Kornimate/medical-research-clean huggingface dataset:
neurotherapeutics as an adjunctive approach to enhance exposure outcomes in anxiety

Conditions: Anxiety Disorders

Summary: anxiety disorders are highly prevalent and costly to the individual and society. exposure-based cognitive behavioral therapy (cbt) is the gold-standard intervention for anxiety disorders, although this approach does not fully reduce symptoms for all individuals. therefore there is a need for innovative intervention approaches. one approach to augment and improve existing therapies would be to enhance the neurocognitive basis of fear extinction processes, which are the model on which treatments are based. enhancing these processes may be possible through computerized cognitive training techniques which target executive functioning, the cognitive processes that help people manage complex cognitive activities. the proposed project is a proof-of-concept pilot study investigating the potential for training of executive functioning to improve anxiety-related outcomes. individuals with elevated levels of social anxiety will be randomized to single-session cognitive enhancement training (cogent) or sham training program (st). all participants will complete a single speech session where they present three 7-minute impromptu speeches and rate their anxiety at specific intervals. participants will then complete the cogent paradigm and affective processing task while undergoing fmri.


Eligibility criteria:
inclusion criteria: 1. screened positive for anxiety symptoms 2. between the ages of 18-55, inclusive. 3. have signed informed consent document(s) indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study. 4. have sufficient proficiency in english language to understand and complete interviews, questionnaires, and all other study procedures. exclusion criteria: 1. evidence of psychosis, bipolar disorder, or severe substance use disorder based on clinical cutoffs on self report measures 2. current neurological conditions based on brief medical history 3. current psychotherapy for anxiety or psychotropic medications 4. mri contraindications including: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit), persons who have ever been a metal worker/welder, history of eye surgery/eyes washed out because of metal, vision problems uncorrectable with lenses, inability to lie still on one's back for 60 minutes; prior neurosurgery; tattoos with metal dyes, unwillingness to remove body piercings, and pregnancy. 5. active suicidal ideation endorsed on the depression self-report measure.
single port endoscopic breast conserving surgery

Conditions: Breast Conserving Surgery; Endoscopic Surgery

Summary: the center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.

data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. this study investigates the results of endoscopic breast- conserving surgery(e-bcs) versus conventional breast-conserving surgery(c-bcs) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.

Eligibility criteria:
inclusion criteria: 1. breast cancer confirmed by pathology； 2. tumor \<5 cm, tnm stage 0-ii； 3. single port endoscopic or traditional open surgery; (4)20 to 70 years old female patients. exclusion criteria: 1. bilateral breast cancer; 2. reconstruction after breast conserving surgery ; 3. basic information is not complete； 4. breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.

Keywords: breast conserving surgery single port endoscopic early breast cancer
safety planning intervention telehealth service model in emergency departments

Conditions: Suicide; Suicidal Ideation

Summary: the purpose of this study is to evaluate the effectiveness and implementation of a suicide prevention strategy delivered via telehealth in emergency departments. we will compare implementation of the safety planning intervention plus follow-up calls (spi+) delivered by emergency department (ed) staff to spi+ delivered via ed referral to an off-site suicide prevention consultation center (spcc).

individuals at high risk for suicide often present to acute care settings, such as emergency departments (eds), and then typically are hospitalized or referred for outpatient mental health treatment. patients are at increased risk of suicide attempts and suicide following an ed visit and nearly half do not attend outpatient treatment. brief, evidence-based clinical interventions, such as the safety planning intervention with post-discharge telephone follow-up (spi+), can reduce suicide risk, decrease hospitalizations, and increase engagement in outpatient services for suicidal patients discharged from the ed. leveraging insights from implementation science and collaborative care, we propose a model in which ed staff will connect patients at risk for suicide to ed-credentialed mental health clinicians who are located external to the ed. these off-site clinicians will provide spi+ via telehealth for ed patients prior to discharge and provide follow-up services after ed discharge as part of an innovative suicide prevention consultation center (spcc). all participating eds will begin in the enhanced usual care phase, in which ed staff will deliver spi+ to suicidal patients. eds will then be randomized in pairs to begin referral to the spcc in 3 month intervals. we will also conduct a cost evaluation to help determine scalability and sustainability.

Eligibility criteria:
aim 1/aim 3: inclusion criteria: * ed visit at one of our participating sites for a suicide-related event or determined to be at risk for suicide per the electronic health record (ehr) and ed clinical staff * 18 years of age or older * not admitted to an inpatient hospital following the index ed visit as documented in the ehr exclusion criteria: - inpatient admission following the index ed visit per the ehr aim 2: inclusion criteria: * ed clinician or leader at one of our participating sites, or ed patient who was referred to the spcc * 18 years of age or older * able to communicate in english * willing to give informed consent exclusion criteria: * patients who are at imminent risk of suicide or acutely psychotic at the time of the interview, requiring emergency services and/or precluding ability to provide informed consent * patients without a phone for contact

Keywords: safety planning emergency department risk assessment follow-up contact implementation strategies telehealth
study of the safety, tolerability and immunogenicity of an intranasal influenza vaccine administered to healthy adults

Conditions: Flu, Human

Summary: the objectives of this study were to assess the safety and tolerability of dcb07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza ha antigen (7.5μg ha of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive phase 2 studies. this was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza ha alone. the 4 treatment cohorts were given dcb07010 in a dose- escalating manner.


Eligibility criteria:
inclusion criteria: 1. non-smoking adult aged between 20-40 years old; 2. physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-rays, ophthalmoscopy, cardiac echo, and electrocardiogram; 3. body mass index (bmi) between 18.5 and 25, inclusive, (bmi will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]); 4. normal hematology, biochemistry and urinalysis determinations; 5. subject is willing and able to comply with study procedures and sign informed consent exclusion criteria: 1. subject with serious underlying chronic illness; 2. documented evidence of allergic rhinitis; 3. subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment; 4. immunosuppressed subjects as result of illness or treatment; 5. female subject of childbearing potential who: * is lactating; or * has positive urine pregnancy test at visit 2 or visit 3; or * refuse to adopt reliable method of contraception during the study; 6. subject received blood products or immunoglobulin within 3 months prior enrollment; 7. subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment; 8. subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment; 9. subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product; 10. subject has previously experienced anaphylaxis; 11. subject has allergy to eggs or prior influenza vaccine; 12. subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment; 13. subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment; 14. subject with body temperature high than 38°c within 3 days prior to enrollment; 15. subject with documented history of bell's palsy or neurological disorder. 16. subject with documented history of diarrhea within one month prior to study enrollment 17. a positive test for hiv antibody. 18. subject has received chinese medication or herbal medication within 28 days prior to enrollment
obstructive sleep apneas in elderly:neuroimaging changes and neurocognitive function before and after treatment

Conditions: Sleep Apnea

Summary: in the near future more than 20% of the european population will be over 65 years old and the prevalence of obstructive sleep apnea (osa) in this aged population is known to be higher than 50%. osa is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (sbd) in the elderly has scarcely been observed. the aim of this study is to investigate cognitive performance in elderly osa patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (cpap) treatment.

patients: we will include consecutive patients with a diagnosis of severe osa (ahi\> 30) without significant comorbidities or excessive daytime sleepiness (epworth ≤ 12). patients will be randomized to cpap treatment or conservative treatment. methodology: we will assess at baseline and after 3 months of treatment: 1. neuroimaging by mri 2. neurocognitive function with an extensive neuropsychological battery assessing principally memory, attention and executive functions (trail-making test a and b, rey auditory verbal learning test, digit span, digit symbol), 3. biological markers of inflammation and endothelial dysfunction. patients included in the study will be monitored and followed for three months. they will be examined at the time of inclusion, after two and six weeks and at the end (12 weeks) for clinical monitoring and the evaluation of adaptation to treatment and compliance.

Eligibility criteria:
inclusion criteria: 1. men and women ≥ 65 years old. 2. patients diagnosed with osa with an apnea-hypopnea index per hour \>30. 3. patients with an epworth sleep scale score ≤ 12 (without excessive daytime sleepiness). 4. signed written informed consent. exclusion criteria: 1. patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric. 2. any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions. 3. mini mental state exam (mmse) \<24. 4. any mri exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body. 5. previous cpap treatment. 6. psycho-physical inability to complete questionnaires. inadequate visual and auditory acuity will be excluded. 7. presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, rem behavior disorder and restless leg syndrome. 8. patients with \> 50% of central apneas or the presence of cheyne-stokes respiration. 9. history of alcohol abuse or dependence.
a study to evaluate the pharmacodynamic effects of single-dose co-administration of lx4211 with januvia® in type 2 diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: this study is intended to evaluate the pharmacodynamics, safety, and tolerability of lx4211 when administered concurrently with sitagliptin (januvia®) in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 65 years of age * history of type 2 diabetes mellitus for at least 3 months prior to screening, with hgba1c values of 6.5 to 10.5% and c-peptide ≥1.0 ng/ml * body mass index (bmi) ≤45 kg/sq m * willing and able to self-monitor blood glucose * able to provide written informed consent exclusion criteria: * history of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes * current use of any blood glucose lowering agent other than metformin * history of renal disease or clinically significant abnormal kidney function tests at screening or day -2 * presence of active hepatic disease or clinically significant abnormal liver function tests at screening or day -2 * history of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of day -2 * history of clinically significant cardiac arrhythmias within 1 year of day -2 * congestive heart failure and/or new york heart association (nyha) class iii or iv symptoms of heart failure * subjects with uncontrolled stage 3 hypertension * history of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of day -2 * history of alcohol or drug abuse within 12 months of screening * history of bowel resection \> 20 cm, any malabsorptive disorder, severe gastroparesis, and gi procedure for the purpose of weight loss that would slow gastric emptying * history of hiv or hepatitis c * major surgery within 3 months of day -2 or any planned surgery during the study * history of any active infection within 2 weeks of day -2 * history of pancreatitis * history of any malignancy within the last 5 years which would affect the diagnosis or assessment of lx4211 or sitagliptin * history of any serious adverse reaction or hypersensitivity to lx4211 or sitagliptin * presence of any clinically significant physical, laboratory, or ecg findings or any concurrent condition at screening that may interfere with the study in the opinion of the investigator * triglycerides \> 1000 mg/dl at screening or day -2 * donation or loss of \>400 ml of blood or blood product within 8 weeks prior to day -2 * use of any tobacco product for the duration of study participation * use of corticosteroids within 2 weeks of day 1 * use of digoxin or warfarin within 2 weeks prior to screening
bcaa supplemental study

Conditions: Cirrhosis

Summary: the central hypothesis of this study is that bcaa supplementation and bcaa supplementation plus low-intensity activity will improve muscle mass and hrqol in cirrhotic patients compared to usual care

the purpose of this study is to look at the impact of including a physical activity program and/or a nutritional supplement along with your regular care. the nutritional supplement used in this study consists of branched-chain amino acids (bcaas). bcaas are found in certain foods and are readily available as dietary supplements. the investigators in this study will look at how the physical activity and nutritional supplement program might affect patients' health outcomes, and if this program can maintain or even increase muscle mass in patients with cirrhosis. participants will be randomized in three groups: 1. standard care: if the participant is randomized to this group, they will receive the same medical care for their cirrhosis as they would if they were not participating in the study. the doctor will provide them with some general information about healthy diet and exercise. they will also be asked to keep an exercise log of the type of physical activity they do on your own. 2. nutritional supplement: bcaas: if the participant is randomized to this group, they will be provided with bcaa powder to take during the 12 weeks of the study. they will be asked to take 7 teaspoons per day. they will take 2-3 teaspoons after each meal. the doctor will also provide them with some general information about healthy diet and exercise, and they will also be asked to keep an exercise log of any physical activity they do on your own. 3. nutritional supplement and supervised physical activity: if the participant is randomized to this group, they will be provided with bcaa powder and be asked to participate in one hour per week of supervised fitness instruction at the loyola center for fitness. the fitness instruction will consist of low-impact aerobic exercise such as walking or riding an exercise bicycle. they will also be given a list of exercises to perform at home at least two times during the week and be asked to keep an exercise log of their physical activity. the doctor will provide them with some general information about healthy diet and exercise.

Eligibility criteria:
inclusion criteria: 1. cirrhosis with ascites 2. meld-na score\<25 exclusion criteria: 1. pregnancy 2. inability to engage in low-intensity physical activity due to any condition 3. active acknowledged alcohol or substance abuse 4. inability to complete protocol assessments.
clinical comparison of application of curcumin gel in pain management after free gingival graft harvesting

Conditions: Palate; Wound

Summary: the aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.


Eligibility criteria:
inclusion criteria: 1. systematically healthy patient (american society of anesthesiology class i and ii). 2. male or female 3. patients with mucogingival defects scheduled for free gingival graft. 4. patients with good oral hygiene. exclusion criteria: 1. patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated. 2. history of recent periodontal surgery at the donor site. 3. smokers. 4. pregnancy and lactation. 5. patients allergic to the used agents, 6. severe gagging reflex. 7. inability or unwillingness to provide informed consent.
sensory re-training in patients with chronic neck pain

Conditions: Neck Pain; Cervical Pain; Neck Muscle Issue; Neck Pain, Posterior; Cervical Pain, Posterior

Summary: it is known that tactile acuity and proprioceptive sense decrease in patients with chronic neck pain. however, sensory re-training in patients with chronic neck pain has not been given sufficient importance. the effects of proprioceptive and tactile acuity training on pain intensity in patients with chronic neck pain will be compared in this study. eligible participants will be divided into three groups as follows: proprioceptive training group (ptg), tactile acuity training group (tag), and control group (cg). the randomization will be performed using the block randomization method to obtain an equal number of participants in the groups. each participant will be evaluated two times at a 4-week interval. participants will be evaluated regarding subjective pain intensity by using a numerical rating scale, temporal summation, and conditioned pain modulation using an algometer (jtech medical-algometer commander, usa). neck proprioception exercises will be applied to the patients in the ptg at 3 days a week for 4 weeks. tactile acuity training will be applied to the patients in the tag 3 days a week for 4 weeks. between the two assessments, the control group will not receive any treatment.


Eligibility criteria:
inclusion criteria: * to be aged between 20-60 years old * pain limited to the posterior of the cervical region. * pain that lasts longer than 3 months * pain severity of 3 or higher on the visual analog scale exclusion criteria: * malignant tumor in any part of the body (no screening will be performed for the presence of tumor and patients diagnosed with tumors before the study will not be included). * vertebral fractures * fibromyalgia * chronic fatigue syndrome * history of surgery in the neck or shoulder area * radicular pain * neurological deficit of disc pathologies * spinal stenosis * spondylolisthesis * pronounced cervical kyphosis * significant scoliosis involving the cervical region

Keywords: oculomotor exercises neck pain cervical pain sensory re-training