Kornimate/medical-research-clean huggingface dataset:
post-treatment care of breast cancer survivors

Conditions: Breast Neoplasm

Summary: the overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in latina and non-hispanic women.

the proposed investigation is a randomized prospective evaluation of a survivorship intervention in improving the quality of care, treatment satisfaction and understanding of care in latina and caucasian breast cancer survivors treated in an urban academic medical center. patients will be recruited within 6 weeks of completing their last definitive breast cancer therapy (radiation or chemotherapy). patients will complete self administered baseline and follow-up questionnaires. following baseline evaluation patients will be randomized to receiving either written information for follow-up care of cancer survivors published by the national cancer institute (facing forward), or the survivorship intervention. patients will not be aware that they are participating in a randomized intervention. after verbally agreeing to participate they will be randomized to group a or b and will receive the corresponding consent. patients will be re-assessed 3 and 6 months after enrollment.

Eligibility criteria:
inclusion criteria: * participants will be screened for the following inclusion criteria: * age \>18 years * history of stage 0, i, ii, or iiia breast cancer and no evidence of recurrent disease * within 6 weeks of completion of breast cancer therapy (surgery, radiation or chemotherapy) * caucasian and/or hispanic (english or spanish-speaking) * willing to undergo a 1 hr cancer survivorship evaluation exclusion criteria: * patients with the following active conditions or behaviors will be excluded from participation: * evidence of recurrent or metastatic breast cancer * patients who have received surgery only with no adjuvant therapy * uncontrolled or significant psychiatric illness/social situations that would preclude completion of questionnaire or follow-up evaluation.

Keywords: cancer survivorship survivorship prescription cancer related anxiety
tips combined with variceal embolization for the prevention of variceal rebleeding in patients with cirrhosis

Conditions: Liver Cirrhosis

Summary: the purpose of this study is to determine whether tips combined with variceal embolization are effective in the prevention of variceal rebleeding in patients with liver cirrhosis.

variceal bleeding is one of the leading causes of death in patients with cirrhosis. patients with cirrhosis surviving a variceal bleeding are at high risk of rebleeding (over 60% at 1 year), and mortality from each rebleeding episode is about 20%. placement of tips is a well-established technique that is highly effective in preventing recurrent variceal bleeding, especially if the tips is created with an expanded polytetrafluoroethylene (eptfe)-covered stent, which has a significantly lower risk of shunt dysfunction than does tips created with bare stents. but the risk of hepatic encephalopathy greatly increases and the risk of recurrent variceal bleeding after tips placement remains an issue. besides an insufficient decrease in portosystemic pressure gradient after tips creation alone, fragile variceal vessels also are considered a risk factor for recurrent bleeding. accordingly, tips combined with variceal embolization has been advocated to achieve the best result possible in preventing recurrent variceal bleeding. however, in recent american association of the study of liver disease (aasld) practice guidelines and baveno v consensus, no treatment strategies were clearly recommended maybe because the exact efficacy of this strategy remains unclear and high-quality randomized controlled trials still lacks. so the investigators hypothesized that embolization of these collateral vessels may increase the blood flow within the shunt and into the liver, which can theoretically decrease the incidence of shunt dysfunction and encephalopathy, even can prolong the patients' survival.

Eligibility criteria:
inclusion criteria: * signed written informed consent * dignosis of cirrhosis (clinical or by liver biopsy) * admission due to variceal bleeding occurred 5 to 42 days prior and standard treatment for secondary prophylaxis failed * age 18 to 75 years exclusion criteria: * hepatic carcinoma and/or other malignancy diseases * portal vein thrombosis (≥50% of the lumen) * child-pugh score\>13 points * spontaneous recurrent hepatic encephalopathy * budd-chiari syndrome * large spontaneous portosystemic shunts * sepsis * spontaneous bacterial peritonitis * uncontrollable hypertension * serious cardiac or pulmonary dysfunction * renal failure * with tips contraindications * previous tips or collateral embolization, * pregnancy or breast-feeding * history of organ transplantation

Keywords: tips embolization variceal rebleeding
advantage: implementation and evaluation of an interprofessional tranistional care model for frail older adults

Conditions: Transitional Care; Multimorbidity; Geriatric Care

Summary: this clinical trial at the university department of geriatric medicine felix platter in basel, switzerland, is designed to evaluate a new transitional care model aimed at helping frail older adults after they get discharged from the hospital. the advantage study aims to explore the following questions: * does the new care model help reduce the number of patients who need to return to the hospital within 90 days? * how effective is the implementation of this care model? participants in the trial will be followed by advanced practice nurses for up to 90 days after hospital discharge. the patients and their caregivers will receive support in coordinating care, managing medications, and learning to manage the patient's health conditions on their own. additionally, they will have the opportunity to engage in discussions about advanced care planning.


Eligibility criteria:
inclusion criteria: * currently admitted to the acute or rehabilitation ward of university department of geriatric medicine * reside in basel-stadt * possess the ability to speak and comprehend the german language * scheduled to be discharged to their home * 65 years or older * identified by a clinician as having a high risk of deterioration due to frailty additionally, participants must meet at least one of the following criteria: * diagnosed with a complex chronic disease requiring support in self-management and disease management, or * facing socially challenging situations such as living alone without a supportive network or lacking a gp, or * admitted for an acute illness with a brief hospital stay (e.g., infection, cardiac decompensation) and need support in self- and disease management, and continuity of the therapy plan, including close monitoring. exclusion criteria: * residing in a nursing home or being newly admitted to one * lacking informal caregivers and exhibiting severe cognitive impairment (mms ≤23) * scoring \<50 on the motoric domain of the functional independence measure (fim) * having a psychiatric disorder that significantly impacts their ability to manage daily life at time of the discharge

Keywords: transitional care, frailty, rehospitalisation, geratric care
a prospective randomised multicenter study comparing the sliding hip screw and the intertan nail in trochanteric and subtrochanteric femoral fractures

Conditions: Trochanteric and Subtrochanteric Hip Fractures; Treatment With a New Nail or a Sliding Hip Screw

Summary: this is a study to compare the new nail "intertan" with a sliding hip screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures). are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?


Eligibility criteria:
inclusion criteria: * patients older than 60 years with a trochanteric or subtrochanteric hip fracture. exclusion criteria: * patients with pathologic fractures, patients already included with a fracture on the opposite side.
glucose optimisation with angiotensin ii antagonist losartan (goaal)

Conditions: Hypertension

Summary: to determine if angiotensin-ii at-1 receptor blockade(arb) may improve insulin sensitivity assessed by the hyperinsulinaemic isoglycaemic glucose clamp, more than ccb therapy at a comparable dose with regards to the blood pressure-lowering effect.

patients with hypertension have an increased prevalence of insulin resistance and an increased risk of developing diabetes mellitus with ageing. different antihypertensive regimens have varying effects on glucose metabolism and the development of diabetes mellitus. in a double-blind,randomized cross-over study we aim to compare the metabolic effects of 10 mg amlodipine and 100 mg losartan + 5 mg amlodipine in patients with hypertension and other risk factors for the metabolic syndrome. after a 4-week open label amlodipine 5 mg run-in period, all hypertensive patient will be randomized to additional treatment with either amlodipine 5 mg or losartan 100 mg for 8 weeks. at the end of this 8-week treatment-period we will do a physical examination, laboratory-tests, hyperinsulinaemic isoglycaemic glucose clamp, heart rate variability and baroreflex sensitivity measurements. following this is a 4-week wash-out phase where the subjects continue open label 5 mg amlodipine, before crossed over to the opposite treatment regimen for another 8 week before the final examination.

Eligibility criteria:
inclusion criteria: * essential hypertension with diastolic blood pressure 95-110 mmhg and systolic blood pressure \< 180 mmhg * previously untreated hypertension or treated with monotherapy (but not with ace-inhibitors or angiotensin ii-receptor blockers) * impaired glucose tolerance or impaired fasting glucose (fasting plasma glucose; 6.1-7.0 mmol/l (110-126 mg/dl) * age over 18 * informed consent * any one of these: microalbuminuria (urin excretion \>20 microg/min), dyslipidemia (hdl-cholesterol \ 1.7 mmol/l (150 mg/dl), waist to hip-ratio \>0.9 in men and \>0.85 in women, bmi \>28 kg/m2. exclusion criteria: * previous or current use of ace-inhibitors or angiotensin ii-receptor blockers * previous or current antidiabetic medications * "brittle" pre-diabetes where the investigator anticipates pharmacological treatment within next 6 months * hypertensive patients where the investigator anticipates polytherapy within next 6 months * female patient who is pregnant or nursing or planning pregnancy within the duration of the study

Keywords: angiotensin ii type i receptor blockers amlodipine calcium channel blockers diabetes mellitus hypertension insulin resistance losartan
hyponatremia due to poly ethylene glycol (peg)

Conditions: Hyponatremia

Summary: colonoscopy is a useful tool used in modern medicine and it is increasingly being employed for both diagnostic and therapeutic purposes. (polyethelene glycol)peg is very often used for bowel preparation.there are some cases of hyponatremia reported due to the use of peg. this study was designed to find frequency of sodium disorders after bowel cleansing by polyethylene glycol solution for colonoscopies in dr. ruth k.m. pfau, civil hospital karachi.

colonoscopy is a useful tool used in modern medicine and it is increasingly being employed for both diagnostic and therapeutic purposes. peg is very often used for bowel preparation. peg solutions clean the bowel with less water and electrolyte shifts, primarily by causing mechanical effect of large-volume lavage 1. however, there are some cases of hyponatremia reported due to the use of peg. life-threatening fluid and electrolyte disturbances are more likely to occur in patients with risk factors, such as old age, use of ssris and thiazide diuretics, chronic kidney disease, congestive heart failure or with a history of electrolyte abnormalities 2. although sporadic case reports of hyponatremia and other electrolyte imbalances after bowel preparation have been reported, but well-designed studies are lacking on this subject. literature search did not reveal any local studies on this subject. this study was designed to find frequency of sodium disorders after bowel cleansing by polyethylene glycol solution for colonoscopies in dr. ruth k.m. pfau, civil hospital karachi.

Eligibility criteria:
inclusion criteria: 1. patients of either gender of age between 18-80 years undergoing colonoscopy. 2. patients should have normal electrolytes before taking solution. 3. patients should have given informed consent. 4. patients should have taken solution adequately before procedure. exclusion criteria: 1. patients with chronic kidney disease 2. patients on diuretics 3. patients who are hyponatremic on first sample, i.e., before taking bowel cleansing agent. 4. hypothyroidism -
efficacy study on the lipid-lowering effect of plant sterols and fish oil

Conditions: Healthy; Mildly Elevated Cholesterol Levels

Summary: plant sterols and fish fatty acids are known to affect the blood lipid profile. this randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.


Eligibility criteria:
inclusion criteria: * apparently healthy men and women * age ≥ 25 and ≤ 75 years old * body mass index (bmi) ≥ 18 and ≤ 30 kg/m2 * total cholesterol levels at screening ≥ 5.0 and ≤ 8.0 mmol/l * 10-year cvd risk equal or lower than 10% according to "score" * blood pressure, heart rate, hematological parameters, clinical chemical parameters within normal reference ranges * informed consent and biobank consent signed * willing to comply to study protocol during study * agreeing to be informed about medically relevant personal test-results by a physician * not smoking * accessible veins on the forearm * habitually consuming spreads exclusion criteria: * pregnant or having the wish to become pregnant, or lactating * use of prescribed medication which may interfere with study measurements * use of antibiotics in the 3 months before screening or during the study * use of any medically- or self-prescribed diet with the purpose to reduce weight * intolerance for gluten or lactose * reported food allergy * having bleeding disorders * recent blood donation * excessive alcohol consumption * strenuous exercise * reported weight change ≥ 10 % of body weight or use of prescribed weight reduction drugs * recent participation in another nutritional or medical trial * participation in night shift work

Keywords: dose-response study blood lipid profile plant sterols fish oil
a pilot study of lithium in progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether lithium carbonate is safe, well-tolerated, and effective at treating progressive forms of multiple sclerosis.

in progressive multiple sclerosis (ms), patients experience worsening disability through a combination of inflammatory and neuro-degenerative processes. to test whether low-dose lithium carbonate ameliorates disability accumulation in progressive ms, patients with progressive ms were randomly assigned to take lithium in either the first or second year of a two-year trial. the trial was designed as a cross-over study to maximize exposure to lithium to for two reasons: 1) to increase the number of persons with ms exposed to lithium for purposes of assessing safety and tolerance; and 2) to increase the power to detect changes in the primary radiological outcome (change in brain volume) and also in secondary clinical outcomes (disability, mood, fatigue, cognition).

Eligibility criteria:
inclusion criteria: * diagnosis of a progressive subtype of multiple sclerosis by revised 2005 mcdonald criteria. * edss of 3.0-6.5 * ages 30-65 * must be mentally capable of providing informed consent and following study guidelines. exclusion criteria: * relapse or steroid treatment within 1 month of trial entry. * any current or previous treatment with mitoxantrone, azathioprine, methotrexate, mycophenolate, cyclophosphamide, or any experimental therapy. * women who are pregnant, wishing to become pregnant in the coming 30 months, or are breastfeeding. * sexually active women unwilling to use reliable contraception (oral contraceptives, condom, iud). * patients with known kidney dysfunction or creatinine \>1.4; known cardiac arrhythmia or significant conduction abnormality on ekg; uncontrolled thyroid disease or tsh \>20% above the upper limit of normal; uncontrolled psoriasis, hiv, or any other severe medical condition. * patients with a history of unstable psychiatric illness or active severe depression. * patients with a history of seizure. * concurrent use of any of the following medications: antipsychotics, diuretics, digoxin, or iodide salts. * use of non-steroidal anti-inflammatory drugs (nsaids) 5 or more days a week. * patients with a history of substance abuse in the past year. * patients sensitive to gadolinium, or who are unable to undergo the required number of mri scans. * unable to speak or understand sufficient english to consent or complete study procedures. * patients unable or unwilling to provide informed consent.

Keywords: multiple sclerosis lithium
effect of saffron supplementation on macular cone-mediated function in age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: this is a pilot interventional study whose aim is to determine the effect of a dietary supplementation with a crocus sativus extract, saffron, on macular cone-mediated function in patients with early age-related macular degeneration (amd). pre-clinical evidence ( maccarone r, di marco s, bisti s. saffron supplement maintains morphology and function after exposure to damaging light in mammalian retina. invest ophthalmol vis sci. 2008 mar;49(3):1254-61.) indicates the potential effectiveness of saffron as a retinal neuroprotectant in animal models of retinal degenerative disorders.the macular function will be tested by visual acuity and macular cone-mediated electroretinogram (focal electroretinogram, ferg) according to a standardized technique (see citations).

a group of 30 amd patients with typical lesions (drusen and/or retinal pigment epithelial defects) and relatively preserved central retinal function and visual acuity will be enrolled. amd patients will be randomly divided into two groups: 1. placebo group \[n = 15), taking for three months an oral placebo; 2. saffron group (n = 15), taking saffron oral treatment (20 mg/day) for three months. after three months of placebo or saffron supplementation, patients will be tested with standard ophthalmic examination and fergs. then, placebo with saffron and vice-versa will be changed to the same patients in a cross-over design. after a further three month period of placebo or study drug supplementation, patients will undergo again a standard ophthalmic examination, and ferg. throughout the study, both patients and experimenters will be masked as to the identity of pills (i.e. whether placebo or study drug), whose identification key number will be kept in a sealed envelope that will be opened only at the completion of the study. therapeutic compliance will be tested by careful questioning, either at two weeks of treatment (by telephone interview) or at the end of the treatment period, as well as by pill count. main outcome measures of the study will be ferg amplitude and phase.

Eligibility criteria:
inclusion criteria: * age \> 55 yrs * diagnosis of early, non exudative amd * visual acuity of 20/40 or better exclusion criteria: * concomitant ocular or systemic disorders which may affect macular function * drugs that may affect macular function

Keywords: amd retinal function neuroprotection
nplate® pregnancy exposure registry

Conditions: Birth Defect; Spontaneous Abortions; Low Birth Weight

Summary: us study to estimate the prevalence at birth of major birth defects (ie, those that cause significant functional or cosmetic impairment, require surgery, or are life-limiting) in children born to mothers who have received nplate® therapy at any time during the pregnancy.

the purpose of the nper is to monitor pregnancies exposed to nplate® and to detect and record serious adverse events in infants up to one year after birth. the lack of adequate human fetal safety data for nplate® makes the nper an important component of the pharmacovigilance program on the safety of this drug. with respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Eligibility criteria:
inclusion criteria: * eligible subjects will be currently pregnant women residing in the us who: have had any exposure to nplate® at any time during the pregnancy, which is defined as the period between first day of the last menstrual period (lmp) (ie, within two weeks of conception) up to any date before the date of delivery or end of the pregnancy. the date of conception will be defined as fourteen days prior to the next expected menstrual period for women who report a regular menstrual cycle. if the date of the first day of the lmp is unclear, or if the estimated date of conception as determined by a first-trimester ultrasound differs by more than one week from the date as determined by the first day of lmp, the first-trimester ultrasound-derived date will be used to estimate the timing of exposure to nplate®, as well as timing of enrollment. if neither a clear date of the first day of the lmp nor a first-trimester ultrasound is available, the estimated date of conception for purposes of enrollment will be determined by best estimate of the woman's prenatal care provider. * agree to enroll at any time from the estimated date of conception up to any date before the date of delivery or end of the pregnancy and who have not already had prenatal diagnosis of any major structural birth defect in the current pregnancy prior to enrollment. * agree to provide consent for participation in the registry including follow-up interviews. exclusion criteria: * subjects will be ineligible for study participation if any of the following apply: * exposure to nplate® did not occur during pregnancy. * prior knowledge of prenatal diagnosis of a birth defect. patients who fall under this category will be encouraged to call the amgen psp toll free number for enrollment and follow-up. * cases reported to the nper after completion of the exposed pregnancy. patients who fall under this category will be encouraged to call the amgen psp toll free number for enrollment and follow-up.