Kornimate/medical-research-clean huggingface dataset:
a study of cg-806 in patients with relapsed or refractory cll/sll or non-hodgkin's lymphomas

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Non-Hodgkin's Lymphoma

Summary: this study is being done to evaluate the safety, tolerability and effectiveness of oral cg-806 for the treatment of patients with chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), or non-hodgkin's lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

this is a multicenter, open-label, phase ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of cg-806 in ascending cohorts (3+3 design) to determine the mtd or recommended dose in patients with relapsed or refractory cll/sll or non-hodgkin's lymphoma patients. this is to be followed by a cohort expansion phase at the mtd or recommended oral dose.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * life expectancy of at least 2 months * ecog performance status ≤ 2 * patients must be able to swallow capsules * adequate hematologic parameters, unless cytopenias are disease caused * adequate renal, liver and cardiac function parameters exclusion criteria: * patients with gvhd requiring systemic immunosuppressive therapy * uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder * clinically significant intravascular coagulation * treatment with other investigational drugs within 14 days prior to first study treatment administration

Keywords: oral dlbcl pmbcl bclu gzl mcl fl mzl wm lpl cll sll
the effect of high-dose remifentanil on established sunburn-induced hyperalgesia in human volunteers (highdose remisun)

Conditions: Hyperalgesia

Summary: treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. an injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (ltp), i.e., a change in the synaptic interaction between neurons. opioids are the gold standard for the symptomatic therapy of moderate to severe pain. now, in animal studies the investigators have discovered previously unrecognized effects of opioids. uv-b irradaition of the skin of the thigh is an established model of priamary and secondary hyperalgeisa in humans. the investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after uv-b irradiation in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial, at a dose corresponding to 0.7 µg kg-1 min-1.


Eligibility criteria:
inclusion criteria: * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination * drug free for 1 week prior to the study day exclusion criteria: * regular use of medication especially analgesics * abuse of alcoholic beverages, drug abuse * history of asthma * participation in a clinical trial in the 2 weeks preceding the study * symptoms of a clinically relevant illness in the 2 weeks before the first study day * resting systolic blood pressure \> 135 mmhg or diastolic blood pressure \> 85 mmhg * acute skin diseases like sunburn on the relevant areas or skin lesions * pregnancy or breast feeding * uv sensitive skin conditions, like xeroderma pigmentosa

Keywords: sunburn remifentanil hyperalgesia
a clinical study to evaluate the safety of ospemifene

Conditions: Atrophy; Vaginal Diseases

Summary: the purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of vva in postmenopausal women with intact uterus.


Eligibility criteria:
inclusion criteria: * naturally or surgically menopausal * intact uterus * vaginal ph greater than 5.0 * 5% or fewer superficial cells in maturation index of vaginal smear exclusion criteria: * evidence of endometrial hyperplasia, cancer or other pathology * abnormal pap smear * uterine bleeding of unknown origin or uterine polyps * current vaginal infection requiring medication * use of hormonal medications * clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Keywords: urogenital atrophy menopausal symptoms vulvar and vaginal atrophy in postmenopausal women vaginal atrophy
clinical validation of immunovia next-generation blood biomarker test to detect early-stage pancreatic cancer

Conditions: Pancreatic Cancer Stage I; Pancreatic Cancer Stage II; Cancer Diagnosis; PDAC - Pancreatic Ductal Adenocarcinoma

Summary: this is a case-control study to clinically validate the performance of a protein biomarker test to differentiate stage i and stage ii pancreatic ductal adenocarcinoma (pdac) patient samples from samples acquired from control patients not diagnosed with pdac but at increased risk of disease due to familial/genetic history or clinical symptoms.

this case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples. serum samples were collected for analysis from patients with stages i and ii pancreatic ductal adenocarcinoma (pdac) and non-pdac controls of similar demographics who were at increased risk of pdac because their familial or genetic history or clinical symptoms. investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. analysis of blood samples will be conducted in immunovia's laboratory in durham, nc by personnel who are blinded to subject data. biomarker results will be analyzed using three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.

Eligibility criteria:
inclusion criteria: * informed consent available * \> 45 years of age * pdac cases * treatment-naïve, pathologically confirmed pdac stage i or stage ii * sporadic or familial/genetic pdac * controls * individuals at high risk for pdac because of their familial and/or genetic history * individuals with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of pdac who were found to not have pdac based on clinical investigation (imaging evidence within 6 months of blood draw) * controls will be selected to have similar demographic features (age/gender) to pdac patients, as possible. exclusion criteria: * prior treatment for pdac (i.e., prior resection, radiotherapy, or chemotherapy) * current immunosuppressive (e.g. systemic steroid therapy) or chemotherapy * major surgery or significant trauma within 12 weeks prior to blood sample collection * non-pdac malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria) * control patients who currently have * biliary obstruction secondary to gallstones * prior diagnosis or imaging evidence of chronic pancreatitis * cystic pancreatic lesions \>3.0 cm in diameter or showing worrisome features according to fukuoka consensus guidelines.

Keywords: pdac pancreatic cancer early detection pancreatic cancer stage i pancreatic cancer stage ii pancreatic cancer diagnosis pancreatic ductal adenocarcinoma pancreatic cancer detection
teaching obesity treatment options to adult learners trial

Conditions: Obesity; Patient Education; Weight Loss

Summary: obesity is the second leading cause of death in the u.s. the treatment of obesity and its related health issues, including cardiovascular disease and diabetes, exceeds $150 billion annually. "morbidly" or "severely" obese patients - defined by a body mass index \[bmi\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to their weight. within the veterans health administration (va) system, nearly 600,000 patients are severely obese. these veterans create significant costs for the va system, experience poorer quality of life, and have shortened lifespans. bariatric surgery is the most effective treatment for severe obesity for weight loss, resolving weight-related health issues, and quality of life. bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. however, less than 1% of veterans who qualify for bariatric surgery undergo it. reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. the goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to improve the care that severely obese veterans receive.

obesity is the second leading cause of death in the u.s. the treatment of obesity and its related comorbidities, including cardiovascular disease and diabetes, exceeds $150 billion annually. "morbidly" or "severely" obese patients - defined by a body mass index \[bmi\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to the metabolic and physiologic derangements that occur with severe obesity. within the veterans health administration (va) system, nearly 600,000 patients are severely obese. these veterans exert significant costs on the va system, experience poorer quality of life, and have shortened lifespans. bariatric surgery is the most effective treatment for severe obesity for weight loss, comorbidity resolution, and quality of life. bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. however, less than 1% of veterans who qualify for bariatric surgery undergo it. reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. the goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to optimize the care that severely obese veterans receive.

Eligibility criteria:
inclusion criteria: * veterans scheduled to attend an in-person move! visit led by a dietitian at the main va hospital. exclusion criteria: * no access to telephone, doesn't speak english as their primary language, has undergone bariatric surgery

Keywords: obesity patient education weight loss
lipoprotein(a) in patients with cardiovascular disease (cvd)

Conditions: Cardiovascular Disease and Lipoprotein(a)

Summary: the study is conducted to improve knowledge about the epidemiology of lipoprotein(a) in patients with established cardiovascular disease (cvd).


Eligibility criteria:
inclusion criteria: * signed informed consent * established cvd defined as one of the following: * history of a myocardial infarction (mi) ≥3 months and ≤10 years before the study visit * history of ischemic stroke ≥ 3 months and ≤ 10 years before the study visit * symptomatic pad (intermitted claudication with ankle-brachial index ≤0.90 and/or lower limb amputation or re-vascularization due to lower limb ischemia exclusion criteria: - patients currently enrolled in clinical studies with investigational drugs

Keywords: cvd, lipoprotein (a),
levofloxacin-containing therapies in second line helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: asia pacific consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after helicobacter pylori (h. pylori) eradication failure when bismuth salts are not available. the investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.

in this randomized-controlled trial , the investigator recruited participants with h pylori infection after failure of first line standard triple therapy. using a computer-generated randomization sequence, the investigators randomly allocated patients to either 10-day levofloxacin-containing sequential (ealm, esomeprazole 40 mg b.d., amoxicillin 1 g b.d.for 5 days and followed by esomeprazole 40 mg b.d., levofloxacin 500 mg qd and metronidazole for 5 days) or 10-day levofloxacin-containing triple therapy (eal, esomeprazole 40 mg b.d., amoxicillin 1 g b.d., and levofloxacin 500 mg qd) at a 1:1 ratio. the primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Eligibility criteria:
inclusion criteria: * consecutive h. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (ppi twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily) exclusion criteria: * ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks * use of non-steroidal anti-inflammatory drugs within the prior 4 weeks * participants with allergic history to the medications used * participants with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women.

Keywords: helicobacter pylori proton pump inhibitor eradication
randomized trial to assess efficacy of pufa for the maintenance of sinus rhythm in persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 pufa is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.

atrial fibrillation (af) impose a substantial and growing economic burden on health care expenditures. in patients with persistent af, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow af to continue and ensure that the ventricular rate is controlled (rate control). as it has been stated, it goes without saying that if we could prevent atrial fibrillation (af) or restore and maintain sinus rhythm in patients suffering from persistent af, without any penalties due to the unwanted effects of drugs or incomplete suppression of af and its thromboembolic complications, every physician would do so. current strategies however, are limited to achieve such desirable goal. in the last years a growing amount of evidence and attention regarding the cardio-protective role of omega 3 fatty acids (n-3 pufa) became progressively clear and appealing. epidemiological studies and randomized controlled trials confirms the role of n-3 pufa in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. these effects seems to be mediated mostly by an anti-arrhythmogenic effect. basic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. recently both basic research and clinical science suggested a role of n-3 pufa for the prevention and treatment of supraventricular arrhythmias, particularly af. the purpose of the study is to show that the addition of n-3 pufa on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.

Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation exclusion criteria: * contraindications or known hypersensitivity to n-3 pufa * current treatment with n-3 pufa for any reason * heart failure nyha class iv * coronary artery bypass surgery or valve replacement within the past 3 months * planned cardiac procedures * known sick-sinus syndrome * diagnosis of wolff-parkinson-white * clinical significant valvular etiologies * presence of arrhythmia associated with an acute reversible condition * advanced chronic lung disease * contraindications for anticoagulation therapy * pregnancy or lactation * any non cardiac illness associated with a life expectancy of \< 2 years * treatment with any investigational agent within 3 month before randomization * any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure

Conditions: Acute Hypoxemic Respiratory Failure; Hematologic Malignancy

Summary: effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure

acute respiratory failure (arf) is the leading reason for icu admission in immunocompromised patients. usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve spo2≥95%. high-flow nasal oxygen \[hfno\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. by providing warmed and humidified gas, hfno allows the delivery of higher flow rates \[of up to 60 l/min\] via nasal cannula devices, with fraction of inspired oxygen (fio2) values of nearly 100%. physiological benefits of hfno consist of higher and constant fio2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment. clinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure however, although preliminary data establish the feasibility and safety of this technique, hfno has never been properly evaluated in immunocompromised patients. thus, this project aims at demonstrating that hfno is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation

Eligibility criteria:
inclusion criteria: * known immunosuppression defined as haematological malignancy. * need for oxygen therapy defined as with oxygen free arterial blood gas examination one or more of the following: (a) pao2/fio2\<300 mmhg (b) paco2≤45 mmhg (c) sao2\<92% * respiratory distress with a respiratory rate \>22/min exclusion criteria: * refusal of study participation * pregnancy or breastfeeding * hypercapnia with a formal indication for non-invasive mechanical ventilation (nimv) (paco2 ≥ 45 mmhg) * patients whose clinicians have decided on nimv (non-invasive mechanical ventilation) and imv (invasive mechanical ventilation) * haemodynamic instability (mean arterial pressure \<65 mmhg) * vasopressor needs * awareness confusion and disorientation

Keywords: respiratory failure immuncompromise patients high flow oxygen
a 12 week study to evaluate the efficacy of an eye cream

Conditions: Periorbital Hyperpigmentation; Periorbital Edema; Fine Lines; Wrinkle

Summary: this single center, open-label clinical study was conducted to assess the efficacy and tolerance of a topical eye cream when used over the course of 12 weeks by healthy women with moderate to severe under-eye dark circles, moderate under eye puffiness, and mild fine lines and wrinkles. a total of 37 subjects were enrolled into the study.

this single center, open-label clinical study was conducted to evaluate the efficacy and tolerability of an eye cream on healthy female subjects between 35 to 60 years of age with fitzpatrick skin type i - vi, and moderate to severe dark circles and under-eye puffiness. this study aims to evaluate the following objectives: 1. to evaluate the eye cream impact on undereye dark circles, undereye puffiness, fine lines and wrinkles periorbital eye area, and overall appearance periorbital eye area, as evaluated by investigator clinical grading, chromameter, visia clinical photography, and subjective questionnaire performed at baseline, week 4, week 8, and week 12. 2. to evaluate the eye cream impact on under eye blood flow, as evaluated by laser doppler performed at baseline, week 8, and week 12. 3. to assess objective and subjective tolerability of dryness, erythema, and edema, and burning, stinging, peeling, and itching evaluated by investigator and subjective grading at baseline, week 4, week 8, and week 12. a total of 37 subjects completed the study.

Eligibility criteria:
inclusion criteria: * females in good general health * with fitzpatrick skin type i - vi * moderate to severe under eye dark circles * moderate undereye puffiness * mild to moderate fine lines and wrinkles exclusion criteria: * subjects who have used retinol or eye cream / serum 7 days prior to study commencement * nursing, pregnant, or planning a pregnancy during this study * having a health condition and / or pre-existing or dormant dermatologic disease on the face

Keywords: dark circles puffiness brightening
experimental study a.r.c.o. (cancer caregiver remote assistance)telehealth home medication vs/outpatient medication of central venous catheter picc (peripherally inserted central venous catheter)

Conditions: Infections

Summary: cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. the presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. the prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. this is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). the study is designed to evaluate that the complication rate recorded in the two groups are similar.


Eligibility criteria:
* share patient choice * availability at the patient's home at least once a week * availability during on line appointment time with the tutor/video