Kornimate/medical-research-clean huggingface dataset:
early age-related hearing loss investigation pilot study

Conditions: Hearing Loss

Summary: the purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger r01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years. secondary purposes include: to determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.

this is an observational pre-post intervention feasibility study. in addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. thus, the purpose of this study is twofold: first, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention. there are no experimental or investigational devices or agents used in this study. we are providing best-practices standard of care hearing intervention including hearing aids. we are additionally tracking activity using the actigraph wgt3x-bt, an fda-approved class ii medical device that tracks continuous, high resolution physical activity and sleep/wake information. participation involves a minimum of 6 in-office study visits. intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session. significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.

Eligibility criteria:
inclusion criteria: * adults aged 55 to 75 years old with little or no experience with hearing aids * english or spanish speakers exclusion criteria: * unable to complete written questionnaires on a tablet without assistance * refer for cognitive screening score based on criteria using the mini mental state examination
force sensing resistor for obstructive sleep apnea patients after tongue base reduction surgery

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea syndrome (osa) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. these traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing \[a low respiratory arousal threshold\], ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control \[high loop gain\]) components. oropharyngeal training reduces the snoring times, apnea-hypopnea index (ahi) and daytime sleepiness. there is lack of good evaluating tools to distinguish different phenotypes of osa and the efficacy of combined therapy. the purposes of our study are (1) to evaluate osa patient by using polysomonogrphy (psg), force sensing resistor (frs), drug induce sleep endoscopy (dise) and ct and muscle strength testing, (2) to know the exercise times by using fsr and (3) the efficacy of exercise in different groups.

subjects who are newly diagnosed with mild to severe osa (ahi \>5/h), and the physician will explain the treatment programs to every subject. by the result of muscle strength testing, the subjects will be classified as low muscle strength and normal groups. the myofunctional therapy program will begin at 6 week after surgery, and subjects will undergo 12 weeks of the home-based oropharyngeal myofunctional therapeutic training. during the training intervention period, subjects will be interviewed one time per week for adjusting the treatment intensity. expected results：the hypothesis of this study is the efficacy of exercise would be less in the low muscle strength osa patient than normal.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to severe osa in the past year * agree to receive transoral robotic surgery (tors) * age between 20-65 years old. exclusion criteria: * body mass index ≧ 32 * drug abuse within one year * pregnant * severe obstructive or restrictive lung disease * a history of malignancy or infection of the head and neck region and laryngeal trauma * craniofacial malformation * stroke * neuromuscular disease * heart failure * coronary artery disease * ongoing or uncontrolled chronic diseases * combine central or mixed types sleep apnea syndrome * other non-breath related sleep disorder.
iop changes associated with sics and phako

Conditions: Cataract; Glaucoma

Summary: prospective randomized trial in patients requiring cataract surgery in which iop, angle anatomy and other demographic and clinical data are compared. subjects randomized to both msics and phakoemulsification

prospective, randomized, double masked, parallel assignment clincal trial. five hundred eyes of 500 participants between 40 - 70 years with normal iop, gonioscopically open angles and age related cataract. eyes underwent phacoemulsification or msics following a 1:1 randomization and allocation code. best corrected vision (bcva), iop, comprehensive slit lamp evaluation and anterior segment optical coherence tomography (asoct) were performed at baseline and at 1, 3 and 6 months follow up.

Eligibility criteria:
inclusion criteria:age over 40 requiring cataract surgery - exclusion criteria: inability to follow up, lens not suitable for phacoemulsification, prior intraocular surgery, glaucoma -
efficacy, safety, and tolerability of plovamer acetate (pathway 1)

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is a phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator copaxone in subjects with relapsing remitting multiple sclerosis (rrms). the trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.


Eligibility criteria:
inclusion criteria: * male or female, between the ages of 18 and 60 years * subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject) * subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria) * other protocol defined inclusion criteria could apply exclusion criteria: * any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing * allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri * any requirement for continuous systemic glucocorticoid administration during the trial period. (note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed) * contraindication to copaxone use * other protocol defined exclusion criteria could apply

Keywords: multiple sclerosis relapsing remitting plovamer acetate copaxone
prediction of chronic pain by the pain monitor

Conditions: Surgery

Summary: the skin conductance algesimeter (pain monitor™, med-storm innovation as, no-0264 oslo, norway)) reflects the sympathetic nervous system by the measurement of the skin conductance of the palm of the hand. sca detects nociceptive pain fast and continuously, specific to the individual, with higher sensitivity and specificity than other available objective methods. the skin conductance response to a calibrated noxious stimulus varies among patients. it defines two types of people depending on its magnitude. the investigators assume that the importance of skin conductance response to a noxious stimulus predicts the occurrence of chronic pain in patients operated by thoracotomy.


Eligibility criteria:
inclusion criteria: * adult patients of both sexes * planned pulmonary resection for cancer performed by a posterolateral thoracotomy * thoracic epidural analgesia exclusion criteria: * pregnancy, * morbid obesity, * insulin-dependent diabetes with dysautonomia, * inability to proceed with anesthesia using the bis signal, * known allergy to remifentanil, propofol, atracurium or to levobupivacaine, * contra-indication to nefopam * contra-indication to ketoprofen
2014tp001 - assessing the biology of the injured lung - version 1

Conditions: Respiratory Diseases

Summary: respiratory diseases are very common and are the third leading cause of death in england. as such, there is strong interest in understanding how respiratory disease occurs. this study intends to understand the changes that occur within diseased/injured lungs obtained from humans. the end goal of this will be to create new drugs to help treat these disorders. diseased lungs will be obtained from patients receiving a lung transplant. lungs will either be placed onto a heart-lung machine, or surgically cut in order to create a model of the lung that can be used experimentally in the laboratory. using a heart-lung machine, lungs can be maintained outside of the human body for a maximum of 12 hours, allowing the direct assessment of the organ. using this procedure, we aim to understand the processes that occur within a disease, as well as during repair. using the model of the lung, we will look at how the body's immune system interacts within a diseased lung.


Eligibility criteria:
inclusion criteria: * patients must be able to provide informed consent * patients must be aged between 18-80 years of age exclusion criteria: -patients under 16 or over 70 years of age
study of male osteoporosis and aging

Conditions: Osteoporosis

Summary: the aim of this study is to identify potential risk factors for fragility fractures in men.

osteoporosis is a disease characterized by decreased bone mass and pathological changes in the microarchitecture of the bones. the clinical significance of osteoporosis is the association with fragility fractures and, consequently, increases in both morbidity and mortality. in men, genetical and life-style factors are known to affect the risk of fractures, however, data relating these factors with measures of bone mineral density and fracture risk are limited. 30.000 men aged 60-70 were randomly selected from the central office of civil registration in denmark. each receive a questionnaire addressing demographics, potential risk factors of osteoporosis, past medical history and medication by mail. in case of consent, the participants will complete a full medical examination including dxa and sampling of dna if they have a fragility fracture. at the same time, 2 participants from the study population will be selected as control. the study period is 10 years.

Eligibility criteria:
inclusion criteria: * men aged 60-70 being able to consent in writing

Keywords: osteoporosis male fracture risk genetical epidemiology
lateral arm free flap for reconstruction of the oral cavity and head and neck soft tissue defects.

Conditions: Oral Cancer

Summary: the excision of oral cancers causes extensive impairment of the oral cavity soft tissue. complete excision of the tumors is vital, and the reconstruction of the resected area influences not only the postoperative recovery period of patients but also physiological functions such as swallowing, phonation function ,daily activities and psychosocial impact. oral and maxillofacial surgeons are faced with the task of reconstructing the affected area to reduce these problems as much as possible. in 1982, song introduced the lateral arm flap (laf). since this time, its used in surgical repairs of oral defects, but the specific subject of publications generally restricted to a small number of cases. laf is a thin and pliable flap with consistent anatomy and a high success rate. it is also claimed that there is no risk of vascular compromise to the arm

reconstruction of oral , head and neck defects with lateral arm free flap

Eligibility criteria:
inclusion criteria: 1. all patients post glossectomy. 2. patients post maxillectomy with malignant maxillary swelling with no distant metastases. 3. all patients which defect after surgery for head and neck neoplasia. exclusion criteria: * 1. small defect post excision can be closed directly 2. medically unfit patients
investigating serotonin signalling in ibd patients

Conditions: Inflammatory Bowel Disease

Summary: alterations in normal serotonin (5-hydroxytryptamine;5-ht) signaling have been reported in ulcerative colitis (uc) and crohn's disease (cd). studies report an increase in enterochromaffin (ec) cell, main source of 5-ht in the gut, numbers in cd and uc patients. up-regulated expression of mucosal tryptophan hydroxylase (tph)-1, catalytic enzyme in 5-ht production, messenger rna (mrna) have been found in cd patients in remission who are suffering the irritable bowel syndrome (ibs)-like symptoms. alterations in normal 5-ht signaling has also been reported in animal models of inflammatory bowel disease (ibd). thus, the aim of the proposed research project will be to study the alterations in 5-ht signalling accompanying gi inflammatory conditions, such as ibd.

the gut produces approximately 95% of serotonin (5-hydroxytryptamine; 5-ht) found in the human body; where, it is a very important mucosal signaling molecule participating in gut motility, sensation, and secretion.the vast majority of the gut-derived 5-ht is produced by specialized epithelial cells of the gi tract, called enterochromaffin (ec) cells. ec cells produce 5-ht from dietary tryptophan, this process involves the rate limiting enzyme tryptophan hydroxylase (tph) 1, once produced this 5-ht can be released into the gut lumen, surrounding tissue and can enter the blood circulation.5-ht mediates many gastrointestinal functions, including secretion and peristalsis, by acting on a diverse range of 5-ht receptors. five of the seven known receptor families of 5-ht (5-ht1, 5-ht2, 5-ht3, 5-ht4 and 5-ht7) are expressed in the gut. 5-ht has been evaluated in ibd and in animal models of colitis. an increase in numbers of ec cells expressing 5-ht is observed in cd and uc patients and consumption of selective 5-ht reuptake inhibitors is associated with microscopic colitis. in the present study, we plan to investigate the key elements of mucosal 5-ht signaling in cd patients for a better understanding of the role of 5-ht in pathogenesis of ibd.

Eligibility criteria:
inclusion criteria: * patient groups: disease diagnosis (cd or uc),duration of disease, previous/type of treatments, duration of treatment and disease prognosis. * healthy controls: no diagnosis of cd or uc and no diagnosis of ibs. exclusion criteria: * patient groups: drugs that directly affect components of 5-ht signaling, any other disease or condition that may interfere with study assessments as judged by the investigator. * healthy controls:chronic use of any anti-inflammatory drugs, drugs that directly affect components of 5-ht signalling and any other disease or condition that may interfere with study assessments as judged by the investigator.

Keywords: ibd, cd, uc, serotonin, 5-ht
a local experiential study with sitagliptin (an antihyperglycemic drug) in 30 patients with type 2 diabetes mellitus (0431-178)

Conditions: Type 2 Diabetes

Summary: this study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (t2dm) who failed to achieve glycemic control on metformin monotherapy.


Eligibility criteria:
inclusion criteria: * participants with t2dm failing metformin monotherapy * between the ages of 18 and 79 exclusion criteria: * participants has a history of type 1 diabetes mellitus or ketoacidosis
development of pharmacogenomic method to predict antidepressant responsiveness

Conditions: Depression; Antidepressant Drug Adverse Reaction

Summary: the purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

the difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) the time lag is existed until the patients respond to antidepressant and show the treatment effects. if it is predicted the response of antidepressant in advance, it would be overcome such problems. drug response generally is known to be related to the individual genetic information and the environmental factors. we are going to investigation about antidepressant response using these approaches.

Eligibility criteria:
inclusion criteria: 1. 25 \< age \<85 2. major depressed patients satisfied with the diagnosis criteria depression of dsm-iv 3. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians exclusion criteria: 1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks 2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant axis i psychiatric disorder.

Keywords: depression pharmacogenomics antidepressant response biological markers clinical variables
ketamine improves post-thoracotomy analgesia

Conditions: Post Operative Pain

Summary: thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (midcab) surgery, may be associated with debilitating pain. ketamine was shown to enhance opioid antinociception and prevent opioid resistance. we hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.

we planned a prospective, randomomized, double blind study of 2 pain management protocols in consecutive patients undergoing thoracotomy for midcab or lung tumor resection over a 6 month period. after patients emerged from a standardized general anesthetic and when objectively awake and complaining of pain \>5/10 on a visual analogue pain scale, they were connected to an intravenous patient controlled analgesia regimen. the regimen was assigned randomly to be either morphine alone (1.5 mg per dose, lockout interval of 7 minutes) or morphine plus ketamine (1.0 mg morphine plus 5 mg ketamine per dose, same lockout interval). rescue diclofenac was available to both groups. follow-up lasted 4 hours. we planned to monitor and compare pain scores, wakefulness scores, hemodynamic and respiratory parameters as well as total morphine consumption and incidence of side effects and complications. all monitoring and recording was done by blinded nurses and intensive care physicians.

Eligibility criteria:
inclusion criteria: * consecutive patients scheduled for elective minimally invasive direct coronary artery bypass (midcab) or for lung resection via anterolateral thoracotomy during a 6-month period (sep 2001-march 2002) exclusion criteria: exclusion criteria were: * american society of anesthesiologists (asa) physical class ≥3, emergency operations, * q-wave myocardial infarct occurring during the previous 3 weeks, or poor left ventricular function (e.g., ejection fraction \[ef\] \<30% by echocardiography or angiography). other exclusion criteria were: * a body mass index \>35 kg/m2, * past or current neuropathy or psychological disturbances, * the use of centrally active drugs, * chronic liver or renal failure requiring dialysis, * a fev1/fvc \<70%, * allergy to ketamine, morphine or non steroidal anti inflammatory drugs (nsaids), * clotting abnormalities, * a platelets count \<70000/mm3, * a white blood count \ 14000/mm3, * uncontrolled diabetes mellitus or fasting blood glucose \>250 g/dl, * evidence of sepsis or infection up to one week prior to randomization.

Keywords: thoracotomy minimally invasive direct coronary artery bypass ketamine pain
time to efficacy and onset of action of linezolid

Conditions: Gram-Positive Bacterial Infections; Skin and Connective Tissue Diseases

Summary: to assess the onset of action of linezolid


Eligibility criteria:
inclusion criteria: * suspected grampositive infection * fever \> 38 c exclusion criteria: * infections to be treated successfully by surgical procedures
effects of ly450139, on the progression of alzheimer's disease as compared with placebo

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) is a fatal degenerative disease of the brain for which there is no cure. ad causes brain cells to die. ad is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. at autopsy, ad patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of ad. inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. semagacestat (ly450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. this study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. the buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. other tests measured the overall function of the brain and brain size in some patients. in this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. in other words, all patients could eventually receive active drug. each patient's participation could last approximately 2 years. patients taking approved ad medications were permitted to participate in this study and continue taking these medications during the study. all patients who completed this study had the option to continue receiving semagacestat by participating in an open label study. preliminary results from this study (lfbc) (and another similar study lfan \[nct00594568\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. study drug was stopped in all studies. lfbc, lfan and open label lfbf (nct01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. the ct-registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.


Eligibility criteria:
inclusion criteria: * meets criteria for mild to moderate alzheimer's disease (ad) with mini-mental state examination score of 16 through 26 at visit 1 * modified hachinski ischemia scale score of less than or equal to 4 * geriatric depression scale score of less than or equal to 6 * a magnetic resonance imaging (mri) or computerized tomography (ct) scan in the last 2 years with no findings inconsistent with a diagnosis of ad * if female, must be without menstruation for a least 12 consecutive months or have had both ovaries removed. exclusion criteria: * is not capable of swallowing whole oral medication * has serious or unstable illnesses * does not have a reliable caregiver * chronic alcohol and/or drug abuse within the past 5 years * has ever had a active vaccination for ad

Keywords: alzheimer's disease