Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of he10 for dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate the efficacy and safety of he10 eye drop for the patients with moderate to severe dry eye syndrome.

this study is to compare the efficacy and safety of he10 and restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority phase iii clinical trial.

Eligibility criteria:
inclusion criteria: * corneal staining score of ≥2(oxford grade) * schirmer test score (without anesthesia) \< 10 mm/5 min in either eye * tear break-up time is 10 seconds or less * screening both eyes, the corrected visual acuity is 0.2 or more exclusion criteria: * current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status * the patients with systemic or ocular disorders affected the test result * being treated with systemic steroid * history of eyeball surgical operation within 3 months of screening visit * wearing contact lenses within 2 weeks of screening visit * be a use or used punctual plug within 1 month of screening vist * use of cyclosporine eye drop within 3 weeks * pregnancy or breastfeeding * intraocular pressure \> 25 mmhg * abnormal eyelid function : disorders of the eyelids or eyelashes
quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.

Conditions: Apathy; Behavior; Frontotemporal Dementia

Summary: the purpose of this study is to provide relevant quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.

the investigators try to measure the amount of goal-directed behaviour and to detect the pattern of apathy. the main objective of this pilot phase is to select the variables of goal-directed behaviour from the list of metrics providing by the multimodal acquisition system in healthy subjects and patients with frontotemporal dementia.

Eligibility criteria:
inclusion criteria: * diagnosis of frontotemporal dementia (ftd) according to diagnostic criteria reported by rascovsky et al. (2011). * understanding of the instructions and capacity to realize the cognitive tasks. * capacity to read, to understand and to sign legal document of information * capacity for informed consent for research, capacity to sign consent * mmse score \> 20 * absence of other cerebral pathology. * absence of psychiatric disease interfering with the assessment of the tests * absence of excessive psychotropic use * access to national healthcare insurance * accompanied with a caregiver exclusion criteria: * excessive psychotropic use * incapacity or refusal to realize the experimental tasks * subject deprived of freedom by an administrative or court order * subject under legal protective measure. * incapacity for informed consent for research * participation in another biomedical research * airway obstruction risk * reduction of activity not attributable to another chronic pathological condition

Keywords: apathy goal-directed behavior quantitative evaluation sensor ethogram
ninth dorsal osteopathic visceral manipulation d9

Conditions: Osteopathia; Manipulation

Summary: the aims of this study is to verify that the vertebral manipulation of dorsal level d9 influences the pancreas biochemical and endocrinology blood values.

a longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. in this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the catholic university of murcia.the blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.

Eligibility criteria:
inclusion criteria: * students between 18-27 years old * healthy persons * acceptance of informed consent exclusion criteria: * pancreatitis * diabetes i,ii type * anemia * alcohol intake for 12 hours prior.

Keywords: thrust technique blood levels pancreas ninth vertebra manipulation
positron emission tomography in prostate cancer

Conditions: Prostate Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography using carbon-11 acetate, may help find metastases from prostate cancer and may help predict whether prostate cancer will come back after treatment. purpose: this clinical trial is studying how well positron emission tomography using carbon-11 acetate works in finding metastases and predicting recurrence in patients with prostate cancer who are at risk for recurrence after treatment.

the overall goal of this project is determination of the role of pet in patients with newly diagnosed medium- and high-risk prostate cancer in whom the standard clinical and imaging workup is negative. thus, the incremental value of pet will be determined in this important group.

Eligibility criteria:
inclusion criteria * newly diagnosed prostate cancer * has completed conventional staging examinations, including biopsy with gleason score, ct scan of the abdomen and pelvis, and whole-body bone scintigraphy and conventional staging examinations negative * candidate for curative radical prostatectomy or curative radiotherapy or staging lymphadenectomy prior to surgery * deemed to be at medium or high risk for recurrence after initial curative treatment, as defined by 1 of the following criteria: * gleason score 7 and prostate-specific antigen (psa) 10-20 ng/ml * gleason score ≥ 8 and psa \< 10 ng/ml * gleason score ≥ 8 and psa \> 10 ng/ml * any gleason score and psa \> 20 ng/ml exclusion therapy: * not a candidate for treatment by surgery or radiation therapy with curative intent * inability to give informed consent * patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
a family-based intervention to improve pap test screening among under-screened chinese american immigrant women

Conditions: Cervical Cancer; Healthy Women

Summary: the purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on pap test screening intention and behaviors, pap test self-efficacy, and perceived benefits and barriers to pap test screening among chinese american immigrant women. these data specific to the impact of the involvement of an influential person on pap test screening could be used to develop successful cancer prevention programs that target the specific needs of chinese populations.

the importance of the support from family, spouse, friends, or significant others has been noted among chinese american immigrant women (caiw), but little attention has been paid to the effects of family-based (fb) interventions, especially for cervical cancer screening. understanding the role of caiw's family in promoting pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. the objective of this study is to test the effects of a fb intervention on pap test intention and behaviors, pap test self-efficacy, and perceived benefits and barriers to pap tests among under-screened caiw aged 21-65. this pilot test of the fb intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. interventions will be delivered by bilingual and bicultural caiw trained facilitators. post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.

Eligibility criteria:
inclusion criteria: * a first-generation chinese american * no previous cervical cancer screening within the past 3 years * no total hysterectomy * no history of cervical cancer * able to read english, simple chinese, or traditional chinese. exclusion criteria: * not a chinese american immigrant * had total hysterectomy * had history of cervical cancer * not able to read english or chinese
dexmedetomidine and esmolol early post operative cognitive dysfunction

Conditions: Cognitive Dysfunction

Summary: dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression. from a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine. esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages

the study will be a randomized double blinded study and will be carried by the department of anaesthesia at beni-suef university hospital after obtaining approval from local research and ethical committee. written informed consent will be obtained from each patient before operation. aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries

Eligibility criteria:
inclusion criteria: patients aging 20-50 years asa physical status i-ii . males , females exclusion criteria: 1. hypertensive patient 2. patients receiving sedatives as midazolam. 3. patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases. 4. patients with cerebrovascular diseases. 5. patients with impaired kidney function. 6. patients with history of chronic liver diseases. 7. patients with asthma, chronic obstructive lung diseases. 8. patients with diabetes mellitus, coagulation disorders, pregnancy. 9. patients with history of allergy to the drugs used in the study or patients with substance abuse .
comparison of continuing olanzapine to switching to quetiapine in overweight or obese patients with schizophrenia and schizoaffective disorder

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purposes of this study are to determine: * the effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight. * the safety of olanzapine as compared to quetiapine.


Eligibility criteria:
inclusion criteria: * you must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder * you must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period exclusion criteria: * you are a woman and are pregnant or breastfeeding * you have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (note: if you are uncertain about a particular condition, please discuss it with your physician.) * you have a history of allergic reaction or intolerance to olanzapine or quetiapine
genomic and proteomic study of richter syndrome (cgpsr)

Conditions: Richter Syndrome

Summary: biological study on richter syndrome (rs), an agressive lymphoma that arises from chronic lymphocytice leukemia (cll). rs presents with the same histological aspect as primitive diffuse large b-cell lymphoma (dlbcl), but is associated with a poor prognosis, due to chemorefractoriness. this study aims at understanding the biological determinants of chemotherapy resistance in richter syndrome.

with the help of the french national research group on cll (filo / french innovative leukemia organization), the investigators are currently gathering fresh frozen cell pellets at cll stage, and lymph node biopsies at richter stage. the investigators also gathered lymph node biopsies from dlbcl, as a reference group. the investigators will perform genomic and proteomic comparative studies between cll and richter, as well as between richter and primitive dlbcl, to understand the biological determinants of clonal evolution and chemorefractoriness of richter syndrom.

Eligibility criteria:
inclusion criteria: * diagnosis of a diffuse large b-cell lymphoma arising in the context of a chronic lymphocytic leukemia (group 1) or diagnosis of a primitive diffuse large b-cell lymphoma (group 2), or diagnosis of a diffuse large b-cell lymphoma arising in a context of small cells lymphoma, excluding cll (group 3), or benefit from a diagnostic lymph node biopsy that did not reveal any tumor involvment (primitive or metastatic) (group 4). * patients must benefit from a lymph node biopsy at diagnosis. * patients must be followed by a filo (french innovative leukemia organization) member * histology of diffuse large b-cell lymphoma or hodgkin histology. * suitable clinical data available. * samples must meet the following requirement :rin (rna integrity number) \> 5 et din (dna integrity number) \> 6.5. exclusion criteria: • samples that do not meet the inclusion criteria (insufficient clinical data, analysis impossible due to insufficient sample quality).

Keywords: richter syndrome genomics proteomics chemotherapy resistance
y transconjunctival approach in open reduction of zygomatic maxillary complex fracture

Conditions: Zygomatic Fractures

Summary: this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex. postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.


Eligibility criteria:
inclusion criteria * patients with zmc fractures that requires open reduction with internal fixation. * adult patient between 20 and 50 years with no gender predilections. exclusion criteria * existing lacerations in the inferior and lateral periorbital regions. * comminuted fracture with bone loss. * existence of infection at the fracture line. * presence of acute and chronic conjunctival diseases.
gene therapy study in severe hemophilia a patients with antibodies against aav5

Conditions: Hemophilia a; Gene Therapy; Clotting Disorders; Blood Disorder

Summary: this study is being conducted by biomarin pharmaceutical inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an adenovirus-associated virus (aav) based gene therapy vector) in severe hemophilia a patients with pre-existing antibodies against aav5.


Eligibility criteria:
inclusion criteria: 1. males ≥ 18 years of age with hemophilia a and residual fviii levels ≤ 1 iu/dl as evidenced by medical history, at the time of signing the informed consent. 2. detectable pre-existing antibodies against the aav5 vector capsid as measured by aav5 total antibody elisa. 3. subject must have been on prophylactic fviii replacement therapy for at least 12 months prior to study entry. 4. no previous documented history of a detectable fviii inhibitor, and results from a bethesda assay or bethesda assay with nijmegen modification of less than 0.6 bethesda units (bu) (or less than 1.0 bu for laboratories with a historical lower sensitivity cutoff for inhibitor detection of 1.0 bu) on 2 consecutive occasions at least one week apart within the past 12 months (at least one of which should be tested at the central laboratory). 5. sexually active participants must agree to use an acceptable method of effective contraception. participants must agree to contraception use for at least 12 weeks post-infusion. exclusion criteria: 1. any evidence of active infection including covid-19, or any immunosuppressive disorder, except for hiv infection. hiv positive patients who meet all other eligibility criteria may be included if they have a cd4 count \> 200/mm3 and an undetectable viral load (unquantifiable viral load as defined as less than the limit of quantification by the testing laboratory's assay is permitted) while receiving an antiretroviral therapy (art) regimen that does not contain efavirenz or another potentially hepatotoxic art. 2. evidence of liver dysfunction as assessed by liver tests and most recent, prior fibroscan or liver biopsy showing significant fibrosis of 3 or 4 as rated on a scale of 0-4 on the batts-ludwig (batts 1995) or metavir (bedossa 1996) scoring systems, or an equivalent grade of fibrosis if an alternative scale is used. 3. chronic or active hepatitis b or c as evidenced by testing at screening. 4. active malignancy, except non-melanoma skin cancer, or history of hepatic malignancy. 5. any condition that, in the opinion of the investigator or sponsor would prevent the patient from fully complying with the requirements of the study (including corticosteroid treatment and/or use of alternative immunosuppressive agents outlined in the protocol) and/or would impact or interfere with evaluation and interpretation of subject safety or efficacy result.

Keywords: hemophilia a blood coagulation disorders, inherited blood coagulation disorders hematologic diseases coagulation protein disorders hemorrhagic disorders genetic diseases, inborn factor viii coagulants aav5 antibodies
an open label study of a peptide vaccine in patients with stage iii colon cancer

Conditions: Colonic Neoplasms; Colorectal Neoplasms

Summary: ep2101 is a new cancer vaccine containing 10 different peptide antigens. the vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. this study will test the safety and measure the level of immune stimulating capability of ep2101 in patients with colon cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of colon cancer, stage iii * at least four weeks following prior standard treatment, with no evidence of disease * must use adequate birth control exclusion criteria: * prior cancer vaccine therapy or concurrent participation in any other investigational study * a history of hiv, hepatitis b or c, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment * a history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine * women who are pregnant, intend to become pregnant, or who are breast feeding

Keywords: vaccine colon cancer colorectal neoplasm colonic cancer colon cancer cancer of the colon
acute ventilatory response to hypoxia during sedation with dexmedetomidine compared to propofol in healthy male volunteers

Conditions: Hypoxia; Anesthetics; Conscious Sedation; Hypercapnia

Summary: the overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study. 6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

Eligibility criteria:
inclusion criteria: 1. male 2. age 18-40 3. american society of anesthesiologist´s classification (asa) 1, i.e. healthy 4. no medication 5. no allergies 6. non-smoker/no snuff, i.e. no nicotine intake 7. normal weight, bmi \<26 exclusion criteria: snoring

Keywords: dexmedetomidine propofol hypoxic ventilatory response hypercapnic ventilatory response
smart heart: study of mhealth apps to reduce cancer-treatment effects on the heart

Conditions: Acute Leukemia in Remission; Hematopoietic Cell Transplantation Recipient; Lymphoma

Summary: this pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.

primary objectives: i. determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (hct) survivors in a randomized cardiovascular (cv) risk reduction mobile health (mhealth) counseling intervention. ii. develop and refine a protocol to engage participants using an existing social medial platform and commercially available mhealth tools to reinforce lifestyle goals. outline: participants are randomized to 1 of 2 groups. intervention group: participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. they also have access to mhealth apps including fitbit and healthwatch that provide feedback on physical activity and diet. control group: participants receive general information about physical activity and diet, and access to fitbit and healthwatch. after completion of study treatment, participants are followed up at 2 months and at 1 year.

Eligibility criteria:
inclusion criteria: * prior diagnosis of an acute leukemia or lymphoma or any receipt of hct for a malignant condition. * at time of approach, \>= 5 years from initial cancer diagnosis or \>= 5 years from first hct, whichever is later. * currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are not eligible). * able to read, write, and speak english. * access to smart phone or computer with internet access. * presence of at least 1 cv risk factor: * currently on medication for hypertension, or * currently on medication for cholesterol or triglyceride, or * currently on medication for diabetes, or * currently not physically active (self-reported average \< 30 minutes/day), or * currently smoking. * ability to understand and the willingness to provide informed consent. exclusion criteria: * pre-existing ischemic heart disease (includes angina if documented in electronic medical record \[emr\]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing). * active systemic treatment for graft versus host disease. * currently pregnant. however, participants enrolled who become pregnant after randomization can remain on the study.