Kornimate/medical-research-clean huggingface dataset:
evaluatıon of sympathetıc nervous system fındıngs and theır relatıonshıp wıth symptoms ın patıents wıth breast cancer related lymphedema

Conditions: Lymphedema, Breast Cancer

Summary: the aim of this study was to evaluate the sympathetic nervous system, small fiber functions and autonomic symptoms in patients with breast cancer related lymphedema and to investigate the relationship between these findings and patients' symptoms.

this observational cross-sectional study aims to evaluate sympathetic nervous system activity, small fiber function, and autonomic symptoms in patients with breast cancer related lymphedema. electrophysiological parameters, including sympathetic skin response (ssr) and cutaneous silent period (csp), will be recorded from both the affected and unaffected limbs using standardized neurophysiological techniques. additionally, autonomic symptoms will be assessed using the composite autonomic symptom score 31 (compass-31), and the impact of lymphedema on daily life will be evaluated with the lymphedema life impact scale (llis). the study hypothesizes that sympathetic dysfunction and small fiber involvement may contribute to the pathophysiology of lymphedema and correlate with subjective symptoms such as pain, heaviness, and tightness. findings from this study are expected to provide insights into the potential role of the autonomic nervous system in breast cancer-related lymphedema and may support future consideration of sympathetic nervous system-targeted treatments.

Eligibility criteria:
inclusion criteria: * patient age group between 18-75 years * to have been diagnosed with breast cancer-related lymphedema by imaging and/or clinical diagnostic methods exclusion criteria: history of upper extremity lymphedema due to causes other than breast cancer * lymphedema in other body parts * diagnosis of polyneuropathy or entrapment neuropathy in the upper extremity * presence of active infection at the assessment site * presence of congenital or acquired malformations at the evaluation site * those with any medical condition that may cause edema, such as severe heart or kidney failure
a study of the glaukos trabecular micro-bypass stent in refractory open angle glaucoma subjects

Conditions: Open-Angle Glaucoma

Summary: the purpose of this study is to evaluate the safety and efficacy of the istent trabecular micro-bypass stent in reducing intraocular pressure (iop) in refractory open-angle glaucoma subjects.

glaukos corporation conducted a clinical research study at multiple (approximately 7) investigational sites within europe.

Eligibility criteria:
inclusion criteria: * diagnosed with primary open-angle glaucoma (poag) * subject on maximally tolerated medical therapy or where noncompliance with medication has been document * subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, trabeculoplasty(alt), viscocanalostomy, collagen implant) exclusion criteria: * angle closure glaucoma * fellow eye already enrolled

Keywords: open angle glaucoma refractory surgery
safinamide in idiopathic parkinson's disease (ipd) with motor fluctuations, as add-on to levodopa

Conditions: Idiopathic Parkinson's Disease

Summary: parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. the understanding that pd is a syndrome of dopamine (da) deficiency led to the introduction in the clinical practice of l-dopa, a precursor of da that crosses the blood brain barrier, and also to the use of selective inhibitors of mao-b, the major da metabolising enzyme in man. safinamide is an inhibitor of mao-b. this is a phase iii trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic parkinson's disease. the principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.


Eligibility criteria:
inclusion criteria: male and female between the ages of 30 to 80 years with diagnosis of idiopathic parkinson's disease of more than 5 years duration, with a hoehn and yahr stage of i-iv during an "off" phase. be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks. have motor fluctuations, with \>1.5 hours "off" time during the day. be able to maintain an accurate and complete diary (18-hour) exclusion criteria: patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;. be in a late stage of parkinson's disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms. current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months. have received treatment with safinamide previously. history of, or current depression psychosis (e.g. schizophrenia or psychotic depression) evidence of dementia or cognitive dysfunction. history of allergic response to anticonvulsants, levodopa, or other anti-parkinsonian agents. hypersensitivity or contraindications to mao-b inhibitors. ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
retrospective study of the use of belantamab mafodotin (blenrep®) in patients with relapsed and/or refractory multiple myeloma (rrmm) in spain.

Conditions: RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA

Summary: the proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with rrmm included in the compassionate use or in the expanded access program in spain between november 2019 and june 2021. the focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (orr), duration of response (dor), progression free survival (pfs), overall survival (os), and the safety of single agent belantamab mafodotin in patients with rrmm. subjects may receive treatment until progression. myeloma disease status will be evaluated locally for response and progression per international myeloma working group (imwg) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).

the proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with rrmm included in the compassionate use or in the expanded access program in spain between november 2019 and june 2021. subjects may receive treatment until progression. myeloma disease status will be evaluated locally for response and progression per international myeloma working group (imwg) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first). the study has the following objectives: primary objective - the primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with rrmm. secondary objectives: * describe the safety and tolerability of single-agent belantamab mafodotin. * the overall incidence of ophthalmologic complications. * estimate duration of response (dor). * estimate time to response (ttr). * estimate time to next treatment (ttnt). * estimate progression-free survival (pfs) and overall survival (os). * type of treatment administered after single-agent belantamab mafodotin and estimate pfs2.

Eligibility criteria:
inclusion criteria: * reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in spain between november 2019 and june 2021
feasibility of pharmaceutical interventions in elderly heart failure patients.

Conditions: Heart Failure

Summary: heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality rates, as well as diminishing hospitalizations. also, pharmacist collaboration has been shown to have a beneficial impact on heart failure related outcomes. regardless, a high residual event rate is to be noted. in our pilot study, we wished to document whether a clinical pharmacist could still play a role in the heart failure management of an elderly inpatient heart failure population.


Eligibility criteria:
inclusion criteria: * 75 years or older * diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'european society of cardiology guidelines on acute and chronic heart failure' * diagnosis had to be confirmed by a recent echocardiogram exclusion criteria: * not dutch speaking * treatment restrictions had been applied on admission

Keywords: elderly frailty polypharmacy medication review clinical pharmacy services
va106483 dose response study in elderly males

Conditions: Nocturia

Summary: the main purpose of the study is to evaluate the way va106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.

va106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). nocturia is a condition that often worsens as sufferers get older. this may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. the only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. however, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. this side-effect has not been observed with va106483, making it potentially suitable for treating the elderly. the purpose of this study is to confirm that duration of action of va106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration. subjects will be water-loaded, dosed with either va106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.

Eligibility criteria:
inclusion criteria: * male, age: 65 years and above * using adequate contraception * medical history without clinically significant pathologies; no evidence of serious pathology or disease * physical examination parameters without signs of serious disease * no clinically significant ecg and lab safety tests (sodium must be within normal range) * willing and able to participate and provides written informed consent exclusion criteria: * cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics * supine arterial blood pressure higher than 170/100 mmhg or less than 105/60 mm hg * presence of poorly controlled endocrine disorders * renal insufficiency, active hepatic and/or biliary disease * hyponatraemia. serum sodium level must be within normal limits * syndrome of inappropriate antidiuretic hormone (adh) secretion * symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus * known hypersensitivity to the ip or any constituent of the ip * use of any non-prescription preparation within 72 hours prior to study entry, with the exception of defined pain killers * a history of alcohol abuse or drug addiction within the last 2 years * positive screen for hiv, hepatitis b or c * currently taking any diuretics or any concomitant medication known to be a cytochrome 3a4 inhibitor * other protocol defined eligibility criteria may apply.

Keywords: nocturia pharmacokinetics pharmacodynamics water-loading elderly males
stereotactic body radiotherapy dose escalation in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study is to determine the maximum tolerated dose (mtd) of five fraction stereotactic radiotherapy (sbrt) in pancreatic cancer.

this trial is designed to find the maximum tolerated dose of radiation under a fixed 5-fraction sbrt regimen escalating the dose from 40 gy in 5 fractions, to 60 gy in 5 fractions, at 5 gy intervals.

Eligibility criteria:
inclusion criteria: * diagnosis: histologically-proven invasive adenocarcinoma of the pancreas. * disease status: medically unresectable (any stage), or locally advanced (stage iii). * tumor location: primary tumor may be located anywhere in the pancreas. * treatment eligibility: the patient must be able to have fiducial markers implanted into the pancreatic tumor, and receive radiation regimen as specified in the protocol. * performance level: karnofsky performance status ≥ 60 * adequate renal function defined as: serum creatinine ≤ 1.5 x upper limit of normal * informed consent: all subjects must sign a written informed consent. exclusion criteria: * pregnancy or breast-feeding: pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events. (note: serum pregnancy tests must be obtained in women of child bearing potential). sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study. * life expectancy \< 6 months * the patient cannot have had prior radiation therapy to the thorax or upper abdomen. * incarcerated individuals * subjects unable to give informed consent
braden pressure ulcer scale for prediction of the intensive care length of stay

Conditions: Intensive Care Unit ICU; Length of ICU Stay; Pressure Ulcer Risk; Scale Reliability Validity

Summary: the aim of this study is to predict the length of intensive care unit stay of patients treated in a tertiary general intensive care unit with the help of the braden risk assesment scale, which is used to predict the risk of pressure ulcers. the main question it aims to answer is: * does high braden scales predict the long lenght of stay? braden scales of patients admitted to the intensive care unit were recorded every day.

intensive care units are specialized units where patients with multiple comorbidities are treated. the length of stay in intensive care varies according to the characteristics of the patient, the disease and the center. prolonged intensive care stay causes an increase in mortality . it has been reported that the severity of the disease as well as the comorbidities of the patients contribute to prolonged stay . one third of patients with stay longer than seven days were evaluated as more fragile than before hospital admission. prolonged intensive care length of stay leads to an increase in morbidity and mortality, bed demand and costs. the braden pressure ulcer scale was developed by braden et al. in 1987 . scoring is done under six different headings evaluating sensory perception, humidity, activity, mobility, nutrition and friction/cutting. it has been reported as an effective tool for evaluating pressure ulcer development in intensive care patients. in this scoring system, there are different assessment steps such as mobility, nutrition, sensory perception, etc., which allows the assessment of the functional capacity of the patients at the time of admission. in a study of elderly dementia patients, the braden scale was found to be effective in predicting 90-day mortality. in a retrospective evaluation of patients with heart failure, the braden scale was reported to predict 30-day mortality. the aim of our study is to predict the length of intensive care stay by analyzing the braden scales calculated on the day of hospitalization.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients treated in intensive care * patients treated with diagnoses other than covid-19 * patients without missing data in the hospital electronic data system * patients hospitalized for more than 24 hours exclusion criteria: * patients younger than 18 years * patients treated for covid-19 disease * patients with missing data in the hospital electronic data system * patients hospitalized for less than 24 hours

Keywords: braden risk assesment scale length of stay icu
observational study of a protease inhibitor (pi) containing regimen in subjects with pi mutations selected during prior treatment with gw433908 (fosamprenavir)

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: this study will assess the efficacy of subsequent protease inhibitor (pi)-containing therapy in subjects who have acquired hiv-1 protease mutations whilst receiving a gw433908 (fosamprenavir)-containing regimen.


Eligibility criteria:
inclusion criteria: * prior participation in study apv30005 and one of the following studies: apv30001, apv30002, azl30006, apv30003. * must be failing virologically (\>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new apv-associated protease mutation: v32i (+/- i47v), i50v, i54l/m, i84v acquired since commencing treatment with gw433908. exclusion criteria: * have 2 or more of the primary resistance mutations d30n, g48v, v82a/f/t/s and l90m. * have a medical need for use of an non-nucleoside reductase transferase inhibitor (nnrti). * have an acute cdc class c event requiring therapeutic intervention. * are pregnant or lactating. * have any other condition which in the opinion of the investigator would preclude their participation.

Keywords: protease inhibitor ritonavir gw433908 hiv-1 fosamprenavir
monitoring for cancer spread to the central nervous system (cns) in people with breast cancer

Conditions: Breast Cancer

Summary: the researchers doing this study think that performing scans of the brain and testing cerebrospinal fluid (csf) in people with her2-positive breast cancer may be an effective way of identifying the early onset of cns metastases (such as brain cancer). if the researchers can identify the early onset of cns metastases, they can immediately treat that cancer and possibly prevent it from worsening. currently, people with breast cancer don't usually have scans of the brain or csf testing unless they are experiencing symptoms of cns metastases.


Eligibility criteria:
inclusion criteria: * patients with stage iv metastatic her2+ breast cancer without cns disease s/p 1 or more lines of her2 directed therapy (cohort a only) * patients with stage ii-iii her2+ breast cancer without cns disease (cohort b only) * male and female participants age ≥18 years * her2+ as defined by asco/cap guidelines\* * ability to undergo bedside lumbar puncture to obtain cerebrospinal fluid; if beside lp is not successful due to patient discomfort or inability to obtain spinal fluid then patients will be offered lp through interventional radiology and patients will continue to be monitored on study * patients with breast implants and/or tissue expanders are eligible if they are able to safely undergo an mri * able to provide written informed consent \*asco/cap guidelines: her2+ defined as ihc 3+ positive and/or by ish average copy number ≥ 6 signals/cell exclusion criteria: * patients who are unable to undergo mri with gadolinium * patients with cns metastases on screening mri * patients with positive cytology on screening bedside lumbar puncture

Keywords: central nervous system her2+ breast 21-140
vitamin d levels in non-immediate drug hypersensitivity case-control study

Conditions: Stevens-Johnson Syndrome; Drug Reaction With Eosinophilia and Systemic Symptom; Maculopapular Exanthem; Vitamin D Deficiency; Drug-Induced Rash

Summary: serum vitamin d levels in drug-induced non-immediate reactions

the study of serum vitamin d levels in patients presented with drug-induced non-immediate cutaneous adverse reactions compared to those in drug-tolerant control subjects

Eligibility criteria:
inclusion criteria: * diagnosed with sjs/ten, dress, agep, mpe, or fde as mentioned above exclusion criteria: * reactions from drugs with known strong genetic predispositions (allopurinol, carbamazepine, abacavir) * receiving vitamin d supplement

Keywords: vitamin d stevens-johnson syndrome drug reaction with eosinophilia and systemic symptom maculopapular exanthem drug allergy drug hypersensitivity
sofosbuvir with peginterferon alfa 2a and ribavirin for 12 weeks in treatment-naive subjects with chronic genotype 1, 4, 5, or 6 hcv infection

Conditions: Chronic Hepatitis C

Summary: this study was to assess whether sofosbuvir in combination with ribavirin (rbv) and pegylated interferon alfa 2a (peg) administered for 12 weeks is safe and effective in patients with hepatitis c virus (hcv) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (svr) 12 weeks after discontinuation of therapy (svr12).


Eligibility criteria:
inclusion criteria: * infection with hcv genotype 1, 4, 5, or 6 * cirrhosis determination * subject met the following classifications: * treatment-naive * screening laboratory values within defined thresholds * not treated with any investigational drug or device within 30 days of screening * use of highly effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * prior exposure to an direct-acting antiviral targeting the hcv nonstructural protein (ns)5b polymerase * pregnant or nursing female, or male with pregnant female partner * current or prior history of clinical hepatic decompensation * history of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol * excessive alcohol ingestion or significant drug abuse

Keywords: hcv genotype 1 (gt-1) hcv genotype 4 (gt-4) hcv genotype 5 (gt-5) hcv genotype 6 (gt-6) hcv sustained virologic response direct acting antiviral combination therapy treatment-naïve gs-7977 ribavirin rbv peginterferon alfa 2a peg
marijuana effects on simulated driving performance

Conditions: Cannabis; Cannabis Use; Marijuana; Marijuana Usage; Alcohol Drinking

Summary: this study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.


Eligibility criteria:
inclusion criteria: * healthy, adult participants * ages 21-50 * history of marijuana use * history of alcohol use exclusion criteria: * clinically significant medical conditions * ongoing/significant drug use outside of marijuana and alcohol use

Keywords: simulated driving, outpatient