Kornimate/medical-research-clean huggingface dataset:
an investigational drug study in patients with copd (chronic obstructive pulmonary disease) (mk-0873-005)

Conditions: Lung Diseases; Pulmonary Disease, Chronic Obstructive

Summary: this is a study to evaluate the effectiveness and tolerability of a once-daily oral medication (mk-0873) for the treatment of copd (chronic obstructive pulmonary disease) to determine whether the study drug leads to an improvement in pulmonary (lung) function, as well as symptoms, and quality of life.

following a three-week run-in period (period i) during which participants received placebo, participants entered into a 12-week double-blind treatment period (period ii) during which they received daily doses of either one of three doses of mk-0873 or placebo. period i and period ii made up the base study. following the 12-week treatment period in the base study, participants were invited to continue in an optional 12-week double-blind extension study (period iii, ext1). participants who received any dose of mk-0873 in the base study continued on mk-0873 2.5 mg daily in period iii while participants in the placebo arm of the base study continued on placebo daily. following ext1, participants were invited to continue in an optional open-label second extension study (ext2) which was to last 80 weeks (period iv: 28 weeks, period v: 52 weeks). in ext2, participants who had been taking mk-0873 2.5 mg in the base study were allocated to mk-0873 2.5 mg plus usual care, while participants who had been taking the other two doses of mk-0873 or placebo in the base study were allocated to either mk-0873 2.5 mg plus usual care or to usual care alone.

Eligibility criteria:
inclusion criteria: * males and females, 40 to 75 years old, with a history consistent with copd (chronic obstructive pulmonary disease) * lung function tests that meet the requirements of the study exclusion criteria: * severe and unstable medical conditions other than copd (chronic obstructive pulmonary disease) * use of continuous oxygen therapy * cardiac (heart) arrhythmias * other lung disease * history of colitis (inflammation of the colon)
does the order in which vaccines are administered affect pain response?

Conditions: Pain

Summary: the objective of this study is to determine whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine being given first.

childhood vaccination is one of the most effective public health measures worldwide, with few serious adverse effects reported. however, pain on vaccination continues to be a frequent occurrence and is the most common cause of childhood iatrogenic pain. in a recent study of paediatricians in the usa, more than ninety percent reported at least one parental vaccine refusal in the past year. the most common concerns cited by parents were short-term reactions and pain from multiple injections. one of the factors responsible for vaccination pain is the vaccine material itself. even the same vaccine, when made by different pharmaceutical companies may produce different pain responses. anecdotal reports from doctors and nurses indicate that pentacel (dptap+hib) is a relatively painless vaccine to administer whereas prevnar (conjugated pneumococcal vaccine) causes significant pain on injection and severe distress to the infant being vaccinated. for this reason, many vaccinators administer pentacel \[dpt\] prior to prevnar \[pcv\] when providing both vaccines in one visit. however, the difference in infant pain responses has not been documented. although it has been shown that very early pain events affect infants' later experience of pain, it has not been demonstrated that the sequence in which vaccines are administered affects pain response. this study will assess whether there should be a predetermined sequence recommended for administering these two vaccines, with the less painful vaccine (pentacel) being given first.

Eligibility criteria:
inclusion criteria: * healthy infant * 2 - 6 months of age * receiving primary dpt and pcv vaccinations exclusion criteria: * chronic illness * immune deficiency * immunosuppression * a history of allergy to dpt or pcv or any of its components * fever * any acute illness that prevents the administration of the vaccine

Keywords: vaccination pediatrics pain
glp-1 cellbeads® for the treatment of stroke patients with space-occupying intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage (ICH)

Summary: the objective of this study is to assess the safety of glp-1 cellbeads® in patients with space-occupying intracerebral hemorrhage.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ich by cranial computed tomography (cct) or magnetic resonance tomography (mrt) * patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects * age greater or equal 18 years for men * age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start) * for all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start * minimum hematoma diameter of 2 cm as measured in baseline cct or mrt * signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent exclusion criteria: * participation in any other clinical trial within the past 3 months or ongoing * occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion hemorrhage secondary to tumour or trauma * patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem * patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome * allergy to contrast media (mrt) * acute infection * muscular, neurological, or vascular insufficiency of the respective tissue * polypropylene incompatibility * acute immunosuppressive medication * patient after organ transplantation * patient with immune depression * patients with a high probability of spontaneous recovery or showing rapidly improving signs * patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots * patients whose diagnosis of ich is uncertain
vibration response imaging in healthy subjects

Conditions: Healthy

Summary: the primary purpose is to test intersubject variability and establish the qualitative features of normal vri images and the range of normality of the vri quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. our hypothesis was that vri breath sound images of healthy subjects are similar in a qualitative and quantitative manner.

computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.however, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment. the vri provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.

Eligibility criteria:
inclusion criteria: * able and willing to read, understands, and provides written informed consent; * male or female in the age range of 18-85 years; * subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months; * subject has normal chest x-ray and normal lung function during the past 6 months that were judged stable; * bmi \> 21. exclusion criteria: * subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition; * subject has a chest cage deformation; * subject has spine deformation (including severe scoliosis); * subject is hirsute; * subject has a skin lesion (potentially contagious) on the back; * subject has a cardiac pacemaker or implantable defibrillator;

Keywords: healthy lung sounds breath sounds
an online physical activity coaching intervention for people with pd in qatar

Conditions: Parkinson Disease

Summary: regular exercise can improve function and quality of life as well as have other positive behavioral and health-related benefits in people parkinson's disease (pd). despite the benefits, insufficient exercise is common among pd individuals, often due to common barriers, emphasizing the importance of empowering individuals with adequate knowledge and self-management skills. this project aims to develop "engage-qatar pd," an online physical activity self-management program for people with pd in qatar. engage-qatar pd will be grounded in a previously developed coaching intervention used in people with huntington's disease (engage hd) and people with pd. the main focus of this project will be the development work to adapt this intervention for online delivery for people with pd and within the qatari context. this development stage will entail participatory design, in which users will be actively involved as co-designers to ensure fully the required cultural adaptations. following this development phase, a pilot randomized controlled trial will be conducted to assess the feasibility, acceptability, and potential benefits of the developed intervention. the innovative approach proposed for this project would have wide-reaching impact, advancing the development of new therapeutic options. it will deliver a realistic, culturally adapted therapeutic option for people with pd in qatar that has the potential to be implemented in a variety of healthcare settings and other countries in the region. importantly, future work could replicate this program in a larger cohort of individuals with other neurodegenerative diseases and extend this work to other countries in the region.


Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. successful completion of physical activity readiness questionnaire (par-q), or medical clearance from a neurologist. 3. ambulatory for indoor and outdoor mobility with or without an assistive device but without physical assistance. 4. a neurologist-confirmed diagnosis of pd. 5. ability to follow study-related commands. exclusion criteria: 1. musculoskeletal injury or a medical condition that would prevent safe participation in an exercise program including failure to pass the par-q test. 2. the presence of any other neurological conditions. 3. acute illness or injury that prevents participation in the intervention.

Keywords: pd: parkinson's disease pa: physical activity ndd: neuro degenerative disease qri: qatar rehabilitation institute
progressive muscle relaxation and adaptation to old age

Conditions: Elderly Women

Summary: changes and limitations in the aging process affect adaptation to old age. it is important for women to adapt to the problems of old age, find a solution and cope. this study was aimed to determine the effect of progressive muscle relaxation exercises on the level of depression and adaptation to old women.

the aging process is considered as a result of the decline observed in basic cognitive functions such as attention, perception, memory, and causes problems in the communication of the elderly with the environment. for these problems, it affects the adaptation of the elderly in his environment and himself. there are a limited number of studies in the literature to increase the adaptation of older individuals to old age. in the studies in the literature, it was stated that the rate of depression is higher in female individuals, and being male and having a high education level positively affect the adaptation of individuals to old age. in a national study, it was determined that as age increases, adaptation to old age decreases. progressive muscle relaxation (pmr), one of the nonpharmacological methods, involves the voluntary stretching and relaxation of large muscle groups (hand-starting, foot-end muscle groups) in the human body. it is known that pmr exercises are frequently used in nursing research because of the effects of reducing anxiety and fatigue and improving sleep quality, and reducing nausea-vomiting. however, no study was found on the effect of depression and adaptation to old age. due to these positive effects of pmr determined in the literature, it is thought that elderly women can positively affect their levels of depression and adaptation to old age. objective: evaluate the effects of progressive muscle relaxation on the depression and adaptation of elderly women to aging. methodology: this is randomized clinical test. the sample was made up of 49 elderly women who applying to the family health center (21 in the experimental group and 28 in control group). the progressive muscle relaxation was employed. in order to collect the data, we adopted the interview with form filling technique, using the introductory information form, assessment scale of adaptation difficulty for the elderly (asade) and geriatric depression scale short form (gds-s). progressive muscle relaxation will be performed for a total of 8 weeks, 3 days a week, for 30 minutes.

Eligibility criteria:
inclusion criteria: * 65 years and above, * do not have a diagnosis of dementia and psychiatric disease by the doctor and have a mini-mental test score of 23 and above, * being independent in practicing daily living activities * there is no problem with communication exclusion criteria: * under the age of 65 * being addicted in daily life activities * being diagnosed with dementia and psychiatric illness * mini-mental test score below 23

Keywords: relaxation exercises elderly women adaptation to old age
two-year research study investigating how well semaglutide works in people suffering from overweight or obesity

Conditions: Overweight; Obesity

Summary: this study will look at the change in body weight from the start to the end of the study. researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. in addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. participants will need to take 1 injection once a week. the study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. the study will last for about 2 years. the participants will have 19 clinic visits and 15 phone calls with the study doctor.


Eligibility criteria:
inclusion criteria: * male or female, age more than or equal to 18 years at the time of signing informed consent * body mass index (bmi) more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * history of at least one self-reported unsuccessful dietary effort to lose body weight exclusion criteria: * hba1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening * a self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
minimally invasive transthoracic device closure in perimembranous ventricular septal defect

Conditions: Perimembranous Ventricular Septal Defect

Summary: the purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. this is a multi-center randomized controlled trial. because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. therefore the results of this trial need to be system evaluated through objective methods to reduce bias.

several examinations need to be done in all the patients, including x-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. and they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). if the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass . recheck x-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. the patients were followed up by x-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.

Eligibility criteria:
inclusion criteria: * age≥3 months * patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. diameter of the defect is greater than 3mm, and less than 10mm exclusion criteria: * para adverse ventricular septal defect * muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect * patients with severe pulmonary hypertension in right-to-left shunt * patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation * infective endocarditis, and heart cavity neoplasm * patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period
pulsed radiofrequency of s2-4 versus ganglion impar neurolysis for severe perianal and perineal pain in cancer patients

Conditions: Analgesia

Summary: perineal pain resulting from malignancy is usually severe. pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.

perineal pain resulting from malignancy is usually severe. pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. ganglion impar block has been traditionally used for treatment of such perineal pain. radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years * asa ii-iii with perianal and perineal pain related to cancer exclusion criteria: * patient refusal * coagulation defects * abnormal kidney or liver functions * local infection at site of injection
efficacy of aripiprazole versus placebo in the reduction of aggressive and aberrant behavior in autistic children

Conditions: Autism

Summary: hypothesis: (1) aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the aberrant behavior checklist-irritability subscale. (2) aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity. the purpose of this study is to examine the possible benefit of the medication aripiprazole in autistic individuals.

aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like aripiprazole. this study aims at assessing the effect of aripiprazole vs. placebo treatment on symptoms of irritability and aggression associated with autism, as well as the effect on the global severity of child and adolescent autistic disorder. children or adolescent outpatients, with age ranges from 5-17, will be enrolled into an 8-week placebo controlled, double blind treatment study. during the 8 weeks, patients will be monitored by the treating psychiatrist. study assessments will be administered at designated time points.

Eligibility criteria:
inclusion criteria: * meets dsm-iv, adi-r criteria for autistic disorder. * age 5-17 years. * outpatients * parent or legal guardian willing to sign informed consent. exclusion criteria: * subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression). * subject has caused visible harm to him/herself. * subject has an active seizure disorder or epilepsy (seizures within the past year). * subject has an unstable medical illness, including heart disease. * subject has experienced brain injury. * subject has a history of diabetes. * subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies. * subject has a history of prior treatment with aripiprazole of 5 mg/day or higher for 6 weeks. * subject lives in a far away area and/or does not have regular access to transportation to the clinical facility. * subject is a pregnant female or unwilling to use acceptable contraception if sexually active.

Keywords: aggression irritability global autism severity
study evaluating ascending single-dose of bosutinib administered with multiple doses of ketoconazole to healthy subjects

Conditions: Breast Cancer; Tumors; Leukemia

Summary: the purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.


Eligibility criteria:
inclusion criteria: 1. men or women of nonchildbearing potential (woncbp) aged 18 to 50 years inclusive on study day 1. woncbp may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[fsh\] ≥ 38 miu/ml) and must have a negative serum pregnancy test result before administration of test article. 2. body mass index (bmi) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg. 3. healthy as determined by the investigator on the basis of screening evaluations. exclusion criteria: 1. family history qt prolongation, syncope, seizure, or unexplained cardiac related death. 2. presence or history of any disorder that may prevent the successful completion of the study. 3. any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.