Kornimate/medical-research-clean huggingface dataset:
study for mr formulation of pf-06650833 in healthy adult japanese subjects

Conditions: Healthy

Summary: the purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of pf-06650833 orally administered as modified release tablets in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: 1. healthy female subjects of non childbearing potential and/or male japanese subjects between the ages of 20 and 55 years, inclusive. 2. body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). 3. subject must have four japanese grandparents who were born in japan. 4. evidence of a personally signed and dated informed consent document. 5. subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: 1. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. 2. any condition possibly affecting drug absorption (eg, gastrectomy). 3. a positive urine drug screen. 4. smoking cigarettes with exceeding provided criteria. 5. history of regular alcohol consumption exceeding provided limitations. 6. treatment with an investigational drug within a provided criteria. 7. abnormal supine blood pressure. 8. abnormal pulse rate. 9. abnormal 12 lead ecg. 10. history of tuberculosis. 11. history of hepatitis or positive testing for hiv, hepatitis b surface antigen, hepatitis b surface antibodies, hepatitis b core antibodies, hepatitis c antibodies or syphilis. 12. any medical history of disease (ie, gilbert's disease). 13. abnormal clinical laboratory test related to cardiac and skeletal muscle injury. 14. male subjects with partners currently pregnant; unwilling or unable to use a highly effective method of contraception 15. use of prescription or nonprescription drugs, vitaminic and dietary supplements within a specified duration. 16. blood donation exceeding a provided limitation. 17. history of sensitivity to heparin or heparin induced thrombocytopenia. 18. history of cancer (other than treated basal cell and squamous cell carcinoma of the skin) in the previous 5 years. 19. unwilling or unable to comply with the lifestyle guidelines described in this protocol. 20. subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are pfizer employees directly involved in the conduct of the study. 21. other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
pain, anxiety of aromatherapy and music effect on

Conditions: Cancer

Summary: the research is planned as a randomized controlled trial. the main question\[s\] it aims to answer are: \[question 1\]: does the inhaler effect of music and aromatherapy applied to palliative care patients have an effect on pain, anxiety and vital signs? the individuals in the research group are divided into four groups as music group, aromatherapy group, music and aromatherapy and control group. . before and at the end of the intervention, data collection tools \[patient description form, visual analog scale,face anxiety scale, distress thermometer, edmonton symptom scale\] will record the characteristics of pain, anxiety and vital parameters. patient identification form: it is a questionnaire that includes sociodemographic characteristics (gender, age, educational status, income status, employment status and occupation) and questions about the disease, created by the researchers by scanning the literature.

the relaxing music group listened to specially composed "musicure®" compositions in soft rhythm, including melodies with harp, cello, strings and sound elements from nature (eg rain, bird, forest sound).the patients in the experimental group listened to music with headphones for 20 minutes for three consecutive days.pain, anxiety and vital parameters were recorded with data collection tools \[patient description form, vas, fas, distress thermometer, edmonton symptom scale\] before and at the end of the intervention.for the patients in the aromatherapy group, use 5% lavender oil with a diffuser for 15-20 minutes. has been applied.the diffuser was placed 30 cm from the participants and five (5) drops of essential lavender oil were placed on the filter paper. within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.the patients hospitalized in the palliative care service were given music with a loudspeaker for three consecutive days with the effect of aromatherapy inhaler. within 10-15 minutes after the completion of the inhalation, data collection forms were applied again and pain, anxiety, blood pressure, pulse and respiratory rate were evaluated.

Eligibility criteria:
inclusion criteria: * who volunteered to participate in the research, * 18 years and older, * no hearing problem * doesn't have any problems with smelling healthy, * no communication and speech problems exclusion criteria: * with a diagnosis of psychiatric illness, * allergic to lavender, perfumes or cosmetics, * having asthma and chronic obstructive pulmonary disease

Keywords: pallative care aromatherapy music therapy
neuromuscular and proprioceptive training in football players

Conditions: Football Players; Sport Injury; Sports Physical Therapy

Summary: the objective of this study was to determine the effect of proprioceptive and neuromuscular training on landing errors and balance of the football players. this was randomized controlled trial in which 40 football players were randomly allocated into experimental and control group. the control group followed conventional exercise plan while experimental group players were being trained under myklebust's training program. data were collected at baseline and after follow-up of five weeks landing error score system (less) and biodex single leg stability (sls) score. data were analyzed using statistical package for social sciences (spss)-21.

anterior cruciate ligament (acl) injuries are a severe public health issue from both an economic and general wellness view. this burden will be reduced by promoting compliance and the use of injury prevention programs. to reduce injury rates, trainers, athletes, parents, and the team of sports medicine need to know the advantages of injury prevention programs. parents and employees in sports medicine want a program that can decrease the risk of injury. coaches and athletes are looking for a program that will also increase athletic efficiency without taking time off exercise, time that would otherwise be spent honing sport-specific abilities. injury prevention programs in youth athletics will promote neuromuscular enhancements and create appropriate long-term techniques while instantly preparing the athlete for competition. various studies have been done to assess the role of proprioceptive and neuromuscular exercises on reducing incidence of acl injury. no conclusive result has been established as yet that these type of exercises really reduce the incidence of acl injury or not. however, it is found that by performing certain exercises there is improvement in biomechanics of jump landing as predicted by less score which is a reliable tool to establish risk of acl and other lower limb injury in an athlete. therefore the investigators have used a lower limb injury prevention program to assess its effectiveness in reducing less score.

Eligibility criteria:
inclusion criteria: * male football players registered with pakistan sports board, islamabad. * players playing for a minimum of 20 hrs per week. * the participant should understand and sign the informed consent form. * players should agree to take part in the training program for 35 days. exclusion criteria: * players with any major neuromusculoskeletal or cardiovascular pathology in last 6 months. * players having any psychological issue

Keywords: acl injury landing error score system neuromuscular training proprioceptive training soccer
validation of minimally invasive ultrasound indicator dilution technique in critically ill children

Conditions: Cardiac Output

Summary: a novel method to measure cardiac index based on ultrasound indicator dilution technology (uidt) has been developed by transonic systems inc. (ithaca, ny, usa). the method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children. in the proposed investigation, the investigators hope to validate a novel application of an existing technology in critically ill infants and children. the primary aim of this study is to determine the accuracy of cardiac index measured by uidt when compared to the gold-standard fick technique. the primary hypothesis is that the average of three consecutive measurements of cardiac index by uidt will be accurate when compared to the fick technique. secondary aims will be to determine the precision of the measurement, the feasibility of the technique with regards to time required and any complications encountered. an exploratory secondary aim of this study is to determine whether central blood volume (cbv) derived from indicator transit time (itt) correlates with central venous pressure (cvp) and echocardiography derived measures of preload.


Eligibility criteria:
inclusion criteria: * age: less than 18 years. * admission to the cicu (cardiac intensive care unit) (8s) or misicu (medical-surgical intensive care unit) (7s) of the children's hospital boston. * presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography. * requirement for mechanical ventilation via an endotracheal or tracheostomy tube. * presence of an arterial catheter. * patients must have a two ventricle circulation. exclusion criteria: * endotracheal tube leak of greater than 10%. * a significant air leak around the endotracheal tube makes vo2 impossible to measure. * presence of relevant intracardiac shunt. * intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable. * a patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study. * previous enrollment in an incompatible research study. * current or prior diagnosis of heparin induced thrombocytopenia. * a small amount of heparin is required to flush the extracorporeal av (arteriovenous) loop that is required for the measurements. * pneumothorax with ongoing air leak. * an air leak will invalidate the measurement of vo2.

Keywords: cardiac index ultrasound dilution accuracy of ultrasound dilution cardiac index.
the verismart trial

Conditions: Atrial Flutter

Summary: catheter ablation is now routinely used in the management of heart rhythm disorders. one of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. this is important because too much contact has safety implications and too little means that the therapy will be ineffective. recently two different technologies have been developed to determine contact. currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.


Eligibility criteria:
inclusion criteria: * age ≥18 years * documented paroxysmal or persistent atrial flutter exclusion criteria: * inability or unwillingness to receive oral anticoagulation * previous ablation procedure for afl * unwillingness or inability to complete the required follow up arrangements * concomitant atrial fibrillation
high protein diet on transcriptomic, metabolomics, hepatic and pancreatic fat anatomy and physiology in asian indians with pre-diabetes

Conditions: Pre-diabetes

Summary: diabetes/ prediabetes is a substantial problem in india not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. it is not clear if a high protein calorie diet in the indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. the analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. the proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.

this study will be conducted at the outpatient department of the national diabetes, obesity and cholesterol foundation (n-doc), diabetes foundation (india) (dfi)and fortis-c-doc, centre of excellence for diabetes, metabolic diseases and endocrinology, new delhi, india. experimental protocol: in this study, a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender-matched controls (age 18-40 years) will be recruited. they will be randomized to an equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) or a high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. all assessments as done on day 1 will be repeated at day 60.

Eligibility criteria:
exclusion criteria: * acute infections and advanced end-organ damage. * history of hepatitis or pancreatitis, abnormal liver and renal function tests. * recent (\<3 months) changes in weight (≥5%) and/or weight changing medications. * subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body. inclusion criteria cases: * age 18 to 50 years. subjects with pre-diabetes on oral glucose tolerance test (ogtt) * fasting blood glucose≥100mg/dl and \<126 mg/dl or 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 grams of anhydrous oral glucose) or both. controls: * age 18 to 50 years. normoglycemia by ogtt * fasting blood glucose \<100mg/dl and 2-h plasma glucose \<140mg/dl (after ingestion of 75 gram of anhydrous oral glucose).
efficacy of photodynamic therapy and laser disinfection in periodontal therapy for treatment of periodontitis

Conditions: Periodontitis

Summary: the goal of this clinical trial is to investigate the clinical and microbiological efficacies of laser disinfection and icg-mediated apdt as adjunct to rsd for patients with periodontitis. the main question it aims to answer is: does the use of laser disinfection or icg-mediated apdt as adjunct to rsd are effective in improving clinical parameters and reducing the load of periodontal pathogens. participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline. all patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids. all the patients will be instructed to attend again after 7 days. one week later, sites randomly allocated to control (ctrl) group and test groups which will receive, in addition to rsd, either apdt or periodontal pocket disinfection (biolase). for all groups, sites with initial ppd 4-6 mm will be treated with rsd using area specific (graecy) curettes.


Eligibility criteria:
inclusion criteria: * adult subjects (\>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. all patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (anterior teeth and premolars) with 4-6 mm ppd and positive bop. periodontitis cases will be defined by presence of interdental cal affecting ≥2 non adjacent teeth or if cal at buccal/lingual aspects associated with ppd \>4mm at ≥2 teeth. exclusion criteria: * patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded.
inactive fsh in galactosemia

Conditions: Galactosemia; Premature Ovarian Failure

Summary: the aim of the study is to investigate whether inactive fsh plays a role in the development of premature ovarian failure in women with classic galactosemia


Eligibility criteria:
inclusion criteria: * diagnosis of galactosemia through galt-activity analysis and/or mutation analysis * premature ovarian failure with fsh \> 30 u/l exclusion criteria: * gynecological cancers and/or unexplained vaginal bleeding
efficacy and safety of lcz696 200 mg + amlodipine 5 mg in comparison with amlodipine 5 mg in hypertensive patients not responding to amlodipine

Conditions: Essential Hypertension

Summary: this study will assess whether lcz696 when used in combination with amlodipine will provide greater bp lowering benefit compared to amlodipine alone in asian hypertensive patients not adequately responsive to amlodipine therapy.


Eligibility criteria:
inclusion criteria: patients must give written informed consent and have a diagnosis of hypertension: untreated patients must have an mssbp ≥ 150 mmhg and \< 180 mmhg at both visit 1 and visit 101. pre-treated patients must have an mssbp ≥ 145 mmhg and \< 180 mmhg after wash out at visit 101. all patients must have an office mssbp ≥ 145 mmhg and \< 180 mmhg at the completion of the 4-week run-in epoch (at the randomization visit (visit 201). patients must successfully complete abpm and pass technical requirements at visit 201. exclusion criteria: malignant or severe hypertension (grade 3 of who classification; msdbp ≥110 mmhg and/or mssbp ≥ 180 mmhg). history of angioedema, drug-related or otherwise. history or evidence of a secondary form of hypertension. transient ischemic cerebral attack (tia) during the 12 months prior to visit 1 or any history of stroke. history of myocardial infarction, coronary bypass surgery or pci during the 12 months prior to visit 1 other protocol-defined inclusion/exclusion criteria may apply

Keywords: essential hypertension high blood pressure
the right intervention for the right patient

Conditions: Low Back Pain

Summary: complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.it is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention. we would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.

two quality assurance investigations are performed in the the back research center clinic, where one is published in the spine. the systematics of health technology assessment was used to throw light on important indicators in relation to health technology aspects, patient aspects, organisational aspects and economical aspects. at 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. in 2004 in a new investigation this fraction was larger. therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory. a norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. conversely the mono disciplinary intervention had best effect on the least severe patient group. therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs. even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity. * mainly biological * both biological and psychological * both biological and social * both biological, psychological and social it is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. it is important to take into account all three elements, the severity of the elements, and the combination of elements. to be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.

Eligibility criteria:
inclusion criteria: * unspecific low back pain * level of low back pain must be at least equal to leg pain * patients must have been sick listed during the past 12 months * age \> 17 years and \< than 60 exclusion criteria: * modic changes as seen on mri * direct or progressive paresis or cauda equina syndrome * known mb bechterew or sacroiliitis * suspicion of other serious malignancy * alcohol or medicine abuse * a screening result of more than 30 in the beck depression inventory

Keywords: low back pain return to work biopsychosocial screening sms non specific low back pain