms clots abnormally. results from this study may help treat future patients who experience abnormal clotting during and after surgery.

Eligibility criteria:
inclusion criteria: * patients (all ages) undergoing complex cardiac surgical procedures with cpb. exclusion criteria: * undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent * patient in a moribund condition american society of anesthesiology (asa 5) -patient with a hematological and/or oncological disease * jehovah witnesses.
functional outcomes after radial head fractures treated non-operatively

Conditions: Radial Head Fracture

Summary: the purpose of this study is to investigate the effects of physical therapy as part of the non-operative treatment of radial head fractures.there is currently no data to support the use of physical therapy in the non-operative treatment of radial head fractures. likewise, there is no data that shows that physical therapy is harmful to patients being treated non-operatively for radial head fractures. investigators believe that prescribing physical therapy for patients with non-displaced radial head fractures treated non-operatively is unnecessary, and that that it would be equally efficacious to teach patients simple stretching exercises that they could perform by themselves. subjects will be randomized into 2 groups: group 1 - patients will be prescribed physical therapy within the first month following fracture; group 2 - patients will be given simple stretching exercises to perform at home and will not be given a prescription for physical therapy. patients who agree to participate in this study and sign the informed consent will be randomly assigned to one of the two groups.


Eligibility criteria:
inclusion criteria: * individuals to be approached for participation in this study will include all adult (age \> 18 years old) patients who are receiving or seeking medical care in the outpatient setting. exclusion criteria: * patients who are initially determined to need surgical fixation of a radial head fracture will not be included in this study. there are no additional exclusion criteria.
effectiveness of mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain

Conditions: Chronic Neck Pain

Summary: the aim of our study is to compare the efficiency of mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. the results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.

the aim of our study is to compare the efficiency of mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. the results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively. the hypotheses we will test for this purpose; h1. home exercise program will improve positively after treatment in patients with chronic neck pain compared to before treatment. h2. mulligan mobilization will improve positively after treatment in patients with chronic neck pain compared to before treatment. h3. cervical stabilization training will improve positively after treatment in patients with chronic neck pain compared to before treatment. h4. mulligan mobilization will provide more effective results in patients with chronic neck pain compared to other applications.

Eligibility criteria:
inclusion criteria: * having neck pain lasting more than 3 months * expressing neck pain at least 3,5/10 points and above on a visual analog scale * being 18-65 years old * agree to participate in the study * having obtained 5/50 points and above in neck disability index exclusion criteria: * having had spinal surgery * other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis. * having a diagnosed psychiatric illness * having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year. * the presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease. * any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above. * difficulty in communication at a level that prevents the application of evaluations and / or treatment.
severe soft tissue infections: perspectives of patients and significant others

Conditions: Necrotizing Fasciitis

Summary: severe necrotizing soft tissue infection (nsti), including necrotizing fasciitis, is a life threatening infection that spreads quickly to cutis, sub-cutis, fasciae and muscles. approximately 40% of all patients with infections caused by s. pyogenes develop a streptococcal toxic-shock syndrome. in these cases the mortality rates exceed 40% in spite of adequate treatment with antimicrobials. due to the rapid progress, the extensive damage on soft tissues and high risk of death, the microbes are called "flesh-eating bacteria". the present study is a spin-off of the larger eu funded infect study, looking at the experiences of patient and family to understand the impact on every day life. the present prospective mixed methods study has the potential to provide important knowledge regarding the occurrence of early signs and symptoms of nsti, quality of life 6 and 24 months after diagnosis, and how the care and treatment can be optimized and organized in a person/patient and family centered way. the study also aims at validate the sf 36 questionnaire for this group of patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with necrotizing fasciitis and their significant others * age above 18 yrs exclusion criteria: * persons with dementia or severe psychiatric illness * persons that do not master the scandinavian language
monocular-camera-based mobile exergame for type 2 diabetes prevention

Conditions: Behavior Change Interventions

Summary: exergames have demonstrated potential as effective interventions for promoting physical activity and preventing type 2 diabetes (t2d), particularly among older adults. kinect-based exergames, in particular, have been associated with improved adherence to exercise regimens and positive health outcomes. however, widespread implementation is limited by the high cost and reduced accessibility of the required hardware, restricting their use in home-based settings. recent advances in computer vision have enabled the development of exergames using monocular camera systems, which may represent a cost-effective and scalable alternative. this study investigates the feasibility of monocular-camera-based exergames as a cost-effective and convenient alternative for home-dwelling individuals. a total of 45 community-dwelling older adults aged 60-74 years, identified as high risk for t2d were recruited through local community health centers. participants were randomly assigned to one of three groups (n = 15 per group): (1) control group (traditional offline exercise with printed instructions), (2) kinect group (kinect-based exergames targeting aerobic capacity, balance, and strength), and (3) monocular group (monocular-camera-based exergames using real-time 2d pose estimation). the intervention lasted six weeks, with participants completing three 30-minute sessions per week at home. primary outcomes included exercise performance (completion rate and movement accuracy) and intrinsic motivation. secondary outcomes included perceived enjoyment, challenge, and usability. data were analyzed using one-way anova.


Eligibility criteria:
inclusion criteria: 1. age between 60-74; 2. a score of 25 or higher on the chinese diabetes risk score; 3. community-dwelling individuals, not reside in assisted living or long-term care facilities; 4. physically capable of engaging in light to moderate exercise, as determined by self-report and/or physician clearance; 5. normal cognitive function that enable the participant to complete the experiment independently or with minimal assistance; 6. written informed consent provided by participants or their families. exclusion criteria: 1. diagnosis of type 1 or type 2 diabetes; 2. current participation in another exercise intervention study; 3. severe cognitive impairment with mmse \< 24; 4. major mobility limitations such as severe osteoarthritis and recent orthopedic surgery.

Keywords: exergame individuals at high risk of type 2 diabetes
digital diabetes self management education and support for patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to test the effect of using a digital diabetes self management education and support system compared with standard care for patients with type 2 diabetes in primary health care.

after being informed verbally and in text participants will sign a consent to participate. the participant will then be randomized to either use a digital diabetes self management education and support system for 10 weeks together with a diabetes nurse, or to continue with the regular care. the effects will be evaluated after 6, 12 and 36 months from randomization with emphasis on cardiovascular risk factors, life-style, diabetes knowledge and health economics.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed according to who criteria \< 5 years from randomization: * fasting plasma glucose \> 7 mmol/l at two timepoints. or * hba1c ≥ 48 mmol/mol twice or in combination with fasting plasma glucose \> 7 mmo/l once. or * non-fasting plasma glucose ≥ 11.1 mmol/l at one timepoint in combination with symptoms of hyperglycemia. * access to a digital id-card to access the digital system * access to a computer, tablet or smart phone * sufficient knowledge of written and spoken swedish to understand the information given in the digital system. exclusion criteria: * treatment with insulin * other co-morbidities limiting the use of the digital system according to the diabetes nurse judgement. e.g. dementia or severe psychiatric disease. * other forms of diabetes mellitus than type 2 diabetes.

Keywords: mhealth primary health care type 2 diabetes