Kornimate/medical-research-clean huggingface dataset:
oral health and people with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the public health impact of this study will be the application of the greater understanding of the oral health status, oral health related behaviors, and quality of life of patients with systemic sclerosis (scleroderma or ssc). it is hoped that risks and protective factors can be identified to be associated with the oral health status of adults with systemic sclerosis,leading to the development of interventions for improved oral health in this population,and providing the basis for a larger study of oral health problems of adults with systemic sclerosis.

the broad, long-term objective of our proposed research is to understand the oral health status, oral health-related behaviors, and quality of life in the us population of patients with systemic sclerosis (scleroderma or ssc). ssc is a rare, progressive connective tissue disease that affects predominately women (3.8:1) with a higher risk of the severe form among african-americans. ssc adults experience manifestations of the systemic disease that include microstomia, xerostomia, and impaired manual dexterity. the two specific aims of this study are: 1) to characterize the oral health status of adults with ssc, and 2) to determine the ssc disease specific manifestations (microstomia, xerostomia, and manual dexterity impairments) that are associated with the severity of oral health problems and oral health-related quality of life among adults with ssc. this first study of us adults with ssc is a cross-sectional survey of 250 adults with ssc in south carolina. this population is 25% african-american which is similar to the racial distribution of ssc in the us adult population. data collection includes information on: oral health status (periodontal, dental, mucosal and microbial), oral manifestations of ssc (size of oral aperture, severity of oral dryness, and manual dexterity for oral hygiene), and oral health-related behaviors and quality of life. the oral health status of the south carolina ssc population will be compared to that of the adult us population based on an analysis of corresponding measures using the national health and nutrition examination survey 1999-2002 data. multivariable regression modeling will be used to evaluate hypothesized risk and protective factors that are associated with oral health status in adults with ssc. results of this study in south carolina will be used in regional efforts for the development of interventions for improved oral health status of adults with ssc. second, these results will provide the basis for a larger us study of oral health problems of adults with ssc.

Eligibility criteria:
inclusion criteria: * diagnosis of ssc according to american college of rheumatology criteria, and participants are 18 years of age or older at the time of invitation to the study. exclusion criteria: * participants who require antibiotic medication before dental treatment

Keywords: oral health
glucocorticoid long-term administration: effect on cold induced energy expenditure and resting metabolic rate

Conditions: Thermoregulation Impairment

Summary: the aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.

brown adipose tissue (bat) is a thermogenic tissue that can convert chemical energy directly into heat due to the expression of uncoupling protein 1 (ucp1) protein. data from preclinical studies shows that glucocorticoids (gcs) inhibit the function of bat. in clinical practice gcs are often administered due tue their antiinflammatory properties making the investigation of short term (e.g. one week) and long therm (several months) effects practically relevant. this study's objective is to evaluate the effect of glucocorticoid treatment on cold induced thermogenesis (cit) in humans.

Eligibility criteria:
inclusion criteria: * planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group a) * planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group b) * bmi 19-30 kg/m2 * informed consent as documented by signature exclusion criteria: * insufficient thyroid hormone substitution in case of hypothyroidism * uncontrolled diabetes mellitus (hba1c \>7.5%) * severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer * known hypersensitivity to cold, e.g. primary or secondary raynaud's syndrome * known or suspected non-compliance * abuse of alcohol or illicit drugs * claustrophobia * women who are pregnant or breast feeding * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc of the participant * previous enrolment into the current study * enrolment into another study using ionizing radiation within the previous 12 months

Keywords: glucocorticoids brown adipose tissue cold induced thermogenesis resting metabolic rate
high tibial osteotomy for osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: a prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a puddu plate. the clinical outcome and radiological results were examined at one year.

a prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a puddu plate. the clinical outcome and radiological results were examined at one year. the primary outcome measure was the achievement of an overcorrection of valgus of 4°. secondary outcome measures were the severity of pain (visual analogue scale), knee function (hospital for special surgery score), and walking distance.

Eligibility criteria:
inclusion criteria: * radiological oa, medial joint pain and varus malalignment exclusion criteria: * symptomatic oa of the lateral compartment, rheumatoid arthritis, rom \ 10 degrees.
a clinical trial to evaluate the tolerability and pharmacokinetics of ckd-348(5)

Conditions: Hypertension and Dyslipidemia

Summary: a phase i clinical trial to evaluate the tolerability and the pharmacokinetics of ckd-348(5).


Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19 years. 2. body weight ≥55kg with calculated body mass index (bmi) of 18 to 30 kg/m2 3. those who meet the blood pressure criteria during screening tests: * systolic blood pressure: 90 to 139 mmhg * diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ecg results at screening. 6. those who agree to contraception during the participation of clinical trial. 7. those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. exclusion criteria: 1. those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products. 3. those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 4. those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products. * alcohol: man - 21 glasses/week, woman - 14 glasses/week (1 glass: soju 50ml, wine 30ml, or beer 250ml) * smoking: 20 cigarettes/day 6. those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. 7. those who have genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. 8. those who are deemed insufficient to participate in this clinical trial by investigators. 9. woman who are pregnant or breastfeeding.
phonomotor treatment of word retrieval deficits in individuals with aphasia

Conditions: Aphasia

Summary: this is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. the name of this disorder is called 'aphasia'. individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

the study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. all participants received the same treatment protocol (described in detail in appendix a and in minkina et al. (under review)). in order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (figure 2). participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. during the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy). standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.

Eligibility criteria:
inclusion criteria: * left hemisphere stroke * monolingual english speaking * right handed * presence of aphasia exclusion criteria: * preexisting neurological condition
use of rosiglitazone in the treatment of endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.

there is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial. comparison: following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. efficacy comparisons will be made utilizing visual analog scale diaries, short-form mcgill pain questionnaires and physical component summary scores of the sf-36. secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.

Eligibility criteria:
inclusion criteria: * healthy women ages 18 - 45 years. * regular menstrual cycles (24-35 days). * pelvic pain ≥ 3 months with cyclical component. * negative pregnancy test and must use nonhormonal contraception. * non-lactating. * no history of liver disease. * consent to participate in the study. * endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation within the past 4 years. exclusion criteria: * major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures. * active or prior infection with hepatitis, human immunodeficiency virus (hiv) infection, or history of high-risk activities (e.g., iv drug abuse) which would increase risk to laboratory personnel. of note, no testing for hepatitis or hiv will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected. * patients with liver dysfunction (elevated liver enzymes \> 2 times the upper limit of normal). * presence of pre-existing malignancy, including carcinoma of the breast or uterus. * women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric. * elevated wbc. * nyha functional class i-iv heart failure. * diabetics. * known pregnancy or positive pregnancy test.

Keywords: peroxisome proliferator-activated receptors treatment of endometriosis
evaluation of the proliferative activities of insulin analogues in primary human tumor cells

Conditions: Endometrial Cancer; Colon Cancer

Summary: recently the general medical literature has become aware that the use of certain long-acting insulin analogues could potentially increase cancer risk.during the last few years the investigators group generated information of both scientific and clinical relevance on the proliferative and anti-apoptotic actions of insulin analogues. the goal of this project is to evaluate the hypothesis that the proliferative and signalling activities elicited by insulin analogues may have a impact on tumor behavior. in this study the investigators will asses the biological actions of insulin analogs in primary tumor cells of endometrial and colon cancer.


Eligibility criteria:
inclusion criteria: * patients with endometrial and colon cancer exclusion criteria: * none

Keywords: to asses the biological actions of insulin analogs in primary tumor cells
acamprosate vs. placebo in bipolar alcoholics

Conditions: Alcohol Dependence; Bipolar Disorder

Summary: to conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. the study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo. the primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. a secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.


Eligibility criteria:
inclusion criteria: 1. adults ages 18-65 2. meet dsm-iv criteria for current (past 90 days) alcohol dependence 3. meet dsm-iv criteria for bipolar i or bipolar ii disorder 4. currently on a mood stabilizing medication regimen, including the use of lithium, valproic acid, lamotrigine, carbamazepine, and/or antipsychotic agent fda approved to treat bipolar disorder without any dosage adjustments in the past 30 days 5. must be able to remain free from alcohol for at least 3 days prior to medication initiation 6. subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments 7. subjects must consent to random assignment and be willing to commit to medication treatment and follow-up assessments exclusion criteria: 1. individuals with a primary psychiatric disorder other than bipolar disorder 2. individuals with an uncontrolled neurologic condition that could confound the results of the study 3. individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety 4. participants with creatinine clearance less than or equal to half of normal value as indicated by chem. 7 results conducted at screening visit. 5. concomitant use of other psychotropic medications not allowed per the protocol 6. women of childbearing potential who are pregnant, lactating or refuse to use adequate forms of birth control 7. current suicidal or homicidal risk 8. baseline scores of \> 35 on the montgomery asberg depression rating scale and/or \> 25 on the young mania rating scale

Keywords: acamprosate alcoholism bipolar disorder comorbidity craving depression gaba glutamate mania pharmacotherapy withdrawal
effect of functional massage in neuromuscular response.

Conditions: Neuromuscular Diseases

Summary: the study compares the effects of two types of massage: a conventional massage and a functional massage, in the neuromuscular response of the gastrocnemious muscles.


Eligibility criteria:
exclusion criteria: * muscle injury in the last two months * to not understand the study orders * suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Keywords: functional massage conventional massage neuromuscular response
effect of virtual reality on tmd following maxillofacial surgery

Conditions: Temporomandibular Disorder

Summary: sixty eight patients who have tmj pain and rom restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ). will be randomly divided into two equal groups ( group a, group b ). their ages range from 20 - 35 years. the purpose of the study is to evaluate the therapeutic efficacy of vr in decreasing pain and improve rom for patients after maxillofacial surgery.

sixty eight patients who have tmj pain and rom restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ). will be randomly divided into two equal groups ( group a, group b ). their ages range from 20 - 35 years. the vr glasses which were the source of visual and auditory feedback, were connected by bluetooth to a mobile phone and all the videos of selected tasks (tasks of active mobility exercises and isometric contraction exercises, massage exercises) were turned on. active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times of 5 s). * self-massage masticatory muscles, after each session. * isometric contraction exercises the purpose of the study is to evaluate the therapeutic efficacy of vr in decreasing pain and improve rom for patients after maxillofacial surgery.

Eligibility criteria:
inclusion criteria: * the subject selection will be according to the following criteria: * patients after arthrocentesis . * patients after temporomandibular joint condylar discopexy. * age ranges between 30 - 45 years. * all patients will have informed consent .exclusion criteria: * • surgery that conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.). * oral surgery (e.g., surgery for impaction of the third molar), as well as patients with concomitant systemic or neurological conditions.

Keywords: vr tmd maxillofacial surgery
a study to investigate the safety, tolerability and pharmacokinetics of inhaled chf6001

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a phase i randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

to assess the safety and tolerability of single and repeated ascending doses of chf 6001 in healthy volunteers and to investigate the pharmacokinetic (pk) profile of chf 6001 and its metabolites chf 5956 and chf 6095.

Eligibility criteria:
main inclusion * subject's written informed consent obtained prior to any study-related procedure * male and female caucasian healthy volunteers aged 18-55 years inclusive * vital signs:subjects aged 18-45: diastolic bp 40-90, systolic bp 90-140 subjects aged 45-55: diastolic bp 40-90, systolic bp 90-150 (as mean of three measures performed after at least 5 minutes of resting); checked at screening visit and day -1 * 12-lead digitised electrocardiogram (12-lead ecg) considered as normal (40≤heart rate≤110bpm,120 ms ≤ pr ≤ 210 ms, qrs ≤ 120 ms, qtcf ≤ 450 ms for males and ≤ 470ms for females) checked at screening visit and day -1 * lung function measurements within normal limits: fev1 \> 80% of predicted normal value (according to the global lung function initiative, ers task force lung function reference values (1,2) ) and fev1/fvc ratio \> 0.70 main exclusion: * pregnant or lactating women * clinically significant cardiac abnormalities * any clinically relevant abnormal laboratory values
arresting early childhood caries with a silver diamine fluoride gel

Conditions: Early Childhood Caries

Summary: the objective is to determine whether the efficacy of a 38% silver diamine fluoride (sdf) gel is non-inferior to a 38% sdf solution for arresting carious lesions in preschool children when applied at half-yearly intervals over a 30-month period.

aim: silver diamine fluoride (sdf) is typically available as a 38% aqueous solution, which is runny and difficult to apply. a 38% sdf gel has been introduced but it has not been tested clinically. the objective is to determine whether the efficacy of a 38% sdf gel is non-inferior to a 38% sdf solution for arresting carious lesions in preschool children. methods / design: this non-inferiority randomised clinical trial will recruit 630 3- to 4-year-old children to receive either sdf gel or sdf solution on their carious lesions every 6 months. the primary outcome is the proportion of active carious tooth surfaces that arrest at the 30-month follow-up. the same examiner will conduct all examinations at the kindergartens over 30 months. the examiner, the children, and the children's parents will be blinded to treatments. the parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification. significance: if the result is as anticipated, sdf gel will prolong contact of sdf with the carious lesion to promote remineralisation. as sdf gel is cost-effective, simple, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control.

Eligibility criteria:
inclusion criteria: * generally healthy, have at least one tooth with cavitated dentine carious lesion exclusion criteria: * uncooperative and difficult to manage, with severe forms of hypoplasia of fluorosis or other oral diseases, wearing orthodontic devices or under dental treatment, have major systemic diseases, or are on long-term medication

Keywords: silver diamine fluoride caries arrest gel children