Kornimate/medical-research-clean huggingface dataset:
extension of study zpv-200

Conditions: Uterine Fibroids

Summary: the purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered proellex in premenopausal women with uterine fibroids confirmed by ultrasound.


Eligibility criteria:
inclusion criteria: * healthy adult females between 18 and 47 years of age with uterine fibroids confirmed by ultrasound. normal, or abnormal but non-clinically significant, transvaginal ultrasound. history of menstrual events occurring in regular cycles. * agreement not to attempt to become pregnant. * agreement to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours before each visit. * ability to complete a daily subject diary and study procedures in compliance with the protocol. * agrees to use the condoms provided and no other method of birth control (hormonal methods, contraceptive sponge, spermicide or cervical cap) over the course of the study. * has a negative pregnancy test at the screening and baseline visits. an exception for the pregnancy test requirement will be granted for subjects providing verification of surgical sterilization. * a body mass index (bmi) between 18 and 39 inclusive. * is available for all treatment and follow-up visits. * subject is able to insert vaginal suppositories. * subject is willing to exclusively use sanitary napkins (no tampons) during study duration. exclusion criteria: * subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy. * subject is pregnant or lactating or is attempting or expecting to become pregnant during the 7 month study period. * women with abnormally high liver enzymes or liver disease. (alt or ast exceeding 1.5x uln and total bilirubin exceeding 1.5xuln at screening and confirmed on repeat). * received an investigational drug in the 30 days prior to the screening for this study. * women with a history of pcos. * concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dhea or hormonal products for at least 2 weeks prior to screening and during the study. * use of oral contraceptives in the preceding 30 days. use of depo-provera® in the preceding 6 months. * has an iud in place. * women currently using narcotics. * women currently taking cimetidine or spironolactone. * clinically significant abnormal findings on screening examination or any condition, which in the opinion of the investigator, would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study. * participation in study zp-204.
effect of talar mobilization with movement versus acupuncture on knee pain and function in the postmenopausal women

Conditions: Talar Mobilization Acupuncture

Summary: the purpose of this study is to determine the effect of talar mobilization with movement versus acupuncture on knee pain and function in the postmenopausal women

a sample of forty postmenopausal women were selected from department of gynecology and obstetrics, participants were assigned into two groups (group a) postmenopausal women who receive the talar mobilization with movement technique for knee joint , their age raged from 50-60 years (n= 20) and (group b) postmenopausal women who receive acupuncture for knee joint (n= 20), their age ranged from 50-60 years and body mass index (bmi) for both groups were less than 30 kg/m2. all participants were evaluated through measuring knee range of motion by using goniometer and the degree of knee pain by using numeric rating scale and pressure algometer

Eligibility criteria:
inclusion criteria: * ) females patients refered from orthopedic surgeon diagnosed with knee oa (2) their age ranged from 50 _60 years old 3) their bmi less than 30 kg/m2. 5) knee pain in the previous week with an intensity of at least 3 points on a numeric pain rating scale (nprs ) (5) patients limited ankle dorsiflexion rom 6) all patients had 3 points on nps (7) presence of knee pain for at least 3 moonths 8) all patients were given the arabic version of koos questionnaire exclusion criteria: * 1) patients with rheumatoid arthritis 2) their bmi more than 30 kg/m2. 3) unrelated to any traumatic knee event 4) patients with previous tibial fracture 5) patients with ankle instability 6) patients with previous meniscal degeneration 7) patients with hyper laxity 8) patients with neurological disorders
can trajectory nor-epinephrine infiltration reduce blood loss during percutaneous nephrolithotomy (pcnl)?

Conditions: Blood Loss, Surgical

Summary: during pcnl; a few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change \& blood loss is estimated and will compared.

all patients of are positioned in lithotomy position and 6 f open tip ureteral catheter is fixed by cystoscope. then, a pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 gauge (g) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 g chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an amplatz sheath was inserted. nephroscope is used for stones disintegration by pneumatic or laser lithotripter . fragments are washed out or removed by forceps.

Eligibility criteria:
inclusion criteria: * renal stones\>2 cm exclusion criteria: * coagulopathy, congenital anomalies, active urinary tract infections
study of pentasa® for reducing residual systemic immune activation in treated hiv infection

Conditions: HIV-1-infection; Gut Inflammation

Summary: an open label study will be performed on 80 people with hiv infection who are maintained on effective treatment with antiretroviral drugs.

the goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated hiv-1 infection. specifically, the two immediate goals are to examine the safety of pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated hiv-1 infection.

Eligibility criteria:
inclusion criteria: * age at least 18 * on art for at least 1 year during which: viremia \ 500 during that time * cd4 t cell nadir \>350 * last cd4 and t cell test in past 6 months exclusion criteria: * plans to modify antiretroviral therapy in the next 12 weeks for any reason * history of inflammatory bowel disease or irritable bowel disease * chronic active hepatitis b or c * history of autoimmune disease * hypersensitivity to any component of pentasa * clostridium difficile infection * receiving rectally delivered medications * receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or tnf inhibitors) * receiving immunosuppressive steroids * receiving any medications associated with bleeding risk * hemoglobin \< 10.0 g/dl * platelet count less than 100,000/mm3 * white blood cell count \ 15,000 cells/mm3 * symptoms of sexually transmitted infection * antibiotics used in the last 90 days * renal insufficiency with creatinine clearance less than 50 ml/min * elevated transaminases greater than 2.5 times the upper limit of normal * evidence of decompensated cirrhosis, heart failure * pregnant or breastfeeding women
single-center ambispective observational study on the role of magnetic resonance imaging (mri) in the evaluation of patient affected by hepatic metastases of carcinoma of the colorectal cancer (crc).

Conditions: Colorectal Cancer

Summary: this study wants to evaluate the use of mri in the managemente of mcrc with liver only metastases.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * histological diagnosis of colorectal cancer; * presence of liver metastases in the staging exams (chest-abdomen ct with contrast medium or pet-ct with 18-fdg); * at least one measurable liver lesion according to recist 1.1 criteria; * adequate organ and marrow function. exclusion criteria: * age \< 18 years; * inability to undergo mri; * major contraindications to liver surgery; * no written informed consent.
sensorimotor training exercise after lower extremity burns

Conditions: Lower Extremity Burns

Summary: burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. therefore, to guide recovery accurately and facilitate rehabilitation after llbi, multi-factorial assessment is required.

burns to the lower limbs can cause pain, scar tissue contracture, impaired sensation, muscle weakness and postural imbalance are all potential complications of lower limb burn injury (llbi) which negatively influence a person's ability to function normally sensorimotor training is a special form of proprioceptive and balance exercise that was designed for management of patients with chronic musculoskeletal pain syndromes. it is based on the concept that instead of emphasizing the isolated strength of a group of muscles around a joint, we should realize the importance of the central nervous system in regulating movement in order to reach proper firing patterns for maintaining joint stability.

Eligibility criteria:
inclusion criteria: * diagnosis of thermal burn injuries at the lower extremities. * total body surface area burned approximately from 40 to 50%. * patients age: 20 to 50 years. exclusion criteria: * cognitive or mentality dysfunctions. * psychiatric conditions. * fractures. * pregnancy. * cancer. * severe vascular complications.

Keywords: sensorimotor training stability mobility balance burn
hemodynamic assessment apco monitor vs crit line for renal replacement rx

Conditions: Renal Failure; Hemodynamics

Summary: fluid and volume management are a challenging part of critical care and the difficulties increase in the face of renal failure. utilizing the crit-line to monitor blood volume changes in conjunction with arterial pressure cardiac output monitoring may lead to better understanding of the impact fluid removal during dialysis has on hemodynamics.

patients in an icu often require large amounts of iv fluid to maintain adequate cardiac function. in patients with renal failure, the ability to gauge adequacy of circulating blood volume based on urine output is obviously lacking. the fda approved devices called flotrac/vigileo and crit-line are used in this setting to determine adequacy of fluid resuscitation. this study proposes to use the data collected in a retrospective manner to determine if correlation of the various measured parameters can serve as a predictor of hemodynamic status.

Eligibility criteria:
inclusion criteria: * indwelling arterial catheter * require dialysis * cvp in place * use of crit-line and flotrak device exclusion criteria: * aortic regurgitation * use of an intra-aortic balloon pump * weight less than 90 lbs * cardiac arrhythmias

Keywords: hemodynamics
a pumpkin seed, isoflavonoid and cranberry mix in luts/bph

Conditions: Benign Prostatic Hyperplasia

Summary: the aim is to assess the efficacy of a mix of pumpkin seed extract, soy germ isoflavonoids and cranberry (novex®) in the management of mild to moderate luts in bph patients. the patients will be evaluated based on the severity of luts, urological quality of life, and erectile function.

this is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving luts, urological quality of life, and erectile function in bph patients. the compound will be administered orally two tablets daily for 3 months. recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.

Eligibility criteria:
inclusion criteria: * mild to moderate luts due to bph for at least 6 months at the initial visit * no previous therapy or are still symptomatic despite the current use of alpha-blockers exclusion criteria: * international prostate symptom score (ipss) \> 19 * prostate cancer * urethral stenosis
effect of rubus occidentalis extract on plasma glucose levels in subject with prediabetes

Conditions: Prediabetes (Impaired Fasting Glucose and/or Impaired Glucose Tolerance)

Summary: the purpose of this study is to determine whether rubus occidentalis extract could improve fasting or postprandial serum glucose levels, and related metabolic markers among patients with prediabetes (impaired fasting glucose and/or impaired glucose tolerance).


Eligibility criteria:
inclusion criteria: * 19 years of age or older * prediabetes (fasting plasma glucose 100-125mg/dl, and/or post 75g ogtt plasma glucose 140-199mg/dl) exclusion criteria: * pregnant women * taking anti-hyperglycemic agents within 3 months at the time of enrollment * history of heart failure, myocardial infarction, cerebral infarction * uncontrolled hypertension (systolic bp \> 160mmhg, or diastolic bp \> 100mmhg) * serum triglyceride level \> 500mg/dl * kidney dysfunction (serum creatinine \> 30% of upper normal limits) * hepatic dysfunction (ast, alt \> 3 times of upper normal limits) * taking systemic glucocorticoids within 1 month
dulaglutide versus liraglutide in obese type 2 diabetic adolescents using metformin

Conditions: Type 2 Diabetes Treated With Insulin; Obesity; Adolescent Obesity

Summary: to compare the efficacy and effect on glycemic control of dulaglutide versus liraglutide in obese type 2 diabetic adolescents using metformin

to observe the efficacy, effect on glycemic control, impact on bmi and incidence of adverse effects of dulaglutide and to compare it to liraglutide in individuals aged thirteen to eighteen who have type 2 diabetes mellitus and are obese.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * obese * taking metformin * male or female exclusion criteria: * non obese * not taking metformin * taking other injectable diabetic medications
evaluation of beauty care before chemotherapy in women with breast cancer

Conditions: Breast Cancer

Summary: evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer


Eligibility criteria:
inclusion criteria: * breast cancer with no metastasis receiving adjuvant chemotherapy exclusion criteria:
comparison of two method antimetabolites application on corneal function in trabeculectomy surgery

Conditions: Glaucoma Patients Scheduled for Trabeculectomy

Summary: application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. however, mitomycin_c can be applied remain a concern before or after sclera flap dissection. mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. this study compares mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.


Eligibility criteria:
inclusion criteria: * age range between 18 to 80 years old * trabeculectomy to joac, poag, cacg, pxf, pigment dispersion syndrome. exclusion criteria: * secondary glaucoma (active uveitis, nvg, specific syndromes such as axenfeld rieger, iridocorneal endothelial syndrome, aniridia, peters, etc).
open-label extension study of de-immunized di-leu16-il2 immunocytokine administered in participants with b-cell nhl

Conditions: B-cell Non-Hodgkin Lymphoma

Summary: this is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of di-leu16-il2 while enrolled in the alopexx oncology dose-escalation ao-101 study (nct01874288). participants will be permitted to continue to receive di-leu16-il2 at the same dose, schedule, and route of administration they received during study ao-101 (main study). prior pre-treatment (for example, rituximab) will continue as before.


Eligibility criteria:
inclusion criteria: 1. participants currently entered on alopexx oncology study ao-101 2. participants who received 6 cycles of di-leu16-il2 on study ao-101. 3. documented clinical benefit following 6th cycle of di-leu16-il2 4. able to begin extension study within 8 weeks of receiving 6th cycle of di-leu16-il2 5. participants must have received prior rituximab-containing therapy. 6. participants in this extension study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. females of childbearing potential must have a negative serum pregnancy test on the days of dosing. a female of childbearing potential: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months. 7. provide written informed consent prior to any study procedures. exclusion criteria: 1. pregnant or lactating female 2. an immediate need for palliative radiotherapy or systemic corticosteroid therapy. 3. actively infected with or chronic carriers of hepatitis b virus (hbv) as demonstrated by positive hepatitis b core antibody (hbcab) or hepatitis b surface antigen (hbsag). participants who are sero-positive only, that is, surface antibody positive \[hbsab\], are permitted. 4. other significant active infection 5. major surgery, chemotherapy, investigational agent, or radiation within 30 days of day 1 6. uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury \[mmhg\]) or hypotension (systolic ≤ 90 mmhg) 7. history of prior therapy or a serious, uncontrolled medical disorder that in the investigator's opinion would impair participation in the study.

Keywords: nhl immunocytokine lymphoma non-hodgkin b-cell il (interleukin)
efficacy and safety of albiglutide in treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * bmi 20-45kg/m2 inclusive exclusion criteria: * females who are pregnant, lactating or \<6 weeks post-partum * current symptomatic heart failure (nyha class iii or iv)

Keywords: diabetes
observational non-interventional study with viramune® in combination with truvada® in hiv-infected patients

Conditions: HIV Infections

Summary: this observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with viramune (nevirapine) in combination with truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (hiv-rna below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of viramune (nevirapine) and truvada (tenofovir and emtricitabine).


Eligibility criteria:
inclusion criteria * male and female adult hiv type 1 infected patients, who have either not been treated previously, whose previous combination treatment with pis has failed, or who have to switch their previous treatment from protease inhibitors (pi) or non-nucleoside reverse transcriptase inhibitors (nnrt)i due to side effects or intolerability after achieving suppression of viral load below the limit of detection. * viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of hiv-1 infected patients with advanced or progressive immunodeficiency. * truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults. exclusion criteria * age \< 18 years * pregnant female patients * hypersensitivity to the active substance or to any of the excipients of viramune (nevirapine) or truvada (tenofovir and emtricitabine). * viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine. * viramune (nevirapine) should not be used in patients with severe hepatic impairment (child-pugh c) or pre-treatment aspartine transaminase (asat) or alanine transaminase (alat) \> 5 upper limit normal (uln) until baseline asat/alat are stabilised \< 5 uln. * viramune (nevirapine) should not be readministered in patients who previously had asat or alat \> 5 uln during viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of viramune (nevirapine) * herbal preparations containing st johns wort (hypericum perforatum) must not be used while taking viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine * the available pharmacokinetic data suggest that the concomitant use of rifampicin and viramune (nevirapine) is not recommended.
studying biomarkers in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: studying samples of tissue in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is studying biomarkers in patients with pancreatic cancer.

objectives: * to determine whether the cellular localization of brca1 can predict how patients with pancreatic cancer will respond to cytotoxic agents (e.g., fluorouracil or gemcitabine hydrochloride) or radiotherapy. * to identify pre-treatment markers that can be used to correlate with clinical outcomes of survival and recurrence. * to determine if a method of extracting and identifying secreted cytokines and growth factors from biopsy tissue can now be applied to the pancreatic cancer population. outline: tissue samples from biopsies performed during pancreatectomy are collected from the vanderbilt ingram cancer center human tissue acquisition core for laboratory biomarker studies. proteins secreted by cancer cells and/or cancer-associated cells are studied by extracting and identifying secreted cytokines and growth factors from biopsy tissue. the integrity of the dna repair pathway in pancreatic cancer is analyzed by rad51 and phosphorylated dna-pk foci formation. markers are correlated with clinical outcome. patients are followed for recurrence, relapse, and death from disease.

Eligibility criteria:
inclusion criteria * any subject with excess tissue collected at time of routine surgery for pancreatic cancer is eligible. * all subjects participating in this protocol will be followed for recurrence, relapse and death from disease

Keywords: stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer