Kornimate/medical-research-clean huggingface dataset:
the relationship between pain perception, severity of temporomandibular joint dysfunction, and spinal health in geriatric individuals

Conditions: Geriatric Individuals; Pain; Discomfort; Spine; Temporomandibular Disorder

Summary: it is aimed to examine the relationship between pain perception, temporomandibular joint disorder severity and spine health in elderly individuals.

the research sample will consist of elderly individuals who reside in tokat and kırıkkale, are over 65 years old, have good cognitive status, and volunteer to participate in the study. according to the g\*power analysis, if the sample size is α= 0.05, β= 0.80, acceptable correlation coefficient r= 0.70, and negligible correlation coefficient r= 0.20, 16 individuals are sufficient to measure the relationship between two parameters. since the relationship between four parameters will be evaluated, 64 individuals are required. data for the study will be collected face to face by researchers using the centrality of pain scale, discomfort intolerance scale, spine functional index, and fonseca anamnestic index, which can be filled in by individuals themselves. statistical package for social sciences (spss), version 22.0 computer package program for windows, will be used for statistical analysis. statistical data will be expressed as mean ± standard deviation (x±sd), median, or percentage (%). one sample kolmogorov smirnov test will be performed to show the parametric or nonparametric distribution of the data. when parametric test assumptions are met, the relationship between parameters is determined by spearman correlation test; when parametric test assumptions are not met, the relationship between the parameters will be examined with the pearson correlation test. statistical significance value will be accepted as p\<0.05.

Eligibility criteria:
inclusion criteria: * to be volunteer exclusion criteria: * having any neurological, psychiatric or cognitive disorder

Keywords: geriatric individuals pain discomfort spine temporomandibular disorder
a study to investigate the effect of hmb on skeletal muscle wasting in early critical illness

Conditions: Critical Illness

Summary: this study aims to investigate the effect of beta-hydroxy-beta-methylbutyrate (hmb) on skeletal muscle wasting, physical function, strength and quality of life in survivors of critical illness. in addition, protein turnover, muscle biology and muscle histology will be investigated.

this is a double blind, placebo controlled, randomised controlled trial with the primary objective of investigating the effect of hmb on skeletal muscle wasting in early critical illness. secondary objectives include determining the effect of hmb on skeletal muscle quality, strength, function and quality of life in survivors of critical illness. in addition, the effect of hmb on muscle protein turnover, muscle protein signalling, muscle fibre size and protein:dna ratio will be investigated in a sub-group of participants. eligible participants will be randomised to receive either 3 g/day hmb or 3 g/day placebo within 24 hours of admission to the intensive care unit (icu). this will be continued until hospital discharge or 28-days, whichever comes first.

Eligibility criteria:
inclusion criteria: (i) ≥18 years old (ii) due to receive enteral nutrition via a nasogastric or naso-jejunal tube as part of routine care (iii) receiving mechanical ventilation and likely to continue this for more than 48 hours (iv) likely to remain on the icu for \>7 days (v) likely to survive intensive care admission. (vi) admitted to recruiting icu \<24 hours from hospital admission and referring icu ≥7 days from hospital admission (vii) agreement obtained from legal representative (viii) able to comply with protocol and study procedures (ix) no known allergy to imp or any of its excipients participants in other trials can be recruited where protocols are not deemed likely to interfere with endpoints of either study and agreement has been obtained from the respective chief investigators. since participants in the trial will be abstaining by virtue of their illness, contraception is not required as an eligibility requirement. exclusion criteria: (i) pregnancy or breast feeding (ii) active disseminated malignancy (diagnosed) (iii) bilateral lower limb amputees (iv) non-ambulant or acute unilateral lower limb amputees (v) patients with a primary neuromyopathy (vi) patients entered into trials of interventions which would affect muscle mass (vii) patients assessed as requiring sole parenteral nutrition (viii) admission to icu within the previous 3 months (ix) any reason excluding ultrasound measurement being performed (x) insufficient understanding of the trial by the legal representative (xi) intolerance to lactose and/or milk protein allergy

Keywords: critical illness hmb nutrition muscle wasting recovery
immunogenicity of the booster dose of two menc vaccines

Conditions: Meningococcal Infection

Summary: the purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal c conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.

children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men c vaccine or three doses of the crm197 conjugated polysaccharide men c vaccine before 7 months of age, are randomized to receive any of the two vaccines. serum antibody activity against meningococcus c will be measured inmediately before and 4 weeks after the booster dose. children will also be vaccinated with a combined vaccine containing dtap+ipv+hib.

Eligibility criteria:
inclusion criteria: * healthy toddlers of both sexes * toddlers of 14 to 19 months of age (including the day that the toddler is 14 and the day before he is 19 months of age) * children previously vaccinated with two doses of polysaccharide meningococcal c vaccine conjugated to tetanus toxoid or three doses of polysaccharide meningococcal c conjugated to crm197 before 7 month of age. * informed consent signed by one or both parents who are adequately informed about the study. exclusion criteria: * toddlers with severe diseases or axilar temperature ≥ 38,0ºc at inclusion time * toddlers with severe chronic diseases * toddlers who have received any other vaccine within the last month or with a programmed vaccination within the 28 subsequent days after the administration of the vaccine of study. * toddlers with clinical or bacteriological diagnosis of previous meningococcal disease. * toddlers with hypersensitivity to any of the components of the vaccines to study or antibiotics used during the manufacturing process that could be present as non- detectable traces (streptomycin, neomycin, polymyxin b). * toddlers with personal history of convulsions. * toddlers with known bleeding disorder no controlled * toddlers with known congenital or acquired immunodeficiency * toddlers who are receiving or have been received any treatment that could change the immune response (administration of intravenous immunoglobulin, systemic corticosteroids or haemoderivates) within the 3 previous months. * a toddler that under investigator opinion is probable to be lost during the follow-up * a toddler that is currently included or is planned to be included in any other clinical trial. * a toddler that under investigator opinion must not be included in the study due to other medical or social reasons.

Keywords: meningococcal vaccine immunization, secondary vaccines conjugated meningococcal disease
a single-component cbt for gad

Conditions: Generalized Anxiety Disorder

Summary: generalized anxiety disorder (gad) is a chronic condition that is characterized by excessive and uncontrollable worry and anxiety. in canada, 3 to 4% of the population suffer from gad at any point in time. these individuals have a lowered quality of life and are at risk for many medical conditions such as coronary heart disease and cancer. research suggests that both pharmacological and psychological approaches are effective for treating gad in the short-term; however, psychological treatments appear to offer the greatest long-term benefits. there exist a number of effective psychological treatments for gad, most of which fall into the category of cognitive-behavioural therapy or cbt. in the 1990s, a group of canadian investigators developed a cbt protocol for gad that included four components. data from five clinical trials suggest that one of the four components is particularly important for treatment success: experiencing uncertainty rather than avoiding it in everyday life. stated differently, learning to tolerate and deal with uncertainty appears to be the key to decreasing worry and anxiety. given this finding, the investigators have developed a new treatment that exclusively targets intolerance of uncertainty: behavioural experiments for intolerance of uncertainty or be-iu. the goal of the current proposal is to test the efficacy of be-iu by comparing it to a waiting list (wl) control condition. a total of 50 participants with a primary diagnosis of gad will be randomly assigned to either be-iu or wl and will be assessed at 5 time points ranging from pre-treatment to 12-month follow-up. the conditions will be compared in terms of treatment efficacy and mechanisms. the investigators will also examine the predictors of change during the 12-months following treatment. the proposed study will produce data on the efficacy and mechanisms of a treatment for gad that is less costly, less complex and easier to disseminate than treatments that are currently available.


Eligibility criteria:
inclusion criteria: 1) at least 18 years of age; 2) principal diagnosis of gad; 3) no change in medication type or dose in 4 to 12 weeks before study entry (4 weeks for benzodiazepines, 12 weeks for antidepressants and hypnotics); 4) willingness to keep medication status stable while participating in the study; 5) no use of herbal products known to have cns effects in the 2 weeks before study entry; 6) no evidence of suicidal intent (based on clinical judgement); 7) no evidence of current substance abuse, current or past schizophrenia, bipolar disorder or organic mental disorder; 8) no current participation in other trials; 9) no concurrent psychotherapy during treatment phase of trial; 10) no evidence of anxiety symptoms due to a general medical condition based on clinical judgement (e.g., clinical hyperthyroidism, hypoglycaemia, anaemia). exclusion criteria: -

Keywords: cognitive-behavioural therapy
effect of colloid versus crystalloid on coagulation

Conditions: Bloodloss

Summary: in order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.


Eligibility criteria:
inclusion criteria: * patient more than 18 years old * indication for elective post-renal operation including cystectomy * patient without anticoagulative, acetylsalicylic acid or nsaid treatment for the last 5 days. exclusion criteria: * intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases * pregnant or nursing * allergic * disturbance in electrolytes * patient under committee * patient joining another trial interfering the actual trial.
physiological phenotyping of respiratory outcomes in infants born premature

Conditions: Premature Lungs

Summary: the purpose of this study is to examine if infants are more likely to suffer from respiratory complications during their first year of life due to being born premature.

the overall objective of this study is to determine if infant respiratory morbidities after preterm birth are highly variable due to differential impairment of airway, parenchymal and vascular development that can be characterized as distinct physiologic phenotypes. if the nature and severity of these specific impairments of lung function are strongly associated with increased respiratory morbidities during infancy and that proteomic biomarkers can enhance the physiologic characterization of phenotype and prediction of late respiratory outcomes.

Eligibility criteria:
inclusion criteria: * infants born to mothers who are between the gestational ages of 24+0 and 36+6 weeks. exclusion criteria: * cardiopulmonary defects * chromosomal defects * structural abnormalities of the upper airway, chest wall, or lungs * neurological/neuromuscular disorders * infant not considered viable * family unlikely to be available for long term follow up * mothers under the age of 18. * non english speaking
rate of change of hba1c (dx/dt) may predict progression to type 2 dm

Conditions: Diabetes Mellitus Type 2

Summary: the investigators hypothesize that the hba1c shows a rising trend in pre-diabetics and normal population with risk factors of developing type 2 dm. there is no known diabetes model for predicting incident diabetes in an individual which takes into account the rate of change of hba1c (dx/dt). in such cases, the rate of change of hba1c may give the physicians lead time needed to implement the diabetes prevention program measures.


Eligibility criteria:
inclusion criteria: * no self-reported history of diabetes or pre-diabetes defined as per ada criteria * age greater than 18 years * scheduled to receive hba1c in participating clinic * able and willing to give legally effective consent * able and willing to participate in patient questionnaires(attached) exclusion criteria: * previously or currently taking medications for lowering glucose (i.e., exenatide, pramlintide, metformin, rosiglitazone, pioglitazone, or future diabetes drugs) based on self-report and/or prescreening. patients on drugs causing hyperglycemia like oral steroids will be excluded. * baseline hba1c level above 5.7 * severe anemia (defined as hb less than 8gm/dl) * patients with hemoglobinopathies * pregnancy * polycystic ovarian disease
a radiolabeled mass balance study of [14c]-ertugliflozin (pf04971729, mk-8835) in healthy male participants (mk-8835-038)

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this is single dose study of radiolabeled \[14c\]-ertugliflozin (pf04971729, mk-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.


Eligibility criteria:
inclusion criteria: * healthy male participants with body mass index of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs) exclusion criteria: * female participants. participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening

Keywords: absorption distribution metabolism and excretion mass balance metabolic profile radiolabel study
misoprostol with or without letrozole in treatment of missed miscarriage

Conditions: Missed Abortion

Summary: aim of study compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. hypothesis: letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. research question: will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

aim of the work compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. hypothesis: letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. research question: will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester? primary outcome: complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol. secondary outcome: • curettage (surgical evacuation of the products of conception) * incomplete abortion (retained products of conception). * considerable bleeding that necessitates immediate evacuation.

Eligibility criteria:
inclusion criteria: * woman age more than 18 years old (age of legal consent). * bmi ranges between 25 kg/m2 and 35 kg/m2. * gestational age of 63 days' gestation (or less). * missed abortion. * hemoglobin leve exclusion criteria: * woman age less than 18 years old. * bmi less than 25 kg/m2 or more than 35 kg/m2. * gestational age more than 63 days' gestation. * molar pregnancy. * hemoglobin level less than 10 gm/dl. * fibroid uterus. * uterus with congenital anomalies. * previous attempts for induction of abortion in the current pregnancy. * coagulation defect i.e. coagulopathy. * contraindication for induction of abortion e.g. heart failure. * allergy to misoprostol or letrozole.
safety and efficacy of sotagliflozin (lx4211) in patients with inadequately controlled type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this phase 2 study was intended to assess the pharmacodynamics (pd), pharmacokinetics (pk), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (t1dm).


Eligibility criteria:
inclusion criteria: * adults \>=18 to \<=55 years of age * confirmed diagnosis of t1dm, diagnosed prior to age 40 years, and for at least 6 months prior to screening * willing to refrain from using carbohydrate counting to adjust insulin during the study * willing and able to wear and operate a continuous glucose monitor * willing and able to self-assess blood glucose * willing and able to provide written informed consent. exclusion criteria: * history of type 2 diabetes mellitus or diabetes resulting from acromegaly, cushing's disease, chronic pancreatitis, or pancreatectomy * two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to screening * use of premixed insulin * history of diabetic ketoacidosis within 1 year of screening * presence of active hepatic disease or clinically significant abnormal liver function tests * history of chronic pancreatitis * participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure * history of clinically significant cardiac arrhythmias within 1 year prior to screening * participants with congestive heart failure * participants with uncontrolled stage iii hypertension * history of human immunodeficiency virus (hiv) or hepatitis c * history of illicit drug or alcohol abuse within 12 months prior to screening * use of any investigational agent or device within 30 days prior to screening or any therapeutic protein or antibody within 90 days prior to screening * use of medication or herbal supplements taken for weight loss within 2 weeks of screening * chronic use of any antidiabetic therapy other than insulin within 2 months prior to screening * use of systemic or inhaled corticosteroids within 2 weeks prior to screening * participants who underwent major surgery within 6 months prior to screening * inability or difficulty swallowing whole tablets or capsules * women who were pregnant or breastfeeding.
a study of mood and stress after spinal cord injury

Conditions: Spinal Cord Injury; Depression

Summary: this is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.

the objective of this study is to examine the degree to which vulnerability factors are mediated by stress to increase risk for depression after sci in a sample of adults who sustained their injuries after the age of 18 years. participants will complete a written survey (about pain, daily activities, social support and life experiences) and a telephone interview that will provide information about these factors.

Eligibility criteria:
inclusion criteria: * have a spinal cord injury * were age 16 years or older when injured * sudden onset of symptoms exclusion criteria: * under 19 years old * less than 1 year post-injury * had a non-traumatic injury

Keywords: depression quality of life disability
effects of memantine on magnetic resonance (mr) spectroscopy in subjects at risk for alzheimer's disease

Conditions: Alzheimer's Disease

Summary: recent data show that marked cell damage precedes the clinical manifestation of alzheimer's disease (ad). hence, targeting populations at risk with pharmacological interventions is a possible strategy to lessen the burden of the disease. cognitively normal individuals with subjective memory complaints (smc) manifest biological characteristics consistent with early ad and are at risk for future cognitive decline. family history of ad also constitutes a risk. in a previous study the investigators showed that memantine slows down the accumulation of phosphorylated tau in normal smc subjects. using a multivoxel high field mr spectroscopy (mrs) technique, the investigators also demonstrated that memantine decreased hippocampal glutamate. both these findings may be consistent with the drug's anti-excitotoxic activity. in this new project the investigators propose to treat a sample of 12 presymptomatic individuals at risk (smc and family history of ad) with memantine. this will be a double blind, placebo controlled study with a control group (12 non-treated subjects). the investigators will determine whether the effects of memantine as assessed by cognitive performance and mrs are present after 4 months of treatment and persist 2 months after discontinuation. mrs will be used to evaluate the effect of memantine on levels of the neurotransmitter glutamate and neuronal viability marker n-acetylaspartate (naa) in the hippocampus. the investigators will test the following hypotheses: 1. in subjects with smc, memantine has modifying effects on brain biochemistry as reflected in mrs reductions in glutamate (reduced excitotoxicity) and increases in naa (neuronal integrity). 2. the effects of the drug persist (as a marker of sustained neuroprotection) and can be measured 2 months after discontinuation of the treatment.


Eligibility criteria:
inclusion criteria: * presence of subjective memory complaints without objective evidence of impaired cognition * family history of alzheimer's disease exclusion criteria: * major depression * parkinson's disease * stroke * seizures * uncontrolled diabetes or hypertension * current benzodiazepine use * substance abuse * contraindication for mri * contraindications for memantine

Keywords: subjective memory complaints cognitively healthy family history ad
urban walking circuits

Conditions: Severe Chronic Obstructive Pulmonary Disease

Summary: the aim of this study was to assess the effectiveness of the implementation of walking urban circuits in increasing the level of physical activity and exercise capacity in severe chronic obstructive pulmonary disease (copd) patients after being enrolled in a pulmonary rehabilitation program.


Eligibility criteria:
inclusion criteria: * severe copd (post-bronchodilator forced expiratory volume in one second (fev1)/ forced vital capacity (fvc) \<0.7 and fev1 \<50%) and stable disease defined as no exacerbation, hospital admission or change in treatment in the previous three months. exclusion criteria: * the exclusion criteria were: other significant respiratory disease (bronchiectasis, lung fibrosis, asthma, etc.), active smoking, severe cardiovascular, neurological, musculoskeletal and/or metabolic pathology that could interfere with the results, alcoholism (\>80g/day) or severe malnutrition (bmi\<19kg/m2).

Keywords: exercise, physical activity, rehabilitation, copd.