Kornimate/medical-research-clean huggingface dataset:
telehealth pilot for veterans with chronic multi-symptom illness.

Conditions: Chronic Multisymptom Illness

Summary: the objective of this pilot study is to examine the feasibility, safety, and acceptability of a telehealth meditation and physical activity (map) intervention among veterans with chronic multi-symptom illness.

this pilot study innovatively merges with ongoing clinical practice at the war related illness and injury study center to explore the utility of new va technologies and distance-bridging approaches for administering a remote intervention that promotes health behaviors (e.g., physical activity and meditation, called mental and physical training or map). not only does this study intend to examine the feasibility of using these tools within the home setting and integrating these practices into the weekly lives of veterans, but it also aims to determine the best way to administer this type of intervention by comparing a directed map (dmap) intervention arm to a self-guided map (sgmap) intervention arm. understanding how much guidance to provide veterans during their path towards recovery is important since we hope that this pilot study will offer not only evidence that these practices can be administered without supervision but also reveal that giving veterans the right tools (exercise and meditation app on tablet), guidance (directed text message or holistic goals), and support (video-chat health coaching) can have measurable benefits on symptom severity and function.

Eligibility criteria:
inclusion criteria: * previously deployed veterans * experiencing chronic multisymptom illness defined using the fukuda criteria. * able to engage in physical activity * has a smart phone * co-enrolled in the wriisc data repository study exclusion criteria: * excessive alcohol consumption (audit score \>= 4 (men); audit score \>= 3 (women)) * current or previous drug use past 90 days. * current prominent suicide or homicidal ideation * recent exposure to trauma * acute or unstable illness * dementia or significant cognitive impairments

Keywords: telehealth veterans exercise meditation health coaching
a follow up study to protocol 101/2 - continued treatment by ipl344 iv

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by ipl344 iv administered once a day in up to 15 participants with als. the study is designed to determine the safety, tolerability and initial efficacy of ipl344, administered once a day, by iv infusion for up to 36 months


Eligibility criteria:
inclusion criteria: 1. male or female participants ages ≥ 18 to 75 years. 2. participants that have completed study protocol #101/2 3. a written informed consent signed prior to any study procedure being performed 4. medically capable to undergo study procedures at the time of study entry exclusion criteria: 1. participants that did not participate or did not complete 28 treatment days of study protocol #101/2. 2. concurrent therapy, that in the pi's opinion, would interfere with the evaluation of the safety or efficacy of the study medication 3. presence of any other condition or circumstance that, in the judgment of the investigator, might contraindicate or increase the risk to the participant. 4. females must not be lactating or pregnant at screening or baseline (as documented by a negative serum pregnancy test from protocol 101/2) 5. women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial
the pectoral block for breast augmentation surgery

Conditions: Pain, Postoperative; Anesthesia; Regional

Summary: the pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (pec) 1 block. this block has not been well characterized in terms of its blocking effects on motor and sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). this clinical trial is divided into two sections: a volunteer study and a patient study. for the volunteer study, the aim is to assess the sensory territory affected by injection of local anesthetics through a pec 1 block and to assess motor function in terms of strength of adduction of the affected limb using a dynamometer. in a prospective, randomized, controlled and double blind study, the aim is to assess the postoperative pain relieving properties of the pec 1 block in patients undergoing bilateral breast augmentation surgery.


Eligibility criteria:
inclusion criteria: * breast augmentation surgery * registration at régie d'assurance maladie du québec (ramq) (social services) exclusion criteria: * known bleeding disorder * anticoagulant intake * infection at site of pec 1 block * pregnant or breast-feeding women * allergy to bupivacaine * chronic pain including fibromyalgia with regular analgesic consumption * under recreational drugs or alcohol at doses above canadian recommendations * muscle relaxants intake * patients already operated for breast augmentation or mastectomy
irrisept c.acnes study

Conditions: Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty

Summary: a prospective, randomized, controlled trial comparing an irrisept antiseptic irrigation with 0.05% chlorhexidine gluconate versus standard of care prophylaxis chlorohexidine wipes

the purpose of this prospective randomized control trial is to access outcomes of positive culture growth of c. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.

Eligibility criteria:
inclusion criteria: 1. patient has signed the irb-approved informed consent form specific to this study prior to undergoing any research related procedures 2. patient can read and understand english 3. patient who will undergo a primary shoulder arthroplasty 4. patient is over the age of 18 exclusion criteria: 1. patient who has had a previous surgery on the ipsilateral shoulder 2. patient has a known allergy to topical iodine or chlorohexidine gluconate. 3. patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery 4. patient requires a revision procedure for a previous ipsilateral shoulder surgery 5. patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation 6. patient is a pregnant woman

Keywords: shoulder arthroplasty c.acnes cutibacterium acnes irrisept
flupentixol and melitracen tablets in the treatment of emotional disorder

Conditions: Emotional Disorder; Neurologic Disorder

Summary: to evaluate the efficacy and safety of flupentixol melitracen tablets in the treatment of different types of non random emotional disorders

involuntary emotional expression disorder (ieed) is a kind of disorder of emotion control. its main clinical feature is frequent short and violent uncontrollable crying and (or) laughing, which is different from mood disorder and self emotional expression. the mixture of flupentixol and melitracen is used for antidepressant. melitracen is a tricyclic antidepressant, while flupentixol is a neurodepressant in structure, but its dose in deanxit has antidepressant properties. the active components of deanxit are flupentixol dihydrochloride (flupentixol) and melitracen (melitracen). flupentixol is a thiazolyl (thioanthracene) antipsychotic, and melitracen is a tricyclic antidepressant. low dose flupentixol (0.5mg-3mg) has antidepressant and antianxiety effects, while melitracen has antidepressant effect. the mixture of the two components is used to treat mild to moderate mental disorders. the purpose of this study was to evaluate the efficacy and safety of flupentixol melitracen tablets in the treatment of different types of non random emotional disorders.

Eligibility criteria:
inclusion criteria: 1. men and women aged 18-70; 2. patients with nervous system diseases (such as stroke, amyotrophic lateral sclerosis, brain trauma, multiple sclerosis, alzheimer's disease, etc.) accompanied by non random emotional expression disorder; 3. the informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study; 4. the subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures. exclusion criteria: 1. patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases; 2. patients in critical condition or dying can not participate in this study; 3. pregnant or lactating women; 4. substance abuse patients; 5. allergic to deanxit; 6. mental disorder; coma; 7. untreated angle closure glaucoma; 8. in the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia; 9. monoamine oxidase inhibitors were used; 10. participated in any other studies involving studies or post marketing drugs within 30 days prior to screening; 11. according to the judgment of the researcher, there are other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risks associated with participating in the trial or using the research products, or may affect the interpretation of the research results, which may make the subjects unsuitable for participating in the trial; 12. inability and / or unwillingness to understand and / or comply with the protocol.
the efficacy and safety study of dabigatran and warfarin to non-valvular atrial fibrillation patients

Conditions: Atrial Fibrillation

Summary: the purpose of this trial is to demonstrate the efficacy and safety of dabigatran etexilate and different intensity warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of atrial fibrillation 2. echocardiography confirmed a non-valvular heart disease 3. age≥60 years exclusion criteria: 1. unable to cooperate with doctors 2. cha2ds2-vasc\<2 3. life expectancy of less than 1 year 4. rheumatic heart disease or dilated cardiomyopathy 5. history of artificial valve replacement surgery 6. infectious endocarditis 7. stroke or transient ischemic attack(tia) within the last 6 months 8. previous history of intracranial hemorrhage, gastrointestinal, respiratory or urogenital bleeding 9. previous intolerance/allergy to warfarin or dabigatran etexilate 10. blood pressure greater than 180/110 mmhg 11. chronic liver dysfunction, alanine aminotransferase above the normal reference value of the upper limit 3 times 12. chronic renal failure, serum creatinine clearance rate (ccr) less than 30 ml / min 13. patient was receiving antiplatelet or anticoagulant therapy due to other reasons

Keywords: atrial fibrillation dabigatran warfarin anticoagulation elderly
ct findings in surgically treated focal pancreatic disease- a retrospective study

Conditions: Autoimmune Pancreatitis

Summary: to retrospectively investigate ct imaging features of autoimmune and chronic pancreatitis (aip and cp) mimicking pancreatic ductal adenocarcinoma in surgically resected patients.


Eligibility criteria:
inclusion criteria: * definite diagnosis of autoimmune pancreatits or adenocarcinoma exclusion criteria: * no surgery

Keywords: autoimmune pancreatitis pancreatic ductal adenocarcinoma radiology
a study of arry-438162 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug arry-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. approximately 200 patients from the us, argentina, brazil, hungary, peru, poland and romania will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * diagnosis of rheumatoid arthritis, based on the american college of rheumatology (acr) 1987 revised criteria, prior to first dose of study drug. * patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study. * patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study. * no prior use of biological agents for the treatment of rheumatoid arthritis. * additional criteria exist. key exclusion criteria: * diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures. * a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis. * additional criteria exist.
comparison of pharmacokinetics of and effect on systemic vegf levels in age related macular degeneration patients

Conditions: Age Related Macular Degeneration

Summary: to demonstrate the effects of lucentis (ranibizumab), avastin ( bevacizumab), and eylea ( aflibercept) on the levels of naturally occurring vascular endothelial growth factor (vegf) in the systemic circulation of age related macular degeneration patients currently treated with these medications.

to determine plasma levels of vegf and serum pharmacokinetic (pk) levels after varying lengths of time following intravitreal injection with avastin, lucentis, or eylea in exudative macular degeneration. patients will be tested while following a normal course of treatment in our institute. all screenings and testing will be conducted in three study visits.

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent for participation in this study. 2. adults ≥ 50 years of age with exudative macular degeneration treated with avastin, lucentis, or eylea in previously determined time intervals exclusive to a single anti-vegf treatment type for not than three months. 3. control group: age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled. 4. provide signed informed consent. exclusion criteria: 1. uncontrolled blood pressure (defined as systolic \> 160mm hg or diastolic \> 95mm hg while patient is sitting) 2. uncontrolled diabetes mellitus defined by hemoglobin a1c (hba1c \> 12% at screening) 3. concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-vegf medications. 4. previous administration of systemic anti-angiogenic medications within 3 months 5. participation in a simultaneous medical investigation or trial. 6. treatment within 2 months with anti-vegf agent in the fellow eye or anticipated need for further treatment during the study. 7. patients with any cancer diagnosis in remission for less than five years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed. 8. female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms. 9. patients who have significant wound healing during the trial. 10. patients with a history of vitrectomy in the study eye. 11. patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.
mid-infrared spectroscopy as a real time diagnostic tool for chronic endometritis

Conditions: Endometritis; IVF

Summary: the investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected chronic endometritis (ce) condition. furthermore, the investigator propose to develop a discrimination model between the ce and inflammatory ce types using the measured spectroscopic data from freshly excised biopsies.

it is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. in this research, the investigator intent to show that the mid infrared atr (assisted reproductive treatment) spectroscopy method will provide the physician with sufficient information about the ce inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings. * patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (d\&c), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion. * age 18 and over. exclusion criteria: * pregnant women, minors and lack of judgment women will not included * at the request of the examined woman
a study of clr325 in chronic stable heart failure patients.

Conditions: Chronic Stable Heart Failure

Summary: the purpose of this study was to determine the safety and tolerability of clr325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.


Eligibility criteria:
key inclusion criteria: * male and female patients \>18 years of age * body weight between 50 kg and 140 kg * cardiac ejection fraction of ≤ 45% assessed within the last 6 months * for pa catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization * in the opinion of the investigator, heart failure patients who do not require a change in their dose of acetylcholinesterase (ace), angiotensin receptor blocker (arb), β-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 h after randomization. * at baseline, vital signs (systolic and diastolic blood pressure and pulse rate) assessment in the supine position after the subject has rested for at least five minutes. key exclusion criteria: * impaired renal function as indicated by clinically significant abnormal creatinine values (estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 calculated using the modification of diet in renal disease study (mdrd) equation) * history of chronic hepatitis of any non-cardiac etiology * history of any active or clinically significant cardiac tachyarrhythmia (such as recurrent atrial fibrillation with rapid ventricular response within the last year) and patients with chronic atrial fibrillation with a pulse rate ≤ 100 bpm * patients who received an i.v. infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 h prior to randomization * patients with any significant change in their dose of their ace, arb, mineralocorticoid receptor antagonist, diuretic, or β-blocker within the last 12 h * patients with known significant valvular heart diseases indicated by the following: * severe aortic stenosis (aortic valve area \ 50 mm hg as determined by echocardiography) * severe mitral stenosis * history of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria * for echocardiography-based cohorts only, patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days * for pa catheter cohorts, patients with a pulmonary capillary wedge pressure of \<10 mm hg at baseline. for echocardiographic cohorts, patients with a lateral e/e' ratio of \< 7 on their baseline echocardiogram. for patients in whom a lateral e/e' ratio cannot be determined (e.g., patients in atrial fibrillation), a central venous pressure of \< 5 mm hg on baseline echocardiogram as determined by inferior vena cava criteria.

Keywords: apelin clr325 chronic heart failure
continuous glucose monitoring (cgm) in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to examine the effect cgm (continuous glucose monitoring) has on subjects with type 2 diabetes. it is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes mellitus * have an hgba1c value ≥ 7% and ≤17%. * are on basal insulin, with or without oral agents * are not on basal bolus insulin therapy. * have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional. * have no known allergy to medical tape or sensors. * are capable of and willing to test their blood glucose (bg) on an average of 4 times per day. * are willing to not use acetaminophen while enrolled in the study. * are willing not to undergo a mri procedure while wearing the cgm sensor. * are willing and capable of performing self insertions of the device sensor. * women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study. * women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study. * can understand and speak english fluently. exclusion criteria * have been on pump therapy in the 6 months prior to enrollment in the study. * are receiving basal- bolus insulin therapy * are taking any medication that is not approved to be taken with insulin. * are pregnant or have intentions of becoming pregnant during the duration of the study. * have any skin condition that would inhibit the proper wearing of the cgm sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc. * have a hematocrit ≤30% or ≥55% * are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study. * are employed by any company that manufactures or is developing a cgm device. * are deemed incapable of participating in the study by the primary investigator for any reason.