Kornimate/medical-research-clean huggingface dataset:
green tea extract in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: green tea extract contains ingredients that may slow the growth of certain cancers, as well as prevent the development of new cancers. purpose: phase i trial to study the effectiveness of green tea extract in treating patients with advanced solid tumors that are refractory to standard therapy.

objectives: i. determine the maximum tolerated dose of green tea extract administered daily to adults with solid tumors. ii. determine the safety of chronic daily administration of green tea extract in these patients. iii. investigate the clinical pharmacology of green tea extract in this study. iv. document observed antitumor activity of this treatment. outline: this is a dose escalation study of green tea extract. patients receive green tea extract by mouth daily after meals for 4 weeks. one patient is entered at each dose level. if grade ii toxicities are experienced, then 2 more patients are entered at the same dose level. one patient must complete 4 weeks of therapy and 2 others must complete 2 weeks of therapy with no greater than grade i toxicity before dose escalation proceeds. if at least 2 patients experience dose limiting toxicity at any dose level, the immediately preceding dose level is considered the maximum tolerated dose (mtd). at least 6 patients are studied at the mtd. patients may continue therapy for up to 6 months in the absence of toxicity and disease progression. patients are followed every 4 weeks for the duration of treatment and at least one month after completing treatment. projected accrual: approximately 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: pathologically proven incurable advanced solid tumor refractory to standard therapy or for which no standard therapy exists no known brain metastases patient characteristics: age: 18 and over performance status: zubrod 0-2 or karnofsky 70-100% life expectancy: not specified hematopoietic: wbc at least 4,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl ast less than 1.25 times normal renal: creatinine no greater than 1.5 mg/dl cardiovascular: no significant cardiac disease other: no significant metabolic disorder no significant infection not pregnant or nursing effective contraception must be used by fertile women prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 3 weeks (6 weeks for nitrosourea) since prior chemotherapy and recovered endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy and recovered surgery: not specified

Keywords: unspecified adult solid tumor, protocol specific
discovering the effect of venous insufficiency on nocturia (devine)

Conditions: Edema Leg; Venous Insufficiency of Leg; Nocturia; Bio-Impedance Measurements

Summary: nocturia, or waking during the night to pass urine, is a multifactorial disease. an important cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs. venous insufficiency is an important cause of peripheral edema. the investigators hypothesize that, as a result of the lying position during the night, the accumulated fluid in the lower limbs returns to the systemical circulation leading and is excreted during nighttime. this will lead to a higher voiding frequency during the night. with this trail the investigators wanst to prove the difference in leg edema between healthy volunteers and volunteers with venous insufficiency (type 1 or 2).


Eligibility criteria:
inclusion criteria: * age between 25 years and 60 years * for the volunteers with venous insuffiency: clearly visual venous insufficiency (ceap 1 and 2) * bmi between 24 and 30 exclusion criteria: * volunteers using medication (exception for contraception) * volunteers having comorbidities * pregnant women * women who menstruate on the test date * volunteers with an implanted elektronical device (ipg, pacemaker)
feasibility of a standardized video for patient education and as a decision aid on code status for patients in the emergency department pending admission to the hospital

Conditions: Patient Education

Summary: the researchers hypothesize that patients and their families will be comfortable watching standardized cpr informational videos and that they would recommend that others watch the videos. furthermore, the researchers hypothesize that patients and their families will find the videos helpful in their own end-of-life planning.

the code status video, produced by experts in palliative medicine and end of life care, has been evaluated in a variety of healthcare settings to allow patients to make more informed decisions based on realistic information about resuscitation status. this video could be used as a supplement for clinical discussions and decision making. it is not meant to replace a careful, individualized discussion by the clinician with patients and their families, but appears to be a helpful tool to help educate patients in order for them to be better informed to make complicated decisions about their code status. the emergency department is an ideal setting to evaluate the video because they could improve patient understanding in an environment with inherently limited face-to-face provider time. specific aims 1. to assess the satisfaction of patients and family members who view the video on cardiopulmonary resuscitation. this will be measured through use of a questionnaire asking them to score their comfort with watching the video and how likely they would be to recommend the video to others. 2. to assess if watching the standardized video changes patients' code status. this will be measured as what patients' code status was before and after watching the video.

Eligibility criteria:
inclusion criteria * any patient in the emergency department whose disposition is listed as a full admission to the hospital * provider willingness to have patient watch the video and be available to answer questions after. * age \> 65 * ability to provide consent exclusion criteria * does not speak english * hearing or visually impaired * prisoner or incarcerated * inability to provide consent according to attending physician or study coordinator and legal power of attorney is not present
hemostasis alterations in neurosurgical patients

Conditions: Glioma; Coagulopathy; Acquired Platelet Function Disorder; Thromboelastometry; Surgery

Summary: prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

brain parenchyma express tissue factor and other coagulation factors in high concentrations. in addition, neuro critical patients (ncp) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. it is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. this prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression. this is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. samples will be drawn before and after surgical procedures. multiple statistical comparisons intra and inter groups will be performed.

Eligibility criteria:
inclusion criteria: * patients undergoing elective surgeries: glioma or colon cancer resections. exclusion criteria: * severe bleeding leading to patient's' death. * incomplete tumor resection. * peri operative complications leading to severe bleeding or prolonged icu or hospital stay. * peri operative blood components transfusion. * peri operative transfusion of concentrate coagulation factors. * intake of anti coagulant and / or antiaggregant drugs 7 days before surgery. * history of coagulopathy. * inform consent denied for patients or relatives.

Keywords: bleeding clotting tests neurosurgery clotting time maximum clot firmness kinetics lysis primary hemostasis platelet dysfunction coagulation
fexofenadine use in gastroesophageal reflux symptoms

Conditions: Gastroesophageal Reflux

Summary: the investigators wish to study the effectiveness of fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. the investigators will do this by giving participants both fexofenadine (an h1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. the participants will not know which drug they are getting at a particular time. this will help the investigators better assess the true effectiveness of fexofenadine.

around 18-28% of north american adults have gastroesophageal reflux symptoms once per week. of those patients up to 60% may have an inadequate response to proton pump inhibitors and have persistent symptoms. one possible explanation is that this group of patients has nerve related pain. it is thought that h1 receptor activation may sensitize the gastrointestinal tract and esophagus to pain. h1 blockers such as anti-histamines may play a role in treatment of gastroesophageal reflux symptoms that are refractory to proton pump inhibitors by reducing pain perception. the investigators wish to conduct a randomized control trial to test this hypothesis. the investigators will do this by giving participants both fexofenadine (an h1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. the participants will not know which drug they are getting at a particular time. this will help the investigators better assess the true effectiveness of fexofenadine.

Eligibility criteria:
inclusion criteria: * a minimum 6-month history of heartburn and regurgitation, as their main symptom * experience at least 3-4 days with episodes of heartburn or regurgitation per week * female patients who are postmenopausal or using acceptable methods of birth control. exclusion criteria (selected) * esophageal stricture * primary esophageal motility disorder * systemic sclerosis * active inflammatory bowel disease * zollinger-ellison syndrome * active gastric or duodenal ulcer * active infectious or inflammatory conditions of the small or large intestine * malabsorption syndromes of the intestine * history of gastrointestinal cancer * current active cancer * prior gastric or intestinal surgery * pregnant or breast feeding * other serious psychiatric or medical disease
kinesiology taping technique in post-mastectomy breast cancer related lymphedema

Conditions: Post Mastectomy Lymphedema

Summary: generally, breast cancer related to lymphedema is commonly found in the female population after mastectomy. it has many complications which affects the normal functions of an individual and quality of life. this randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength.

generally, breast cancer related to lymphedema is commonly found in the female population after mastectomy. it has many complications which affects the normal functions of an individual and quality of life. traditional therapies like compression decongestive therapies and kinesiology taping techniques are used for the management of post mastectomy breast cancer related lymphedema.this randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength. total 50 patients with post mastectomy who fulfill the inclusion criteria will be selected after taking consent. the subjects will be allocated into two groups through simple random sampling. subjects ingroup a will be given kinesiology taping technique and exercise therapy whereas; patients in group b will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy). all subjects will be assessed using assessment form, upper limb functional index, dynamometer, pinch meter and tape measure. assessment will be conducted at base line, after 2 \& 4 weeks.

Eligibility criteria:
inclusion criteria: * age 30 to 65 * patient undergoing unilateral modified radical mastectomy * within 1 week post mastectomy * subjects without swelling or with mild swelling exclusion criteria: * active cancer or disease that might lead to swelling * subjects taking anticoagulant therapy * diagnose skin disease and skin allergies * vascular insufficiency * sensory impairments * open wound and scars which have not healed * functional limitations of upper limb before mastectomy e.g. adhesive capsulitis.

Keywords: physiotherapy breast cancer breast carcinoma
comparing the performance of two different daily disposable lenses (miki)

Conditions: Myopia

Summary: the objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each

the study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.

Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. habitually wears soft contact lenses in daily wear, for minimum of 6-months; 5. is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; 6. has an astigmatism of ≤ 1.00 d in subjective refraction; 7. can be fit with study contact lenses with a power between -2.00 and -5.00 ds; 8. demonstrates an acceptable fit with the study lenses; 9. habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study. exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. verbal confirmation at the screening visit is sufficient; 7. is aphakic; 8. has undergone refractive error surgery; 9. is an employee of the centre for ocular research \& education; 10. has participated in the boxer (i.e. ex-mktg-107, phases 1 or 2) or basset (exmktg-113) study; 11. has participated in any clinical trials within a week prior to the study.
testosterone for penile rehabilitation after radical prostatectomy

Conditions: Hypogonadism; Erectile Dysfunction

Summary: the purpose of this study is to determine the effectiveness of testosterone replacement therapy (trt) in men following surgery to remove the prostate in improving erectile function. subjects will be randomized (like flipping a coin) to one of two groups. one group will receive testim® (testosterone gel) 5 g per day plus viagra 25 mg every night and the other will receive placebo-testim® 5 g per day plus viagra 25 mg every night. subjects will begin drug treatment 3 months after the initial screening visit and will take study drug for 3 months only. participation will end at the end of the 6-month visit.

there was only one patient who began treatment with the study drug. after blind was broken, it was noted that he received placebo testim and viagra.

Eligibility criteria:
inclusion criteria: * males, 18 years of age or older, with low testosterone levels. * must have undergone a bilateral nerve sparing radical prostatectomy. * nadir psa (prostate-specific antigen) values should be less than 0.01 ng/ml on two consecutive occasions separated by 4 weeks at the start of treatment. * must give informed consent. * must be willing to complete follow-up visits. exclusion criteria: * testosterone level greater than 300 ng/ dl * hemoglobin level greater than 18 ng/dl. * positive surgical margins or evidence of residual prostate cancer after surgery. * clinically suspected advanced disease or actual evidence of metastatic prostate cancer. * primary gleason grade greater than 3 or secondary gleason grade greater than 4 in the final pathologic specimen will be excluded. * taking nitrates or with contraindications to the use of viagra or androgen therapy will be excluded. * known hypersensitivity to any component of the tablet will be excluded.

Keywords: hormone replacement therapy radical prostatectomy erectile dysfunctions scheduled for removal of prostate gland
case management dyad

Conditions: HIV; Pre-exposure Prophylaxis; Case Management

Summary: the overall goal of this study is to test whether dyadic and focused case management will (1) improve financial wellbeing, (2) improve access to food, (3) increase linkage and retention rates for individuals living with hiv or those taking prep (prep persistence), and (4) increase the proportion of individuals living with hiv who are virally suppressed (viral suppression) when compared to routine ryan white non-medical case management.

the purpose of this research is to test the impact of dyadic, focused case management on financial well-being, access to food, linkage to and retention in care outcomes for individuals living with or vulnerable to hiv. the study population is men who have sex with men (msm) or same-sex attraction, gender-diverse persons, and cis-gender women living with or at increased vulnerability to hiv. the study team will be testing the hypotheses that dyadic case management that is focused on financial wellness, will have better outcomes for folks living with or vulnerable to hiv. analyses will be used to assess the efficacy of the intervention as an emerging practice.

Eligibility criteria:
gap in hiv or prep care access in the past 24 months, defined as a gap greater than 6 months or detectable viral load at least one time in the past 24 months self-reported financial or food insecurity

Keywords: linkage to care viral suppression case management retention in care financial wellbeing food security
the effect of intraperitoneal bupivacaine versus bupivacaine with neostigmine on pain in laparoscopic cholecystectomy

Conditions: Pain, Postoperative

Summary: injection of intraperitoneal bupivacaine revealed an analgesic effect whether injected alone or in combination with other adjuvants, which increase duration of analgesia and decrease the dose of administered bupivacaine thus minimizing its side effects e.g. opioids, corticosteroids and magnesium sulphate. neostigmine, a cholinesterase inhibitor that produces muscarinic receptor-mediated analgesia, increased postoperative analgesia when combined with local anaesthetics. peripheral afferent nerve fibres contain muscarinic receptors, these could be a good target for pain suppression.

the use of neostigmine as adjuvant to intraperitoneal bupivacaine was not previously investigated. in this study the investigators will compare the analgesic effect of bupivacaine alone and bupivacaine in combination with neostigmine when injected intraperitoneal in patients undergoing laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * • american society of anaesthesiologist (asa) i-ii. * age 18 - 60 years. * elective laparoscopic cholecystectomy. * body mass index (bmi) \<35 (kg/m2). exclusion criteria: * • anaphylaxis to local anaesthetics. * anaphylaxis to neostigmine. * american society of anaesthesiologist (asa) iii-iv. * chronic pain diseases. * acute cholecystitis. * psychological or nervous system diseases
use of vagitories based on st. john's wort, tea tree oil and shepherd's purse in the treatment of vaginal inflammation

Conditions: Non Specific Vaginitis

Summary: there are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical picture of vaginitis by patients themselves, but also by healthcare professionals. plant species, st. john's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are well known for there anti-inflammatory, antimicrobial and wound healing activity. this paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of above mentioned plant species, were investigated for their effectiveness on non-specific vaginitis. this was randomized controlled clinical study that included 210 women with diagnosed non-specific vaginitis. patients were divided into two basic groups, women in reproductive stage and postmenopausal stage. three subgroups, containing approximately 30 patients each, received one of three vagitorie formulations for 5 days during which the effects on subjective and objective symptoms were monitored.


Eligibility criteria:
inclusion criteria: * adult women who already had sexual intercourse * diagnosis of non-specific vaginal inflammation by medical examination. exclusion criteria: * microbiologically confirmed bacterial vaginosis, * treatment with antibiotic therapy according to official protocols and guidelines * allergies to one of the plant species included in the vaginal test, * diabetes mellitus, * pregnancy, * lactation, * immunodeficiency disorder, * severe chronic illness, * previous radiotherapy, chemotherapy and biological therapy