Kornimate/medical-research-clean huggingface dataset:
even-up to minimize secondary site pain for ankle fracture

Conditions: Arthralgia; Trouble Balancing

Summary: evaluating impact of use of even-up shoe wear device for patients treated in cam boot walker for an ankle fracture. randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with even-up device on contralateral extremity.

a variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (cam) walker boot. cam walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. such qualities lend the cam walker boot to provide ankle support that can be advantageous compared with other commonly used methods. despite their utility, cam walker boots create a simulated leg-length discrepancy (lld), which can result in altered biomechanics during ambulation. additionally, a lld can be associated with lower back and joint pain. we have previously conducted a study that suggests a relationship exists between cam walker boot treatment and pain at sites other than the extremity being treated. there have been several randomized controlled trials (rcts) examining a relationship between the correction of inherent lld with insole inserts and lower back pain. furthermore, there has been a past rct and there is a current rct examining a relationship between the use of the evenup orthotic shoe lift to correct cam walker boot simulated lld and pain at sites other than the extremity being treated. however, these studies were not conducted with patient populations with uniform injuries. to the best of our knowledge, an rct has not been conducted with the evenup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. this rct aims to assess the efficacy of the evenup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.

Eligibility criteria:
inclusion criteria: * non-operative treatment of ankle fracture * cam boot as treatment for injury * weight bearing ad lib exclusion criteria: * pregnancy * non-english speaking * recent surgery for lower extremity or back * recent other injury to lower extremity or back * restricted weight bearing

Keywords: joint pain ankle fracture leg length discrepancy cam boot even-up
effects of breathing training on psychosocial functioning and heart rate variability in postmenopausal women with depressive symptoms

Conditions: Postmenopause

Summary: the specific aims of this study are: 1. to develop a breathing training protocol specifically designed to improve hrv and psychosocial functioning for postmenopausal women with depressive symptoms, 2. to examine the immediate effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, 3. to examine the intermediate-term effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, and 4. to determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in hrv.

postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. they are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. we expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.

Eligibility criteria:
inclusion criteria: * permanent termination of menstruation of natural cause. * cessation of menstrual cycles for more than 12 consecutive months. * a score of the chinese version of beck depression inventory-ii of greater than 10. * able to speak mandarin or taiwanese. * age from 45 to 64 years. exclusion criteria: * subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency. * subjects who received hormone replacement therapy prescribed by gynecological physicians. * subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions

Keywords: depression depressive symptoms postmenopause rsa biofeedback
mainstream sleep tracking devices vs polysomnography

Conditions: Severe Sleep Apnea; Severe Insomnia; Epileptiform Activity

Summary: the purpose of this study is to compare two popular portable sleep monitoring devices-the fitbit charge®, jawbone up®, and sleeptime smartphone app-to the "gold standard" polysomnography (psg). parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. specifically, this study will investigate the validity of the jawbone up®, fitbit charge®, and sleeptime app in detecting sleep and wakefulness in comparison to conventional polysomnography (psg).


Eligibility criteria:
inclusion criteria: * patients undergoing polysomnography exclusion criteria: * severe sleep apnea * severe insomnia with less than two hours of sleep per night * epileptiform activity * electrical status epilepticus of sleep
a trial of azithromycin sr for the treatment of laryngopharyngitis or tonsillitis or acute bacterial rhinosinusitis

Conditions: Upper Respiratory Tract Infection

Summary: to evaluate the clinical efficacy and safety in patients with laryngopharyngitis or tonsillitis or acute bacterial rhinosinusitis receiving a dose of 2 g of azithromycin in the sr formulation.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed laryngopharyngitis or tonsillitis or acute bacterial rhinosinusitis exclusion criteria: * severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
prenatal care program in dingyuan county

Conditions: Prenatal Care

Summary: the general objective of this study is to evaluate prenatal care in the specific context of rural china. it also aims to define the optimal content of prenatal care for the context of rural china, to evaluate the effect of such prenatal care on infant and maternal outcomes, using a community based, well designed controlled trial in rural counties. finally, it aims to describe the process of conducting a controlled study using community resources.

the study was conducted in a rural county of 900,000 people in anhui province, in eastern china. the total area of the county is almost 3,000 square kilometres. the majority of the population of the county is engaged in farming. in terms of national gdp rankings, the study county is typical of less developed rural areas in china. twenty townships (10 interventions and 10 control) out of a total of 55 were selected - on the basis of having sufficient health facilities and staff - for a controlled trial on the introduction of systematic prenatal care in the area.

Eligibility criteria:
inclusion criteria: * pregnant woman in program area (in 20 townships) from august 2000 to march 2003 exclusion criteria: * outsiders of program area

Keywords: prenatal care community-based randomized controlled trial perinatal mortality china
extension study of pegylated somatropin to treat growth retardation caused by endogenous growth hormone deficiency in children

Conditions: Growth Retardation

Summary: 1. to further evaluate the safety and efficacy of peg-somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. to explore the factors influencing the efficacy of peg-somatropin and to establish the height prediction model based on chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of peg-somatropin.


Eligibility criteria:
inclusion criteria: * children has completed all visits and therapy in previous phase iv study; * investigators evaluate subjects could continue growth hormone therapy; * subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. exclusion criteria: * children with epiphyseal closure; * children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys; * dysfunction of liver and kidney (alt\> 2 times the upper limit of normal, cr\> upper limit of normal); * patients with known hypersensitivity to peg-somatropin or somatropin or any other components of the study product; * patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * patients with diabetics; * patients with congenital bone dysplasia or scoliosis; * patients took drugs that would influence the efficacy and safety of peg-somatropin after phase iv study and before screening for this extension study; * other conditions in which the investigator preclude enrollment into the study.
quality and biologic characteristics of red blood concentrates obtained from individuals with elevated ferritin.

Conditions: Hereditary Hemochromatosis; Hyperferritinemia

Summary: iron overload in hereditary hemochromatosis (hh) is treated by phlebotomy. it is unclear, if individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes are suitable as blood donors. the study investigates hemolysis and several other quality parameters of red blood cell concentrates (rbc) obtained from 80 individual with ferritin \>500 ng/ml - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control.

iron overload in hereditary hemochromatosis is treated by phlebotomy. in switzerland and in many other coutries, these individuals are not accepted for blood donation until ferritin values and phlebotomy intervals are in the normal range. individual with secondary hyperferritinemia, e. g. related to metabolic syndrome, are accepted as blood donors according to their clinical situation. it is unclear if the quality of blood products issued from individuals with hyperferritinemia due to hereditary hemochromatosis or to secondary causes is comparable with the quality of those issued from healthy blood donors, and if their characteristics comply with the international standards. the study investigates the hemolysis rate and several other quality parameters in rbc obtained from 80 individual with ferritin \>500 ng/ml - due to hereditary hemochromatosis or secondary - and 20 healthy blood donors as control. for this purpose, whole blood donations are manufactured according to the standard processes applied in the blood bank. several standard quality parameters as well as biologic, rheologic, and oxydative stress-related variables are measured and compared, both with the current regulations and with those of the control group.

Eligibility criteria:
inclusion criteria: * age:18-75 years * body weight \> 50 kg * haemoglobin ≥ 135 g/l (males), ≥ 125 g/l (females) * in subjects of the hh and non-hh group: ferritin values \>500 ng/ml, which must have been measured in the last three months before the inclusion in the study (either at the blood donation service or elsewhere), not followed by a blood donation or a phlebotomy * in subjects of the hh group: genetic test demonstrating the presence of p.c282y homozygous or p.c282y/p.h63d compound heterozygous hfe-gene mutation * in subjects of the control group: ferritin values \< 300 ng/ml (males) or \< 200 ng/ml (females) * written informed consent to the participation in the study exclusion criteria: * inadequate vein access for whole blood collection * body weight \< 50 kg * chronic viral infection (hepatitis b or c, hiv) * previous acute coronary heart disease * previous or current history of epilepsy * other severe conditions that could significantly increase the phlebotomy risk, based on individual medical evaluation * no informed consent * pregnancy (according to the information on the standard blood donor questionnaire)
can instrumentation kinematics affect post operative pain and substance p levels? a randomized controlled trial

Conditions: Pain, Postoperative; Irreversible Pulpitis; Apical Periodontitis

Summary: the aim of this study was to evaluate the effect of continuous rotation and reciprocation kinematics on post operative pain and difference in substance p levels in patients with irreversible pulpitis with symptomatic apical periodontitis. twenty patients were randomly distributed into two groups; continuous rotation group(n=10): received mechanical preparation using edgeendo x7 rotary system (albuquerque, new mexico, usa), while reciprocation group(n=10): received mechanical preparation using edgeone fire reciprocating system (albuquerque, new mexico, usa). apical fluid(af) samples were collected, and substance p (sp) levels were measured using radioimmunoassay and postoperative pain was measured using numerical rating scale (nrs) preoperatively, at 6h, 12h, 24h, 48h and 72h.


Eligibility criteria:
inclusion criteria: * single rooted mandibular second premolar teeth with complete root formation * pulpal diagnosis: symptomatic irreversible pulpitis * periapical diagnosis: symptomatic apical periodontitis with no visible periapical radiolucent area * patients with pre-operative pain records above 4 on numerical rating scale (nrs) to ensure standardization exclusion criteria: 1. the presence of any systemic disease or allergic reactions 2. pregnant and lactating females 3. patients on antibiotic or anti-inflammatory medication 4. use of analgesics a week prior to treatment 5. a radiographically untraceable canal or an excessively curved root 6. the presence of periapical radiolucency or sinus tract. 7. teeth with open apices 8. severe periodontal disease (generalized or localized to the tooth in question) 9. absence of bleeding in the pulp chamber on access cavity preparation 10. internal or external resorption

Keywords: pain substance p continuous rotation reciprocation
assessment of the safety and efficacy of ciproxan-i.v. in daily clinical practice - analysis results from a post-marketing surveillance

Conditions: Infection

Summary: this study is a post-marketing surveillance in japan, and it is a local prospective and observational study of patients who have received ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. the objective of this study is to assess safety and efficacy of ciproxan in daily clinical practice. a total of 3,000 patients are to be enrolled and assessed during the period of treatment with ciproxan.


Eligibility criteria:
inclusion criteria: * patients who received ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug. exclusion criteria: * patients who are contraindicated based on the product label.

Keywords: ciprofloxacin sepsis infection pneumonia peritonitis cholecystitis cholangitis anthrax
clinical investigation of the effects of colgate total toothpaste as compared to a matching placebo on periodontal disease and systemic inflammatory markers

Conditions: Periodontal Disease; Systemic Inflammatory Markers

Summary: this is a single center, double blinded, randomized, controlled trial. qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.

the objective of this study is to comparatively evaluate the effects of colgate total® toothpaste with triclosan (commercially sold in israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. periodontal parameters (periodontal pocket dept (ppd), clinical attachment loss (cal)) will be assessed at baseline and after 2, 6 and 12 months of product use. peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (crp, pge2, il-1β, tnf-α).

Eligibility criteria:
inclusion criteria: 1. subject males or females 18 to 50 years old. 2. availability for the 12 months duration of the clinical research study. 3. subject able and willing to follow study procedures and instructions. 4. subject read, understood and signed an informed consent form. 5. subject present with at least 20 natural teeth in the functional dentition (excluding third molars). 6. initial probing pocket depth of \>4mm in at least one tooth/quadrant. 7. good general health. 8. subjects willing to disclose information on medication. exclusion criteria: 1. subject with concomitant periodontal therapy 6 months prior to enrollment. 2. subject with orthodontic appliances. 3. subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination\*. 4. subject treated with antibiotics within 3 months prior to enrollment. 5. subject necessitating antibiotic prophylaxis. 6. subject with active infectious diseases (hepatitis, human immunodeficiency virus or tuberculosis) or subject is immunocompromised as determined by the investigator\*. 7. subject with known allergy to oral care products or ingredients in oral care products. 8. subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner). 9. subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis. 10. participation in any other clinical study or test panel within the one month prior to entry into the study. 11. subject pregnant at point of enrollment.
popcorn lung: the discovery of a new disease

Conditions: Lung Diseases, Interstitial; Bronchiolitis Obliterans

Summary: recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn factory in jasper, missouri. the exposure agent has not yet been identified, but suspects include butter flavoring and the powdered salt used in the mixing room. this disease resembles "bronchiolitis obliterans syndrome", an illness that makes it difficult to breathe. of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room or in the microwave packaging area have had decreases in lung function seven times the norm for their age. industrial hygiene experts revealed that dust concentrations of salt and other flavorings were much higher in the mixing room compared to the office and outdoor work areas. recently, rats were exposed to vapors created by heating the butter flavor compound obtained from this plant. six-hour exposure to vapors at very high concentration resulted in significant damage to the breathing apparatus. thus, there is clinical, epidemiological, and animal toxicity data that appears to implicate some constituent present during the mixing of the butter flavoring, salt, and oil causing a form of obstructive airway disease that has been rapidly progressive in a number of workers. it is not clear what the pathophysiologic nature of this entity is, though it resembles bronchiolitis obliterans syndrome. it is not known what the long term consequence of this will be on the active workers, nor is it clear whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the plant are going to be effective.


Eligibility criteria:
current employees who have a decline in fev1 larger than 200cc within the past year will be eligible to participate. all index cases will be eligible to participate.
phase iv clinical study of pegylated somatropin (peg somatropin) to treat growth hormone deficiency children (clinical trial i)

Conditions: Growth Hormone Deficiency

Summary: this study evaluates the safety and efficiency of pegylated somatropin (peg somatropin) injection in the treatment of endogenous growth hormone deficiency (ghd) in the broad of population of children.


Eligibility criteria:
inclusion criteria: * before starting treatment, according to the medical history, clinical symptoms and signs, gh stimulation test and imaging examination, patients are diagnosed as ghd. * according to the height statistical data of chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender. * height velocity (hv) ≤5.0 cm/yr. * gh stimulation test with two different mechanisms affirms that gh peak concentration of patients' plasma\<10.0ng/ml. * bone age (ba) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (ca). * be in preadolescence (tanner stage 1) and have a ca ≧ 3 years. * receive no prior gh treatment within 6 months. * sign informed consent. exclusion criteria: * people with abnormal liver or kidney function (alt\> 2 times the upper limit of normal value, cr\> the upper limit of normal value). * patients positive for hepatitis b core antigen (hbc), hepatitis b surface antigen (hbsag) or hepatitis be antigen (hbeag). * people with known highly allergic constitution or allergy to the drug of the study. * people with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency. * diabetic. * potential tumor patients (family history). * abnormal growth and development, such as turner syndrome, constitutional delay of growth and puberty,laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome. * subjects took part in other clinical trial study within 3 months. * other conditions which in the opinion of the investigator preclude enrollment into the study.