Kornimate/medical-research-clean huggingface dataset:
thai-version five minute hearing test

Conditions: Hearing Loss

Summary: this study is aimed to test the sensitivity and specificity of thai-version five minutes hearing test against the audiometry to screen hearing problem in community.

study population phu wieng district, khon kaen province was chose to be a represent of rural community in thailand. 551 subjects were desired to cover 80% sensitivity of the original test, at 95% confidence level, 80% power, and 7% margin of error. regarding to 22.7% of the estimated prevalence of hearing loss and 10% drop out rate, then the total subjects need was 606 persons. subjects were divided to recruit from simple random villages, one from the municipal and the other from non-municipal area. all people in target villages whether having ear problem or not, who was older than 18 years old, could read or understand thai language, and wanted to participate, were persuaded. those who had aphasia, or severe mental disability, or other conditions that could not perform audiometry were excluded. study procedure after consenting to participate, subjects were interviewed with thai-fmht. then the subjects were undergone the audiometry in the soundproof booth performed by audiologists who were blinded the result of thai-fmht. pure tone threshold at 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 hz of both ears were recorded. tympanogram was done to confirm middle ear pathology. any pure tone air-conduction threshold greater than 25 db in one or two frequencies was considered as abnormal hearing. however, the severity of hearing loss was defined by pure tone average air-conduction threshold according to asha criteria. to compare with the original fmht, the pure tone average air-conduction threshold at 500, 1000, and 2000 hz was defined as speech pta (sf-pta), whereas, the pure tone average air-conduction threshold at 3000, 4000, 6000, 8000 hz was defined as high frequency pta (hf-pta). hearing disability was classified according to the hearing level of the better hearing ear. otolaryngologists did history taking. ear symptoms such as otalgia, itching, otorrhea, tinnitus, and hearing loss was asked before performing otoscopy and making a final diagnosis. the treatment, or medication if needed, and advice were complementary provided to subjects as post-trial benefits. statistical analysis descriptive analysis was used to present demographic data. the sensitivity, specificity, and roc were analyzed using stata software version 10.

Eligibility criteria:
inclusion criteria: * 18 years old or older exclusion criteria: * having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.

Keywords: hearing screening questionnaire hearing disability
impact of immunonutrition on the patients with cystic fibrosis

Conditions: Cystic Fibrosis; Malnutrition; Oxidative Stress

Summary: the primary objectives: to evaluate the effect of immunonutrition on the adult patient suffering from cystic fibrosis 1. safety of immunonutrition 2. the effect of immunonutrition on parameters of oxidative stress 3. the effect of immunonutrition on the inflammatory parameters 4. the effect of immunonutrition on nutrition status hypothesis the high oxidative stress is present in patients with cystic fibrosis. immunonutrition has been shown to positively modulate oxidative stress in the different clinical setting however it has not yet been evaluated inpatients with cystic fibrosis who frequently need some support by means of enteral nutrition. we anticipate that the substitution of routine enteral nutrition by immunonutrition will result in improving of oxidative stress parameters. ,

method crossover open study will take 16 weeks. the patients eligible for the study according to inclusion and exclusion criteria are going to be divided into 2 groups after signing the informed consent. in both groups their nutrition status, humoral and cellular immunity, respiratory system function and parameters of oxidative stress will be evaluated before entering the intervention. afterwards the patients are going to be divided into one group who will receive nutrition support using immunonutrition for the next 8 weeks while the second one will continue with their nutrition support using routine sipping support with no immunonutrition. according to our hypothesis oxidative stress parameters will improve in the group of patients on immunonutrition comparing to the other group. afterwards the patients will change their nutrition support for another 8 weeks. the patients who took immunonutrition in the first half of study will switch back to routine sipping support and contrary the patients who were in the first part of study on routine sipping will take immunonutrition. after the end of this period of study we expect the return of oxidative stress parameters to the baseline values in the group of patients who took immunonutrition in the first half of study but who were returned to routine nutrition support and contrary the improvement of oxidative stress parameters in the patients who started to take immunonutrition in the second half of study. the total energy support will be identical in both periods for each individual patient. after the first 8 weeks and after the completion of study the same examination are going to be evaluate as it was on the entrance to study. statistical analysis: means, sd, t-test, chi square test, mann whitney test, linear correlation and multilinear analysis

Eligibility criteria:
inclusion criteria: * cystic fibrosis * adult, elder 18 years * enteral nutrition at least for the last 12 monthes exclusion criteria: * patient waiting for lung transplant * patients with another life limiting disease-e.g. cancers

Keywords: cystic fibrosis, immunonutrition, oxidative stress
safety and efficacy of ziprasidone in adolescents with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of adolescents (ages 13-17) with schizophrenia

termination reason: on march 24, 2009, pfizer inc. stopped late stage geodon pediatric clinical trials in schizophrenia (a1281134 - placebo controlled; a1281135 - open label). as recommended by the dsmb, these studies were stopped due to lack of efficacy. no safety concerns were identified.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for schizophrenia: current symptoms were to be present for at least 7 days before screening. * at the screening and baseline visits, subjects must have had a brief psychiatric rating scale - anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization. * age 13 - 17 years exclusion criteria: * imminent risk of suicide or homicide, as judged by the site investigator * any history of serious or unstable medical illness, including risk for qt prolongation

Keywords: adolescent subjects with schizophrenia
a clinical trial comparing efficacy and safety of insulin degludec/liraglutide (ideglira) in subjects with type 2 diabetes mellitus using two different titration algorithms

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe, north america and the united states of america. the aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * male or female equal to or above 18 years of age * hba1c (glycosylated haemoglobin) 7.0 - 10.0% \[53 mmol/mol - 86 mmol/mol\] (both inclusive), confirmed by the central laboratory * stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening * body mass index (bmi) below or equal to 40 kg/m\^2 exclusion criteria: * current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids) * previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator) * treatment with glucagon-like peptide-1 (glp-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (dpp-4) inhibitors or sodium-glucose co-transporter 2 (sglt2) inhibitors within 90 days prior to the screening visit * impaired liver function, defined as alanine aminotransferase (alat) above or equal to 2.5 times upper normal range (unr) * impaired renal function defined as serum-creatinine above or equal to 133 micromol/l (above or equal to 1.5 mg/dl) for males and above or equal to 125 micromol/l (above or equal to 1.4 mg/dl) for females, or as defined according to local contraindications for metformin * screening calcitonin above or equal to 50 ng/l * proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2) * history of pancreatitis (acute or chronic)
phase ii ak study in organ transplant patients

Conditions: Actinic Keratoses; Carcinoma, Squamous Cell; Organ Transplant Recipients

Summary: the purpose of this study is to determine whether afamelanotide (cuv1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period. the number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.


Eligibility criteria:
inclusion criteria: * organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry * organ transplant patients who have had at least one biopsy-positive scc * aged 18 - 75 years * written informed consent to the performance of all study-specific procedures exclusion criteria: * allergy to afamelanotide (cuv1647) or the polymer contained in the implant * history of melanoma * current pigmentary disorders such as melasma * diagnosed with hiv/aids, or hepatitis b or c * current history of drug or alcohol abuse (in the last 12 months) * clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures * major medical or psychiatric illness * pregnancy as confirmed by positive serum beta-hcg pregnancy test prior to baseline or lactating mothers * females of child bearing potential not using adequate contraceptive measures * participation in a clinical trial for an investigational agent within 30 days prior to the screening visit * use of regular medications or any other factors that may affect skin pigmentation discontinuation criteria: * initiation of treatment with systemic retinoids * change of class of systemic immunosuppressant treatment

Keywords: actinic keratoses (ak) squamous cell carcinomas (scc) cuv1647 afamelanotide clinuvel photoprotection organ transplant
mood stabilizer-induced metabolic abnormalities in bipolar disorder

Conditions: Bipolar Disorder

Summary: the potential effects of microbiota in bipolar disorder (bd) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in bd patients.


Eligibility criteria:
inclusion criteria: * bipolar disorder outpatients (aged 18-65 years) who meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) diagnostic criteria and start to receive valproate (vpa) will be enrolled consecutively by trained psychiatrists. exclusion criteria: * exclude are patients who had dsm-v diagnosis for substance abuse within the past three months * had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study * presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc. * had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness * had a surgical condition or a major physical illness * were pregnant or breast-feeding * had any concomitant dsm-v axis i diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.
investigating the related factors and outcome of kinesiophobia and the effects of multidimensional interventions in cardiac surgery patients

Conditions: Cardiac Diseases Requiring Surgery

Summary: the primary objective of this two-year research project is to investigate the status of activity fear, its related factors, and prognosis in cardiac surgery patients in the first year. subsequently, the study aims to develop a comprehensive intervention strategy combining exercise with cognitive-behavioral approaches tailored for cardiac surgery patients and assess the effectiveness of this intervention on activity fear, prognosis, and quality of life in the second year.

the study uses a convenient sampling method, focusing on patients undergoing cardiac surgery in the cardiac surgery ward of the central medical center. the first-year research adopts a descriptive, correlational, and repeated-measures design, while the second-year research employs an experimental design. participants are randomly assigned to either the experimental or control group. the experimental group undergoes a 12-week multidimensional interventions, while the control group receives no intervention. data are collected through structured questionnaires. data collection occurs at discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks.

Eligibility criteria:
inclusion criteria: * patients received cardiac surgery. * aged 18 or above. * clear consciousness and able to communicate in mandarin or taiwanese. * willing and consent to participate after being informed of the study purpose and procedures. exclusion criteria: * cognitive impairment, * psychiatric disorders, and * long-term bedridden patients who rely on others for daily activities.

Keywords: kinesiophobia, cardiac surgery
mind-body medicine for patients with malignant hematological diseases

Conditions: Hematologic Neoplasms

Summary: this randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.


Eligibility criteria:
inclusion criteria: * patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation * physical and mental ability to attent 8 of 11 group units exclusion criteria: * chemotherapy, radiation, or rehabilitation programm during the study period * pregnancy * participation in other studies with behavioral interventions during the study period

Keywords: hematologic neoplasms supportive therapy fatigue mind-body medicine complementary and alternative medicine
askina calgitrol paste diabetic foot ulcers

Conditions: Diabetic Foot Ulcer (DFU)

Summary: the purpose of this study is to assess the efficacy of askina® calgitrol® paste in reducing local infection in subjects treated for mildly infected diabetic foot ulcers (dfu) with askina® calgitrol® paste.


Eligibility criteria:
inclusion criteria: * subject older than 18 years old * provision of written consent by the subject themselves * subjects with a texas stage i-b wound below the malleolus: superficial and infected (wagner-armstrong classification system). * subjects with a mildly infected wound according to the infectious diseases society of america (idsa). * size of wound \>2 cm2. * absence of ischaemia of the lower limb as assessed by : 1. transcutaneous oxygen pressure (tcpo2) \> 30 mmhg. 2. toe pressure \> 50 mmhg. 3. ankle pressure \> 70 mmhg. * capable of following study instructions. * compliant with treatment and in particular with off-loading regime. * stable management of their diabetes as defined by an hba1c (%) of 12% exclusion criteria: * subjects who are \<18 years old. * subjects with a documented sensitivity to alginates or silver. * subjects taking a medication or using a device comprising silver. * subjects already taking antibiotics before enrolment * subjects undergoing dialysis. * subjects using therapy known to be immune-compromising such as systemic anti-neoplastic drugs and/or systemic cortico-steriods. * pregnancy * breast-feeding * currently participating in another clinical trial, or who have participated in another clinical trial in the last 6 weeks or who have previously taken part in this study
characterization and analysis of evoked cortical responses in participants with medication-intractable epilepsy

Conditions: Intractable Epilepsy

Summary: the goal of this project is to study how the brain reacts to a small electrical signal. researchers will be using a novel combination of recording electrodes. the researchers will measure the brain response from these electrodes.


Eligibility criteria:
inclusion criteria: * patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus * can provide informed consent for the study and willing to participate exclusion criteria: * presence of a permanent electronic implant * any chronic medical conditions that prevent safe placement of electrodes
non-interventional, prospective study to determine prevalence of egfr mutations in non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (ia to iiib on the basis of pathologic criteria) non-squamous nsclc up to 6 weeks prior to enrolment into the study. the main objective of this study is to determine the prevalence of egfrm in patients with surgically resected early-stage (ia to iiib) non-squamous nsclc as there are limited data on its prevalence in this patient population.

this prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (ia to iiib on the basis of pathologic criteria) non-squamous nsclc up to 6 weeks prior to enrolment into the study. eligible patients should have availability of formalin-fixed paraffin-embedded (ffpe) specimen(s) to be primarily tested for egfrm at validated local laboratories or a central laboratory. the informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. the data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. if pd-l1 testing is conducted as part of routine clinical care, the available results will be recorded. patients will be followed prospectively and follow-up will be considered as complete once egfrm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.

Eligibility criteria:
inclusion criteria: * adult male or female patients ≥18 years old or 'adults' according to age of majority as defined by the local regulations * patient or next of kin/legal representative is willing and able to provide informed consent according to the local regulations, where applicable * patients with stage ia to iiib (on the basis of pathologic criteria) nsclc with adenocarcinoma, or mixed histology with an adenocarcinoma component who have undergone surgical resection of the tumour during the preceding 6 weeks * availability of ffpe tissue specimen suitable for egfrm testing (either the primary diagnostic sample or the surgically resected tumour specimen) * availability of medical records at the participating site detailing the initial diagnosis, staging, and surgical management of nsclc exclusion criteria: patients who fulfil any of the following exclusion criteria will not be eligible for the study: 1. histology of the tumour is considered not to be of primary lung in origin 2. histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma differentiation -
efficacy and safety of vildagliptin in combination with metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. the purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.


Eligibility criteria:
inclusion criteria: * blood glucose criteria must be met * on a stable dose of metformin as defined by the protocol * body mass index (bmi) in the range 22-45 exclusion criteria: * type 1 diabetes * pregnancy or lactation * evidence of serious diabetic complications * evidence of serious cardiovascular complications * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
use of a family navigator in families with children newly diagnosed with autism spectrum disorder

Conditions: Autistic Disorder

Summary: the purpose of this study is to see whether or not family navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an autism spectrum disorder.


Eligibility criteria:
inclusion criteria: * child with a new confirmed diagnosis of autism spectrum disorder * child is under 8 years of age * parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver * primary caregiver speaks english, spanish, haitian creole, somali, vietnamese, portuguese or chinese exclusion criteria: * parent or legal guardian has psychosis * parent or legal guardian endorses suicidal ideation * parent or legal guardian actively using illicit drugs * parent or legal guardian expected to leave area within 6 months

Keywords: family navigator autistic disorder early intervention developmental disabilities child development disorders