Kornimate/medical-research-clean huggingface dataset:
efficacy and safety evaluation of tavilermide ophthalmic solution for the treatment of dry eye

Conditions: Dry Eye Syndromes; Dry Eye Disease; Kerato Conjunctivitis Sicca

Summary: the purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * subject-reported history of dry eye disease in both eyes for at least 6 months; * history of use of artificial tear eye drops for dry eye symptoms; * total score of ≥40 on sande; * tfbut; * corneal fluorescein staining; * lissamine green conjunctival staining; * schirmer's test score. exclusion criteria: * have participated in a previous tavilermide (mim-d3) study; * have clinically significant slit lamp findings at visit 1; * have a history of lacrimal duct obstruction within 12 months of visit 1; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to visit 1.
study of the effectiveness of quetiapine for the treatment of alcohol dependency

Conditions: Alcoholism; Alcohol Abuse

Summary: the purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.

this study will investigate quetiapine fumarate xr (seroquel xr®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence. the immediate release form of quetiapine fumarate, seroquel xr®, is approved by the fda for treatment of schizophrenia and acute manic episodes associated with bipolar disorder. the extended release formulation (seroquel xr®) is also approved by the fda and is undergoing clinical investigation for the treatment of major depressive disorders, schizophrenia, generalized anxiety disorder, and alcohol dependence. treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric diagnoses. quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol use among alcoholics and drug dependent patients with co-morbid psychiatric illness.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 years old * dsm-iv diagnosis of current alcohol dependence as supported by scid module e * report "very heavy" drinking (10 or more drinks per drinking day for men or 8 or more drinks per drinking day for women) at least 40% of the days during the interval from day 31 to 90 prior to the initial screening visit (i.e. a total of 24 days of this 60-day period), with at least one day of "very heavy" drinking occurring within the last 2 weeks before screening * seeking treatment for alcohol dependence and desire reduction or cessation of drinking * able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures * females of child bearing potential must agree to use of at least one approved method of birth control, or must be surgically sterile or postmenopausal * able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits * able to understand written and oral instructions in english and to complete the questionnaires required by the protocol * can complete all psychological assessments required at screening and baseline * able to provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to study site, and have no plans to move within the next 3 months or unresolved legal problems; must provide contact information of family member, spouse, or significant other who can contact subject in case of missed appointment * breath alcohol concentration (bac) equal to 0.00 when s/he signed the informed consent document * must have an absolute neutrophil count of 1.5 x 109/l or greater. exclusion criteria: please contact site for additional information.

Keywords: alcoholism alcohol dependence quetiapine
a retrospective and prospective real-world study of molecular typing in the treatment of advanced thyroid cancer

Conditions: Advanced Thyroid Cancer Patients Who Received Target Therapy

Summary: this is a retrospective and prospective real-world clinical study of molecular typing in the treatment of advanced thyroid cancer. the retrospective study : patients with advanced thyroid cancer who received precise treatment in our hospital from january 2020 to december 2023 were retrieved. the number of previous treatment lines was not limited. patients who met the inclusion criteria were screened according to the inclusion and exclusion criteria. demographic information, clinical characteristics, tumor treatment history, medication regimen, adverse reactions, molecular test results, survival follow-up results and other data were collected. the prospective study : patients with advanced thyroid cancer who received precise treatment in our hospital from january 2024 to april 2027 were enrolled.


Eligibility criteria:
inclusion criteria: 1. patients volunteered to participate in this study and signed informed consent; 2. age: ≥ 18 years old, male or female; 3. histologically diagnosed locally advanced or recurrent / metastatic thyroid cancer that cannot undergo radical surgery meets one of the following requirements: 1. radioiodine-refractory thyroid cancer; 2. differentiated thyroid carcinoma not suitable for iodine therapy; 3. medullary thyroid carcinoma; 4. high-grade or poorly differentiated thyroid cancer; 5. anaplastic thyroid cancer; 4. patients who had undergone ngs testing (in our hospital or other hospitals) were able to query the test report or the key genetic test results recorded in the medical history (such as braf, ret, ntrk and other genetic test results). exclusion criteria: 1. patients who are participating in clinical trials of other drugs; 2. there is evidence that the patients are pregnant or lactating; 3. other situations that are not suitable for inclusion in this study.
strategies for inflammation and cardiovascular disease (cvd) prevention

Conditions: Atherosclerosis; Diabetes

Summary: the long-term goal of the proposed research is to identify and develop effective interventions to decrease persistent, low-level inflammation and risk of cvd. stress is a substantial contributor to inflammation, and interactions among stress, inflammation, body mass index, and health behaviors have been measured. mindfulness-based stress reduction (mbsr) is effective for stress reduction, has been shown to be effective for inflammation reduction in individuals with disease, and is a sustainable practice for individuals across the health spectrum. diet strategies are an effective means of reducing inflammation for some individuals, but may not be successful for many people, as evidenced by the steady rise in obesity rates. the specific aims of this study are to 1) test the effectiveness of mbsr compared to an established intervention of a nutrition enhancement (ne) intervention for the reduction of inflammation, and 2) test the effectiveness of mbsr compared to a non-intervention control conditions (con) for the reduction of inflammation. men and women 25-45 years of age will be randomly assigned to participate in mbsr (n=60) or diet (n=60) or con (n=60) interventions for 16 weeks. serum crp concentrations, additional inflammatory cytokines (tumor necrosis factor-a, interleukin-6), cortisol diurnal profiles, anthropometrics, dietary intake, and all components of the metabolic syndrome will be measured pre- and post-intervention to elucidate underlying mechanisms and to determine whether health benefits beyond inflammation reduction occur.


Eligibility criteria:
inclusion criteria: * elevated waist circumference or bmi exclusion criteria: * participation in calorie restricted diet in previous 30 d * participation in stress reduction program in previous 30 d * take blood pressure, lipid lowering or anti-inflammatory medications * hypertension * diabetes * heart disease
comparison between occlusal versus apical bent wires in patients on erich arch bar

Conditions: Maxillofacial Injuries

Summary: patients with jaw fractures requires placement of erich arch bar for immobilization of the fractured jaw. however, the usage of erich arch bar is associated with an increased in the incidence of mucosal trauma and plaque accumulation. conventionally, the ends of the wires has always been placed apical to the teeth. this study aims to determine if a change in the placement of the wire by directing it to the occlusal direction will reduce the incidence of mucosal trauma, plaque accumulation and if the stability of the erich arch bar will be affected by this intervention. the patients' teeth will be divided into left and right side and randomized into control side (wires end apically) and interventional side (wires end occlusally)


Eligibility criteria:
inclusion criteria: * 18 years - 60 years old. * full glasgow coma scale. * facial fractures requiring erich arch bar for 4 weeks duration * no functional deficit that will prevent tooth brushing. exclusion criteria: * all pathologic fractures due to cysts, tumors, and cancers * medical conditions that contraindicate the usage of arch bars (epilepsy, asthmatics)
prospective, single center switching study of 0.0015% tafluprost ophthalmic solution in primary open-angle glaucoma and ocular hypertension patients with corneal disorders (switching from 0.005% latanoprost ophthalmic solution)

Conditions: Glaucoma, Primary Open Angle

Summary: the objective of this study was to investigate the improving effect of corneal disorder in primary open-angle glaucoma and ocular hypertension patients, when switched from the 0.005% latanoprost ophthalmic solution (one drop at a time, once daily) to the 0.0015% tafluprost ophthalmic solution (one drop at a time, once daily). efficacy also was investigated.


Eligibility criteria:
inclusion criteria: * age of 20 years or older and those who was provided informed consent. * poag or oh patients whose iop did not exceed 22 mmhg at visit 0. * patients had treated with prostaglandin ophthalmic solution (0.005% latanoprost) for at least 3 months before enrollment. * patients who had corneal disorders due to the pg usage. (at least one eye had a score above 1 on the nei scale) * if only one eye was eligible, it was evaluated. when both eyes were eligible, then the eye with a higher nei score was selected for evaluation. * outpatients who visited the clinic on the designated day as instructed by the physician. exclusion criteria: * those with severe visual field disorder (mean deviation of 15 db or worse). * those who received corneal refractive surgery. * those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which affected the patient's ocular surface condition) within 3 months prior to enrollment. * any corneal abnormality or other condition preventing iop measurement. * those who used artificial tears to relieve dry eye symptoms. * those with severe dry eye, ocular allergy, ocular infection or ocular inflammation which considered affect interpretation of the results of the study. those who used systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than prostaglandin ophthalmic solution. * female patients who were pregnant, nursing or lactating. * those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the study medication. * those who wore contact lenses during the study period. * those who had participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.
the effects of inspiratory muscle training on endurance performance in trained athletes under normoxic and hypoxic conditions: a gender-based comprehensive study

Conditions: Hypoxia, Altitude

Summary: the powerbreathe™ plus: an inspiratory muscle training device (imt) with adjustable resistance. intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. resistance based on 60% of the pressure maximal inspiratory (pmi). progressive increase in resistance every week. four laboratory visits: 2 pre-tests and 2 post-tests. each pre- / post- test will go under normoxic and hypoxic conditions. measurements include pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. vo2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

the powerbreathe™ plus: an inspiratory muscle training device (imt) with adjustable resistance. intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. resistance based on 60% of the pressure maximal inspiratory (pmi). progressive increase in resistance every week. four laboratory visits: 2 pre-tests and 2 post-tests. each pre- / post- test will go under normoxic and hypoxic conditions. measurements include pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. vo2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

Eligibility criteria:
inclusion criteria: * inclusion: endurance trained athletes between 18 and 44 years old exclusion criteria: cardiovascular, metabolic and respiratory diseases, smoking history, prescription medication (two medication families are known to interfere with fc: * calcium channel blockers * beta-blockers two families are known to interfere during spirometry measurements: * inhaled beta-agonists * inhaled glucocorticoids)
popliteal sciatic nerve block: intraneural or extraneural?

Conditions: Hallux Valgus

Summary: aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. in addition we will evaluate the frequency of possible adverse effects.


Eligibility criteria:
inclusion criteria: * asa i-ii exclusion criteria: * neurological diseases * diabetes * allergies to used drugs * chronic pain in treatment * electrophysiological alterations at time zero analysis
endoscopic biliary co-axial stent placement plus/minus use of radiofrequency ablation (rfa) for clearance of occluded self expandable metal stents (sems) in patients with distal biliary obstruction from unresectable biliary-pancreatic malignancies

Conditions: Pancreatic Cancer; Unresectable Biliary-pancreatic Malignancies

Summary: the purpose of this study is to compare the effects good and/or bad of combining radiofrequency ablation with placement of a second stent, versus a second stent alone. the investigators will also look at the safety of the combination treatment, and see which treatment is better. in either case, the second stent will be placed inside the existing stent as is done in standard practice when treating a blocked stent for the first time.


Eligibility criteria:
inclusion criteria: * patients with any tumor obstructing the distal bile duct and causing an indwelling biliary sems * patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia) * age ≥ 18 years exclusion criteria: * have altered gastro-duodenal or hepatobiliary anatomy such that ercp is felt to be unacceptably technically difficult or unsafe * have additional sites of biliary strictures (intrahepatic/hilar) such that ercp stenting is felt to be unlikely to provide adequate clinical benefit * have cardiac pacemakers * have child b/c cirrhosis * are pregnant * are unsuitable for endoscopy (either because of hemodynamic instability, respiratory distress or unsafe hematological parameters such as refractory anemia \ 2.0) * have biliary strictures not technically amenable to endoscopic therapy

Keywords: stent placement biliary obstruction 14-260
probiotics to prevent relapse after hospitalization for bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of this study is to determine if taking a probiotic supplement versus a placebo will reduce relapse and improve the clinical course among participants who have been hospitalized for bipolar depression.


Eligibility criteria:
inclusion criteria: * age 18-65 (inclusive) * capacity for written informed consent * currently (or within the last 3 weeks) admitted to a sheppard pratt inpatient or day hospital program for symptoms of a depressive episode and a diagnosis bipolar disorder i or ii, most recent episode depressed per diagnostic and statistical manual of mental disorders 5th edition (dsm-5), the diagnosis of which is confirmed with the structured clinical interview for dsm-5 disorders (scid-5) * proficient in the english language * available to come to sheppard pratt towson for study visits after hospital discharge exclusion criteria: * depressive symptoms better accounted for by a diagnosis of major depressive disorder, schizoaffective disorder, schizophrenia, or disorder(s) other than bipolar disorder i or ii * dsm-5 diagnosis of intellectual disability or comparable diagnosis determined by previous version of the dsm * substance- or medically-induced mood symptoms at time of visit 1/baseline visit * dsm-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within three months prior to the visit 1/baseline visit * history of iv drug use * any clinically significant or poorly controlled medical disorder as determined by the principal investigator and/or the study physician (e.g., hiv infection or other immunodeficiency condition, uncontrolled diabetes, congestive heart failure) * a serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, concussion involving loss of consciousness, brain tumor, or other neurological disorder) * pregnant, planning to become pregnant, or breastfeeding during the study period * documented celiac disease * participated in any investigational drug trial in the 30 days prior to the visit 1/baseline visit * receipt of electroconvulsive therapy (ect) in the 30 days prior to the visit 1/baseline visit or planned ect after hospital discharge

Keywords: bipolar disorder bipolar depression depressive episode probiotic supplement probiotics relapse prevention rehospitalization
lidocaine compared to magnesium sulfate to prolong spinal anesthesia: non-inferiority randomized clinical trial

Conditions: Anesthesia; Pain

Summary: this study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.

both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia. the number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies. adverse effects of lidocaine are different from magnesium sulfate's. lidocaine has a wider therapeutic interval with fewer side effects, including: drowsiness, feeling anxious, feeling cold, nervous, numbness and tingling, signs and symptoms at injection site, twitching. magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.

Eligibility criteria:
inclusion criteria: * will receive spinal anesthesia for turp por histerectomy exclusion criteria: * protocol violation; * severe adverse events; * change to general anesthesia or addition of epidural anesthesia; * complete or partial spinal block failure; * mental status alteration (agitation, confusion, loss of conciousness).
augmentation of standard psychotherapy with a habit change app

Conditions: Diabetes; Substance Use Disorders; Anxiety Disorders; Depression

Summary: the goal of this clinical trial is to document the efficacy of using a habit change application (app) as an adjunct to standard psychotherapy among individuals with diabetes receiving mental health treatment for depression, anxiety, or substance use disorders. the main questions it aims to answer are: question 1: when behavioral health treatment is augmented with a habit change app for between visit care, does the use of this tool improve mental and behavioral health outcomes? question 2: are there certain populations who benefit more from using a habit change app? question 3: does use of a habit change app impact healthcare utilization and costs? exploratory research question: does use of a habit change app impact physical health outcomes, including a1c levels, blood pressure, and weight? participants selected to receive the habit change app will be asked to track goals that they set for themselves in adjunct to their current behavioral health treatment; those selected for treatment as usual will have no additional steps to take. researchers will compare the groups to see if there are different outcomes in symptom reports and healthcare utilization.

as part of this research, participants with a diagnosis of diabetes and depression, anxiety, and/or substance use disorder will be randomized to one of two treatment groups: (1) habit change and (2) treatment as usual (tau). all participants will currently be engaged in behavioral health treatment. participants in the habit change arm will obtain access to a habit change app and set their personal health goals in the app to track throughout the study period. participants in the tau arm will continue to engage in their behavioral health treatment as usual and will not be provided access to the habit change app. participants randomly assigned to the habit change arm will be asked to track behaviors related to their specific goals on a daily basis through the app and will be allowed to engage with the app freely. outside of using the app, participants will not be asked to engage in any additional activities beyond those typically engaged in for behavioral health treatment (e.g., completion of mental and behavioral health outcome measures).we will be recruiting up to 600 participants as part of this research study (300 per treatment arm).

Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * are being seen by a clinician for depression, anxiety and/or substance use disorder * speak english * have an apple device to download the habit change app exclusion criteria: * unable to provide informed consent

Keywords: mobile health randomized control trial mental health diabetes