Kornimate/medical-research-clean huggingface dataset:
naltrexone for prolonged grief disorder

Conditions: Naltrexone HCl 50 MG Oral Tablet; Placebo

Summary: this is a study to see how effective oral naltrexone is as treatment for prolonged grief disorder (pgd). participants will take their assigned medication for 8 weeks, with monthly visits to assess symptom severity, social connectedness, and adverse reactions.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * lives within a reasonable distance from nyph for convenient clinic visits. * can speak, read, and write english proficiently. * meet diagnostic criteria for pgd based on the dsm guidelines * if a female patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while she is taking the study drug. female patients who are planning to use oral hormonal contraception during this time must have initiated it at least 2 months prior to the baseline visit. * if a male patient, must agree to use a method of contraception and be willing and able to continue contraception during the first 8 weeks of the study while he is taking the study drug. exclusion criteria: • having recently started taking/prescribed medications for any psychiatric illness (e.g. ssris for mdd) within the past 3 months; participants who have been taking this medication for longer than 3 months can be included. * having recently started psychotherapy for any psychiatric illness within the past 3 months; participants who have been receiving psychotherapy for longer than 3 months can be included. * prior history of recently active (e.g. within the past 3 months) opioid dependence. * current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including opioid antagonists for alcohol or opioid dependence, all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). * possible future use of opioids during the study (e.g. for surgery). * current use of leflunomide (arava), droperidol (droleptan), diazepam (valium), thioridazine (mellaril, novoridazine, thioril), or any other clinically relevant medication that has potential to cause liver injury with concurrent use of naltrexone. * currently pregnant, lactating, or planning to become pregnant during the study. * active hepatitis or liver disease. * alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels more than one standard deviation (sd) above the upper limit of normal on initial laboratory examination. screen positive for active suicidal thoughts or behaviors.
safety study of dengushield in healthy adults

Conditions: Phase 1; Dengue

Summary: this phase 1 study to evaluate the safety of a single dose of dengushield (dengue monoclonal antibody) in healthy adults.

this phase 1 study will evaluate the safety and tolerability of a single dose of dengushield (dengue monoclonal antibody) in healthy adults in a dose-escalating study design. in addition, pharmacokinetics will also be studied.

Eligibility criteria:
inclusion criteria: 1. healthy adults aged 18-45 years, men, or women. 2. negative dengue ns1 at screening indicating no current dengue infection 3. seronegative for dengue igg 4. participants who are willing to comply with the requirements of the study protocol and attend scheduled visit. 5. participants who give written informed consent. 6. participants having laboratory parameters within normal range 7. participants with body mass index (bmi) between 18 to 30 (both inclusive) 8. satisfactory baseline medical assessment as assessed by physical examination and normal laboratory values or minor variations that is acceptable for study entry. exclusion criteria: 1. presence of acute infection in the preceding 14 days or presence of a temperature ≥ 38.0°c, or acute symptoms of infection greater than of "mild" severity on the scheduled date of first dosing 2. history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders. 3. evidence of any other significant active haematological disease, or having donated \> 450 ml of blood within the past three months. 4. evidence or history of substance abuse including alcohol, or previous substance abuse within the last year. 5. participation or planned participation in a study involving the administration of an investigational compound within the past one month or during this study period. 6. planned administration of any vaccine not foreseen by the study protocol 4 weeks before and after dosing except for influenza vaccination. 7. receipt of immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period. 8. laboratory confirmed infection with hepatitis b virus (hbsag positive), hepatitis c virus (anti-hcv positive) or human immunodeficiency virus (hiv positive) at screening. 9. history of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (mild non-medication allergies allowed). 10. known bleeding disorders. 11. women who are pregnant, breast-feeding, or considering becoming pregnant. 12. any condition that, in the opinion of the investigator, would complicate or compromise the study or well-being of the participant.

Keywords: dengue
topic cervical anesthesia plus paracervical blockade for pain control during endouterine manual aspiration

Conditions: Pain; Abortion, Spontaneous

Summary: to compare the effectiveness of lidocaine gel plus paracervical blockade vs. lidocaine gel alone in the management of pain during endouterine manual aspiration.


Eligibility criteria:
inclusion criteria: * need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding). exclusion criteria: * allergy to lidocain

Keywords: endouterine manual aspiration paracervical blockade lidocaine gel
effects of tanzberger versus pelvic floor muscle exercises on urinary incontinence

Conditions: Urinary Incontinence; Menopause

Summary: randomized clinical trial (rct) will be conducted to compare the effects of tanzberger exercises and pelvic floor muscle training on urinary incontinence and quality of life in post_menopausal females suffering from urine incontinence in which data will be collected from razahat medical centre, lahore via international consultation on incontinence questionnaire-urinary incontinence-short form score (iciq-ui-sf) and incontinence quality of life (iqol) questionnaire. sample size of 34 patients will be taken. non_probability convenient sampling will be used. a written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the pfms group or tanzberger exercise group. treatment will be given three times a week. international consultation on incontinence questionnaire, urinary incontinence-short form questionnaire and incontinence quality of life will be used to measure quality of life. all participants in both groups will be evaluated before and after the treatment programs. total duration of study will be six months. data will be analyzed by using spss 21

urinary incontinence is defined by the international continence society (ics) as the involuntary loss of urine through urethra which is distressing and disabling condition mainly affecting the social and psychological well-being of an individual. due to the embarrassing nature of incontinence, it is both underreported and under diagnosed. it affects women's quality of life. tanzberger technique using swiss ball strengthen levator ani muscles which play role in closing urethra. pelvic floor muscle exercises are safe and efficient treatment option to treat urinary incontinence and improves quality of life. the significance of this study is, pmfs training and tanzberger exercises will be executed in comparison to treat post-menopausal women who are facing with unhygienic and social embarrassing health disorder of urinary incontinence.

Eligibility criteria:
inclusion criteria: * age between 45 to 60 years. * postmenopausal females * diagnosed patients of urinary incontinence exclusion criteria: * delivery with any complication. * females have any history of diabetes, hypertension, neurological, or any chronic illness. * any pelvic or abdominal surgery * disc herniation or spine fracture.

Keywords: pelvic floor muscle training tanzberger exercise urine incontinence
buprenorphine naltrexone-p1 a-cocaine

Conditions: Cocaine-related Disorders

Summary: the purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. this study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.


Eligibility criteria:
inclusion criteria: * provide written informed consent * be male/female between the ages of 18-55 * be in good physical and mental health as determined by interview and physical exam * have a body mass index between 18 and 30, inclusive * have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo * have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone * be able to comply with protocol requirements * if female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo exclusion criteria: * please contact site for more information
prospective breast cancer biospecimen collection

Conditions: Breast Cancer; Invasive Breast Cancer; Carcinoma in Situ of the Breast

Summary: tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. a one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. follow up will only consist of chart review to determine date of recurrence, metastases, and/or death


Eligibility criteria:
inclusion criteria: * adults \>18 years old at time of consent * subject must be capable to giving informed consent or have an acceptable surrogate capable of giving consent on the subject behalf. * patients with carcinoma in situ or invasive breast cancer * patient must be undergoing one of the following: * definitive surgical tumor resection for breast cancer or * placement of a vascular access device as a prelude to neoadjuvant therapy for breast cancer or * neurosurgical resection of a brain metastasis from primary breast cancer. exclusion criteria: * \<18 years old * not able to give informed consent and does not have acceptable surrogate capable to giving informed consent. * active drug/alcohol dependence or abuse history
lpd+α-ketoacids on autophagy and improving muscle wasting in ckd

Conditions: Muscular Atrophy

Summary: to investigate the effects of different dietary regimens on muscle wasting, insulin/igf-1 resistance. further, to explore whether lpd+ka decrease the activation of autophagy associate with insulin/igf-1 pathway.

1. dietary assessment: the composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with dieta software. 2. biochemical data: blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, hba1c, serum igf-1, crp, will be measured. homeostatic model assessment score (homa-ir) was recorded. 3. skeletal muscle assessment: the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. body weight, height, body mass index, skeletal muscle mass will be measured by body composition analyzer. quadriceps strength will be assessed with a seated leg press exercise instrument (keiser sport, fresno, ca, usa) using the five repetition maximum technique. knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (university ofnottingham medical college, nottingham, uk). fatigability will be assessed with the same bilateral leg press exercise used in strength testing.

Eligibility criteria:
inclusion criteria: * patients agree to participate in this study; age≥18 years and\ 15 ml/min (three monthly consecutive measurements)；at least 6 months of follow up at our clinic before recruitment and haven't received any diet intervention. exclusion criteria: * pregnant patients; diabetes; heart or liver failure; a recent myocardial infarction (in the last 12 months); long term immobilization; chronic respiratory failure; cancer; any pharmacological treatment that could modify muscle structure or function such as glucocorticoids or insulin；contraindications of ketosteril, such as hypersensitivity to the active substances or to any of the excipients, hypercalcaemia, disturbed amino acid metabolism to the study protocol.
astigmatism correction with intrastromal arcuate incisions in eyes undergoing cataract surgery with femtosecond laser using the cassini ambient with iris registration (arcuatas)

Conditions: Cataract; Astigmatism

Summary: this is an observational, prospective follow-up post-marketing study of ce marked medical devices aimed at treating astigmatism in patients with cataracts. the main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the catalys femtosecond laser using the cassini ambient equipment with iris registration in cataract surgery.

all patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the catalys laser (johnson \& johnson, usa, ce marked). the calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50d, 55 degrees for 0.75d, 60 degrees for 1.00d and 65 degrees for 1.25d of corneal astigmatism. after the incisions, conventional cataract surgery will be performed using the centurion phacoemulsifier equipment (alcon, usa, with ce marking) in the zcb00 monofocal intraocular lens (iol) implant (johnson \& johnson, usa, with ce marking). all patients will be treated according to standard clinical practice. a preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the cassini ambient equipment (cassini technologies, the netherlands, with ce marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the iolmaster 700 non-contact optical biometer (carl zeiss, germany, ce marked).

Eligibility criteria:
inclusion criteria: 1. patients who are going to undergo cataract surgery. 2. low corneal astigmatism, between 0.50d and 1.25d. exclusion criteria: 1. previous corneal surgery. 2. keratoconus. 3. corneal scars 4. pterygium 5. glaucoma
deep brain stimulation for the treatment of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (dbs)as a treatment option for patients with cognitive, behavioral, and functional disability of alzheimer's disease.

open label pilot study * expected direct benefit on the modulation of neuronal networks. * expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities. up to 10 subjects will be implanted with bilateral dbs systems, participants are expected to be on study for about 23 months. * develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by alzheimer's disease. * enroll up to 10 patients into an open label study to evaluate the safety and efficacy of dbs for alzheimer's disease patients with mild to moderate disability. * determine an initial dbs titration and stimulation settings protocol for use in subsequent controlled trials. * evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments. * determine what domains of cognitive, behavioral and functioning impairment show the greatest response to dbs. * examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone. * evaluate the influence of dbs on physiological and functional changes in cortical and subcortical networks.

Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to the national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria exclusion criteria: * has significant neurological disease, other than alzheimer's disease, e.g., multiple sclerosis, parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas. * evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (dsm-iv criteria).
long-term effects of individualized follow-up with an app for one year

Conditions: Coronary Artery Disease

Summary: the aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-cr.

recently, our research group demonstrated that individualized follow-up with an app for one year post-cardiac rehabilitation (post-cr) significantly improved exercise capacity, exercise habits and self-perceived goal achievement compared to a control group receiving usual care. to prepare for real-world implementation of an app to promote healthy behaviour post-cr, we will investigate the long-term effects (3-5 year post intervention). the aim of this study is to examine the long-term (3-5 year post intervention) effects post individualized follow-up with an app for one year, compared to a control group that received usual care on factors related to healthy behaviour in patients post-cr. we hypothesize that patients allocated to the intervention group post-cr have internalized healthy behaviour and therefore have significantly higher exercise capacity and lower bodyweight compared to the control group, 3-5year post intervention.

Eligibility criteria:
inclusion criteria: * included in the rct of which this study is built on

Keywords: cardiac rehabilitation mhealth mobile phone app lifestyle smartphone
dog hair extract study

Conditions: Potency of Dog Hair Extract

Summary: liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat, cockroach, and nuts, and are used to identify allergies by observing the body's reaction to the introduction of extract underneath the skin. there are a few dog allergen extracts commercially available in the us for allergy testing; however, none of these products are standardized, meaning they are not required to be the same strength. because some extracts are not as potent (strong) as others, it's possible that some patients' allergies are misdiagnosed. typically, the most potent (strong), but safe extract should be used so that allergic patients are correctly diagnosed. the purpose of this study is to compare the safety and potency of an investigational (not approved for use by the united states food and drug administration \[fda\]) dog allergen extract with two commercially available dog extracts, which are of differing potencies.

this study is designed to assess the potency of a modified dog hair and dander extract in comparison with the two commercially available dog hair and dander extracts. this is a pilot study to estimate a target strength of dog extract in order to proceed to further studies.

Eligibility criteria:
inclusion criteria: * patients must sign informed consent before completing any study procedure. * age 18 years and ≤60 years. * dog-sensitized patients as indicated by a mean wheal \> 5 mm with the ap dog extract. * females of child-bearing potential must have a negative pregnancy test the day of skin testing. * patients who are able to understand the information given and be compliant with the protocol. exclusion criteria: * asthma requiring treatment with medications other than beta-2 inhaled agonists and montelukast inhibitors. * patients with a history of asthma or wheezing with an fev1 \<80%. * subjects who have taken an ocular or nasal antihistamine within 5 days prior to the procedures. * patients who have received any desensitization for dog allergen in the past 5 years. * patients with any past or current clinically significant condition that may affect the patient's participation or the outcome of the study to the discretion of the investigator. these include, but are not limited to, anaphylaxis with cardio-respiratory symptoms, chronic urticaria and angioedema unless related to dog exposure, severe atopic dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological, immunological, and endocrine disease. * subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy, immunosuppressive drugs or monoamine oxidase inhibitors. * use of h1 antagonists, tricyclic antidepressants and phenothiazines within 5 days prior to the testing.

Keywords: skin tests dog hair allergy extract
observational real-world evaluation of cost of infections of rheumatoid arthritis (ra) patients on biologics

Conditions: Rheumatoid Arthritis

Summary: to quantify the incremental cost of infections in patients treated with etanercept, adalimumab or infliximab versus abatacept.


Eligibility criteria:
inclusion criteria: * 18 years of age and older; * have a diagnosis of of rheumatoid arthritis (icd-9:714x.xx); * have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment; * are enrolled in a health plan between february 2006 and june 2009 * have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for teh 6 months assessment and 12 months for the 12 months assessment exclusion criteria: * patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded * patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period). * patients on biologics 6 months prior to the biologic index date will also be excluded * patients with diagnosis for other non-ra conditions commonly treated with biologics (ex. crohn's disease) during the 6 month pre-index period.