Kornimate/medical-research-clean huggingface dataset:
dose escalation and efficacy trial of gvax® prostate cancer vaccine

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of gvax® prostate cancer vaccine in order to determine a maximum tolerated dose.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma of the prostate * metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy * detectable metastases * ecog performance status of 0 or 1 exclusion criteria: * transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer * significant cancer related pain * prior gene therapy, chemotherapy, or immunotherapy

Keywords: prostate cancer advanced prostate cancer metastatic hormone-refractory gvax vaccine allogeneic cells
brief therapies for problem gambling substance abusers

Conditions: Gambling

Summary: this project evaluates the efficacy of brief interventions for individuals seeking treatment for substance use disorders who also have gambling problems. in total, 220 problem gambling substance abusers will be randomized to one of three conditions: (a) a control condition consisting of 10 minutes of psychoeducation about gambling, (b) 10 minutes of brief advice about problem gambling and how to reduce it, or (c) four session of motivational and cognitive-behavioral therapy. gambling, substance use and psychosocial problems will be assessed using standardized instruments at pre-treatment, month 2, 5, 8, 12, 16, 20 and 24-month follow-up evaluations.


Eligibility criteria:
inclusion criteria: * age \> 18 years * current (past-year) dsm-iv criteria for alcohol, cocaine, opioid or marijuana abuse or dependence * score \>3 on the past-two month sogs * report an average of \>2 gambling days per month for the past 2 months; (e) spent an average of \>$50/month on gambling in the past 2 months * english speaking * sign informed consent. exclusion criteria: * have uncontrolled major psychiatric disorders other than substance use that require inpatient hospitalization (e.g., active bipolar disorder, psychosis, suicidality) * desire specific gambling treatment or are currently receiving treatment for gambling * have severe cognitive impairment * read below 5th grade level * plan to relocate \>100 miles or are likely to be incarcerated

Keywords: gambling brief therapies substance abuse
evaluation of arginine in periodontal and cardiovascular disease

Conditions: Metabolic Disorder; Arginine; Hyperaminoaciduria

Summary: asymmetric dimethylarginine (adma) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and coronary heart disease (chd). the investigators compared the impact of gingival health, periodontitis (cp), chd or of both diseases (cp+chd) on saliva and serum adma levels.

the aim of this study was to evaluate a possible association between both saliva and serum adma levels in patients with cp and with chd and if the serum adma levels are mediated by serum crp.

Eligibility criteria:
inclusion criteria: * presence of at least 16 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
study of lybrel in relation to venous thromboembolism

Conditions: Venous Thrombosis; Pulmonary Embolism; Sinus Thrombosis, Intracranial

Summary: lybrel® is an oral contraceptive that delivers low doses of levonorgestrel and ethinyl estradiol (90 μg/20 μg). lybrel is taken on a continuous basis without a placebo or pill-free interval to inhibit menstrual cycle bleeding by delivering a steady level of the 2 hormones for as long as the drug is used. lybrel was marketed in the us in july of 2007. the objective of this database case-control study is to estimate the risk of idiopathic vte (deep vein thrombosis and pulmonary embolism) in current users of lybrel (ethinyl estradiol 20ug/levonorgestrel 90ug) compared to current users of other oral contraceptives containing 20μg of ethinyl estradiol.

the base population consists of all currently available data on current users (15-49 years old) of lybrel and other oral contraceptives (oc) containing 20 µg ethinyl estradiol in the pharmetrics/ims and marketscan databases. from among the base population, the databases are then searched for any diagnosis of deep vein thrombosis (dvt), pulmonary embolism (pe), or cerebral venous sinus thrombosis (cvst) \[referred to collectively as venous thromboembolism or vte\] that occurred after receipt of lybrel or other oral contraceptives containing 20 µg ethinyl estradiol. the intent is to include newly diagnosed cases of vte.

Eligibility criteria:
inclusion criteria: * new users of the study drugs (i.e., lybrel and the comparison ocs) exclusion criteria: * no specific exclusion criteria for the base study cohort.

Keywords: lybrel levonorgestrel ethinyl estradiol venus thromboembolism (vte) oral contraceptives (oc) safety database study case-control study
kinematic analysis: posterior stabilized, fixed bearing total knee arthroplasty with attune knee system

Conditions: Total Knee Arthroplasty; Osteoarthritis

Summary: a better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (tkas) and to help design a prosthesis that most closely approximates the normal knee. specifically, posterior stabilizing (ps) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. the depuy synthes joint reconstruction's attune ps fixed bearing (fb) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. to understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. this pilot study will analyze 5 subjects with the attune ps fb 3 months post-operatively using the university of tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend. since this is a pilot study, there is no hypothesis.


Eligibility criteria:
inclusion criteria: * at least three (3) months post-operative with no other surgical procedures conducted within the past six months * between 30-80 years of age * body weight of less than 280 lbs * must be between 160cm (5'3) and 193cm (6'4) tall * body mass index (bmi) \>18.5 and \<35 * judged clinically successful with a knee society score (kss) of greater than 80 * have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain * must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (dkb), all without assistance * will have a depuy attune ps tka * must be willing to sign the informed consent (ic) and hipaa forms to participate in the study exclusion criteria: - pregnant or potentially pregnant females will be excluded from the study
the association between residual neuromuscular block risk prediction score and the train-of-four ratio

Conditions: Muscle Relaxants

Summary: evaluate the degree of association, and the predictive accuracy of the reps (as a predictive tool) compared with the tofr as a quantitative assessment tool for (rnmb) in surgical patients in the early postoperative phase. the tofr will be measured at 0, 15, 30, 45, and 60 min after extubation.


Eligibility criteria:
inclusion criteria: 1. age group 18-65 years old 2. both genders 3. patients with american society of anesthesiologist physical status classification of 1 or 2. exclusion criteria: 1. patients who are less than 18 years old or more than 65 years old. 2. patients with planned scheduled recovery in the intensive care unit or if more than 10 minutes had elapsed since tracheal extubation until nmb monitoring at the pacu. 3. patients on medications that interfere with muscle activity. 4. known allergy to neuromuscular blocking agents. 5. pregnancy or suspected pregnancy. 6. neuro-muscular diseases. 7. patients refusing to participate in the study.
0.075% capsaicin lotion for the treatment of painful diabetic neuropathy

Conditions: Peripheral Diabetic Neuropathy

Summary: to study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with pdn compared with placebo lotion as a randomized, double- blind, crossover, placebo-controlled trial

neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. the most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy. topical capsaicin formulations are widely used to manage pain. low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s. we study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with pdn compared with placebo lotion as a randomized, double- blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. all participants are provided both 0.075% capsaicin lotion and placebo lotion. each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. we keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.

Eligibility criteria:
inclusion criteria: 1. dm type 2 over 1 year 2. clinical presentation of peripheral sensory such as burning pain 3. dn4 score from 4 points 4. good consciousness to tell their score with informed consent agreement 5. no adding dosage of previous pain control medications at least 4 weeks 6. hba1c 6.5-9.0% exclusion criteria: 1. improper application site of skin for topical drugs such as abrasion wound. 2. allergic history of capsaicin 3. no intention to join the study with any reasons 4. other previous medications used that effect to peripheral neuropathy such as carboplatin, cisplatin, colchicine, dapsone, etoposide, ethambutol, indomethacin, isoniazid, lithium, metronidazole, phenytoin, pyridoxine, statins, stavudine (d4t) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, hypothyroidism

Keywords: capsaicin neuropathic pain diabetic neuropathy topical lotion
effect of wet cupping versus moderate intensity aerobic exercise on inflammatory markers in diabetic patients

Conditions: Diabetes

Summary: among all pro-inflammatory biomarkers, tnf-α first recognized to be involved in the pathenogenesis of insulin resistance, and glucose-related abnormalities that link to t2dm. tnf-α plays a vital role in the overall pathophysiology of insulin resistance especially in males with greater body mass index as compared to that in the females this trial aims to investigate the effect of wet cupping therapy versus moderate intensity aerobic exercise on inflammatory markers in diabetic patients

cupping therapy is a traditional treatment used to create suction on the skin over a painful area or acupuncture point using a bamboo or glass cup. aerobic exercise (also known as endurance activities, cardio, or cardio-respiratory exercise) is physical exercise of low to high intensity that depends primarily on the aerobic energy-generating process. chronic inflammation, including elevated levels of interleukin 6 (il-6), is associated with diabetes, cardiovascular disease, and chronic kidney disease, as well as related diseases such as nonalcoholic hepatosteatosis. amongst other triggers, elevated il-6 levels may arise due to excess adipose tissue and can cause, for example, aberrant glucose metabolism leading to diabetes and other manifestations of the ensuing glucotoxicity in many tissues and organs, including the vasculature and other parts of the heart and the kidneys, as well as in the liver. the purpose of this study was to investigate the effect of wet cupping therapy versus moderate-intensity aerobic exercise on inflammatory markers in diabetic patients.

Eligibility criteria:
inclusion criteria: * had diabetes more than 10 years ago * body mass index of 25 to 29.9 kg/m2 exclusion criteria: * hepatic diseases, cancer patients, renal failure patients, orthopedic problems or fractures of extremities, hypertensive patients, and neurological problems

Keywords: diabetes, cupping, aerobic excercise
laparoscopic preventive prerectal mesh

Conditions: Urogenital Prolapse

Summary: urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. posterior vaginal wall prolapse is present in only 50% of cases. surgery is an option for women with troublesome prolapse. a woman's lifetime risk of undergoing surgery for pelvic organ prolapse (pop) surgery by the age of 80 is around 19%. laparoscopic sacrocolpopexy (ls) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (prospere study). based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%). the benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 ls with double-mesh (anterior \& posterior, dm) to 32 ls with a single anterior mesh (sam): posterior recurrence rates were respectively 5.9 vs. 31.3% (p\<0,01), and total recurrence rates 16.2 vs. 43.8% (p\<0.01). however, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since). on the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (robolaps study, unpublished data). the rate of de-novo obstructed defecation after ls with prerectal mesh is reported up to 25%. it could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.


Eligibility criteria:
inclusion criteria: * women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (ba and/or c points ≥ - 1 cm using the pop-q system), * without significant posterior vaginal wall prolapse (bp \< -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free), exclusion criteria: * previous surgical repair for pelvic organ prolapse * any associated prolapse requiring any non-authorized additional surgical repair (authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.) * wish for future pregnancy * lack of health insurance * woman not reading french or unable to consent * woman under law protection

Keywords: urogenital prolapse laparoscopic sacropexy mesh medico-economic study
using the visualization for lifestyle change in patients at risk of cardiovascular diseases

Conditions: Cardiovascular Diseases; Coronary Artery Disease; Heart Diseases; Coronary Heart Disease; Visual Analytics; Continuous Glucose Monitoring; CGM; Lifestyle; Behaviour Change

Summary: in the framework of phd research, the investigators will present a visualization of estimation of cvds risk and the possibility of monitoring blood glucose levels in real-time. based on the results, the investigators will assess the association of these with lifestyle change. the findings highlight the need for sufficiently reliable and high-quality evaluations of visualizations, technologies or applications used in the family medicine.

the investigators reviewed the existing literature and found little research on the use of continuous glucose monitoring (cgm) and visualization of score2 prognostic model in healthy populations and how they can influence lifestyle change. the investigators will conduct a randomised control trial with 3 intervention groups and 1 control gropu. the investigators also found that primary care nurses are still using paper-based methods to calculate cvds by using colour-coded charts. therefore, the investigators will use the visual tool of the score2 scale to identify possible increased participants motivation using visualization. the investigators will also confirm or refute lifestyle change by calculating biological age.

Eligibility criteria:
inclusion criteria: * individuals ages more than 40 years * without serious disease progression * at least one risk factor for cvds exclusion criteria: * individuals younger than 40 years * with serious disease progression * without risk factor for cvds
scope analytic treatment interruption protocol

Conditions: HIV/AIDS

Summary: the goal of this study is to understand the interaction between hiv and the host at the earliest stages when hiv medications are paused. volunteers with hiv will interrupt antiretroviral therapy (art) and then have intensive studies preformed two to three times per week. most will resume therapy within three weeks, even if the virus does not rebound during this time.

in this study, people living with hiv will undergo intensive sampling prior to and following an interruption of their antiretroviral therapy (art). individuals will be asked to resume art once the virus is detectable, or after approximately three weeks if the virus remains undetectable. individuals who were able to control their virus before art ("controllers") will be able to participate in an extended treatment interruption and have less restrictive art restart criteria. the overall goal of the study is to characterize the interaction between the host and the virus at the earliest stages of virus replication and to identify predictors of rebound before virus becomes detectable.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * age \>= 18 * documented hiv infection * antiretroviral therapy for at least 12 months * screening plasma hiv rna levels below level of detection (\< 40-75 copies/ml), and all available determinations in past 12 months also below level of detection (blips allowed) * screening cd4+ t-cell count \>350 cells/ul * if of childbearing potential, willing to use two methods of contraception * willing to receive counseling regarding hiv transmission risk mitigation exclusion criteria: * pregnant or plans to become pregnant during the course of the study * active hepatitis b, defined as (1) positive sag or (2) positive cab with negative sab and positive hbv dna * active hepatitis c, defined as positive hep c ab with positive hcv rna * use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen * significant cardiovascular or cerebrovascular disease * recent or prior (within past 5 years) malignancy * severe kidney disease (crcl \< 50 ml/min via cockroft-gault method) * severe hepatic impairment (child-pugh class c) or unstable liver disease * concurrent treatment with immunomodulatory drugs * unable or unwilling to use barrier protection or pre-exposure prophylaxis (prep) to prevent hiv transmission with sexual partners not known to be hiv-infected

Keywords: hiv hiv/aids antiretroviral therapy hiv reservoir biomarkers
on-pump versus off-pump coronary artery bypass grafting , short term outcomes , sohag experience

Conditions: Coronary Artery Disease

Summary: coronary artery disease (cad) and its sequlae, such as myocardial infarction, arrhythmia and heart failure, are among the leading causes of death around the world . the durable role of coronary artery bypass grafting (cabg) in the treatment of cad has long been shown. coronary artery bypass grafting (cabg) is a commonly performed surgical procedure for patients with coronary artery disease (cad), cabg can be performed using either the on-pump or off-pump technique, each with its own advantages and limitations. on-pump cabg involves the use of cpb which as agold standard for surgical coronary revascularization has led toexcellent results in mortality and complications. on-pump cabg allows the surgeon to temporarily stop the heart and provide perfusion and oxygenation to the body. this technique provides a bloodless and motionless operative field, allowing for precise graft anastomosis. however, the use of cpb is associated with deleterious effects as systemic inflammatory response, hemodilution, and organ dysfunction as dysrhythmia and neurocognitive problems. these factors may adversely affect patients lives specially those with impaired ef, who already have compromised cardiovascular function. another technique for cabg is on-pump beating heart cabg (onbh-cabg) surgery that is relatively novel hybrid approach to coronary artery grafting which aims to stabilize hemodynamic parameters during the operative period. this has specific benefits such as reduced preload alongside the afterload which decreases the oxygen demand of the myocardial tissue


Eligibility criteria:
inclusion criteria: * fair and impaired ef exclusion criteria: * malignancy * copd * renal failure on dialysis
intralesional vitamin d in alopecia areata

Conditions: Alopecia Areata

Summary: to evaluate the efficacy and safety of intralesional injection of vitamin d3 versus intralesional injection of corticosteroids in treatment of alopecia areata. this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, faculty of medicine, alexandria university, egypt. the patients will be randomly assigned into two groups (a and b), each group contains 20 patients. patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin d (an aqueous preparation of cholecalciferol (devarol® ampoule 200,000 iu/2 ml, memphis, egypt) (2.5 mg/ml) every 4 weeks for 3 sessions. the maximum total amount of vitamin d3 injected into a patient in 1 session will be 5 mg injection will be preceded by topical anaesthesia under occlusion for 30 minutes.


Eligibility criteria:
inclusion criteria: site: scalp. extent: localized alopecia areata (less than 50% scalp involvement). exclusion criteria: 1. other skin diseases affecting the scalp 2. pregnant or lactating women. 3. bleeding or coagulation disorders 4. immunocompromised patients. 5. known hypersensitivity to vitamin d3. 6. patients who received systemic or topical treatment for alopecia areata in the last month. 7. patients taking vitamin d supplements in the last 6 months. 8. patients treated with topical vitamin d analogues. 9. patients with diseases known to alter vitamin d level as autoimmune diseases, liver or renal diseases. 10. obesity (defined as body mass index ≥ 25).