Kornimate/medical-research-clean huggingface dataset:
study of the safety and efficacy of miw815 with pdr001 in patients with advanced/metastatic solid tumors or lymphomas

Conditions: Solid Tumors and Lymphomas

Summary: the purpose of this study was to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of miw815 (adu-s100) in combination with pdr001.

this was a phase ib, multi-center, open-label study to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of miw815(adu-s100) in combination with the pd-1 checkpoint inhibitor pdr001. two different schedules were explored in two dose escalation groups in accessible cutaneous or subcutaneous lesions. the optional dose confirmation group exploring intratumoral injection of viscerally located lesions was not opened due to the program's early termination. group a included patients with accessible solid tumors and lymphomas. this group received a fixed dose of pdr001 i.v. on day 1 of every 28 day cycle and intratumoral injections of miw815 (adu-s100) on days 1, 8 and 15 of every 28 day cycle. group b included patients with accessible solid tumors and lymphomas. this group received a fixed dose of pdr001 i.v. on day 1 of every 28 day cycle and an intratumoral injection of miw815 (adu-s100) on day 1 of every 28 day cycle. once the dose and dose schedule had been confirmed, the plan was to open the dose expansion part of the study. however, the expansion phase of the study was not opened to enrollment due to the program's early termination.

Eligibility criteria:
inclusion criteria: ecog ≤ 1 willing to undergo tumor biopsies from injected and distal lesions must have two biopsy accessible lesions: exclusion criteria: symptomatic or untreated leptomeningeal disease. presence of symptomatic central nervous system metastases impaired cardiac function or clinically significant cardiac disease active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. active infection requiring systemic antibiotic therapy. known history of human immunodeficiency virus infection. active epstein-barr virus, hepatitis b virus or hepatitis c virus malignant disease, other than that being treated in this study

Keywords: injected lesion distal lesion abscopal activity intratumoral checkpoint inhibitor cyclic dinucleotide programmed cell death
the pci choice trial: a pilot randomized trial of a decision aid for patients with stable coronary artery disease

Conditions: Stable Angina

Summary: despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - pci) does not prolong survival or prevent myocardial infarction (mi) for stable coronary artery disease (cad), patients with stable angina continue to believe that pci is performed to improve these outcomes. additionally, recent concerns have emerged of overuse of pci among patients with little or no angina. thus there is a compelling need to share with patients the risks and benefits of pci prior to treatment to reach an informed decision. this study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.


Eligibility criteria:
inclusion criteria: * diagnosis of stable angina - as judge by clinician, eligible for medication therapy or pci - agree to be available for follow-up survey 3 months after treatment decision exclusion criteria: * has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in english)
qlesp block versus periarticular infiltration for postoperative analgesia in hip surgery

Conditions: Regional Anaesthesia

Summary: local and/or regional analgesia techniques are critical components of an optimal multimodal analgesia technique, as they have been shown to improve pain relief as well as reduce opioid requirements. optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. periarticular infiltration (pai) is increasingly included as a component of multimodal analgesia technique for patients undergoing tha, as it provides improved postoperative pain relief with no effects on quadriceps function. recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (qlesp) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. therefore, we designed a randomized controlled trial to compare ultrasound-guided qlesp with pai as a component of non-opioid analgesic regimen in patients undergoing tha via posterior approach. we hypothesized that qlesp would provide superior analgesia when compared with pai. the primary outcome of the study was postoperative opioid requirements within the initial 24-h postoperative period after tha. the secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.


Eligibility criteria:
inclusion criteria: 1. age 18-65 yrs 2. american society of anesthesiologists classification 1-3 3. body mass index between 20 and 35 (kg/m2) 4. undergo elective primary unilateral tha via a posterolateral approach 5. informed consent exclusion criteria: 1. a known allergy to the drugs being used 2. pre-existing neuropsychiatric disorders or language barrier 3. analgesics intake, history of substance abuse 4. contraindications to peripheral nerve block 5. acute cerebrovascular disease 6. severe liver failure
the effect of ear plug and eye mask on sleeping quality in critically ill patients

Conditions: Sleep

Summary: sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. critically ill patients experience poor sleep quality. surveys of icu survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the icu stay. many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the icu patients. the primary physiologic factors documented in the literature are pain, medications and illness.the primary psychological factors documented in the literature are stress and worry. environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in icu patients.

50 patients in the age range 18- 60 years admitted to icu of assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Eligibility criteria:
inclusion criteria: * age \>18 years old. * mechanically ventilated patient. * conscious patient. * no hearing problems. * no eye disease. * not receiving narcotic drugs five to six hours before sleep time at night. * no underlying disease that is affecting sleep such as rheumatoid arthritis and migraine. exclusion criteria * head injury. * psychiatric disease. * shocked patients

Keywords: delirium ear plug eye mask mechanical ventilation sleep
phase iii study comparing the efficacy and safety of la-ep2006 and peg-filgrastim

Conditions: Chemotherapy-induced Neutropenia; Breast Cancer

Summary: the study will assess the efficacy of la-ep2006 compared to neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

the pegfilgrastim randomized oncology (supportive care) trial to evaluate comparative treatment (protect-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar la-ep2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. patient received tac (intravenous docetaxel 75mg/m\^2, doxorubicin 50 mg/m\^2, and cyclophosphamide 500mg/m\^2) on day1 of each cycle, for six or more cycles. a total of 308 patients were randomized to la-ep2006 (n=155) or reference neulasta® (n=153). treatment was given subcutaneously on day 2 of each cycle. the primary end point was the duration of severe neutropenia (dsn) during cycle 1 (defined as number of consecutive days with absolute neutrophil count \<0.5 × 10\^9 cells/l). la-ep2006 was equivalent to the reference product in dsn (difference: -0.16 days; 95% ci \[-0.40, 0.08\]). further, la-ep2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety.

Eligibility criteria:
inclusion criteria: * histologically proven breast cancer * eligible for six cycles of neoadjuvant or adjuvant chemotherapy exclusion criteria: * concurrent or prior chemotherapy for breast cancer * concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy * concurrent prophylactic antibiotics * previous therapy with any g-csf (granulocyte-colony stimulating factor) product other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pegfilgrastim g-csf neutropenia breast cancer myelosuppressive chemotherapy
study to assess safety and quality of life of patients using biojector versus needles for fuzeon administration

Conditions: Human Immunodeficiency Virus

Summary: hypothesis: patients using enfuvirtide with the biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

this study is a "n of one" trial where the patient is their own control. we will provide the quality of life questionnaire, the mos-hiv questionnaire; isr questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. as well, demographics and laboratory data will be collected. the same procedures will be given 1 month after the use of biojector in a follow-up visit.

Eligibility criteria:
inclusion criteria: patients who have taken enfuvirtide for at least one month exclusion criteria: patients with hemophilia

Keywords: injection site reactions enfuvirtide administration
dietary treatment of hyperlipidemia in women vs. men

Conditions: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia

Summary: to conduct a dietary intervention trial to test the lipid lowering response to the national cholesterol education program (ncep) step two diet by free-living hyperlipidemic women and men and to compare the response between them.

background: women experience as much illness from hardening of the arteries including stroke and heart disease as do men, but because women experience them later in life, the importance of heart disease, cholesterol, and diet for women has been under appreciated. design narrative: half of the subjects were randomized to diet instruction with two years of follow-up and half to six months of no intervention followed by the same diet instruction and followup. control subjects had a fasting blood drawn at three months of the nonintervention period. having parallel intervention and control groups was necessary to test the efficacy of the ncep step two diet: the diet was taught to study subjects during eight weekly two hour classes. follow-up included four individual visits, at three, six, nine, and twelve months, with a dietitian and two group sessions, at 4.5 and 10.5 months, in the first year and two individual visits, at 18 and 24 months, in the second year. fasting blood samples for lipoprotein lipid analysis and 4-day food diaries were collected at all individual visits. additionally, medical history, lifestyle characteristics, vital signs, other adherence measures, behavioral factors related to adherence, and serum nutrients for monitoring nutrient sufficiency were collected. dietitians provided adherence and dietary modification counseling as necessary to help participants maximize their adherence. the primary questions to be answered were: 1) did the ncep step two diet effectively lower plasma lipids in hypercholesterolemic (hc) and combined hyperlipidemic (chl) women and men over six months? 2) did hc and chl women have a different response than hc and chl men? 3) was response in women influenced by menstrual status and sex hormone exposure?, and 4) were the behavioral adaptations to dietary modification different between women and men?

Eligibility criteria:
no eligibility criteria
computed tomography angiography prediction score for side branch occlusion

Conditions: Coronary Artery Disease

Summary: lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (pci). revascularization within bifurcation sites remains technically challenging. while the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (sb) occlusion is one of the most serious procedural complications with prevalence rates over 7%. numerous mechanisms of the sb occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. regardless of the cause, loss of the sb is associated with increased risk of periprocedural mortality and myocardial infarction. therefore, pci involving coronary bifurcation mandates consideration of the risk of sb compromise. the ct-precision (computed tomography angiography prediction score for side branch occlusion in coronary bifurcation intervention) registry was designed to evaluate the application of coronary computed tomography angiography (coronary cta) for the prediction of sb occlusion during percutaneous revascularization of bifurcation lesions. the main purpose of this single-center study is to develop a noninvasive cta-based prediction tool to determine the procedural outcome of pci in bifurcation lesions.

coronary cta allows for precise and noninvasive evaluation of coronary bifurcation lesions. pre-procedural planning for coronary revascularization using cta provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. to date there has been no compiled cta-based prediction model for sb occlusion in coronary bifurcation intervention. the ct-precision registry is a retrospective observational cohort study of patients undergoing preprocedural coronary cta before pci involving coronary bifurcation lesions between january 2010 and july 2018. the study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the sb at a single high-volume pci center.

Eligibility criteria:
inclusion criteria: * patients referred for attempted pci of a bifurcation lesion with a significant sb as part of their standard of care * initial stenting of the main branch with a provisional approach to the sb * performance of dual-source coronary cta within 30 days before attempted pci exclusion criteria: * age \<18 years

Keywords: coronary artery disease coronary bifurcation lesion coronary angiography coronary computed tomography angiography percutaneous coronary intervention
β-hydroxy-β-methylbutyrate-enriched nutritional supplements for obesity adults

Conditions: Obesity

Summary: the purpose of this study is to assess the effectiveness and safety of hmb-enriched nutritional supplements for improving muscle mass and muscle function in chinese adults with obesity during the weight loss process using calorie restriction.


Eligibility criteria:
inclusion criteria: 1. men and women aged 30-50 years 2. currently having obesity defined by body mass index (bmi) ≥ 28 kg/m2 (based on measured body weight and height at booking, using validated scales) 3. having an intention to lost weight via caloric restriction 4. apparently healthy and able to walk independently 5. able to eat independently to meet their energy needs 6. without significant body weight change in the last 6 month (less than 5% change in body weight) 7. having sedentary habit defined by sedentary behavior research network 8. able to collaborate with the research staff. exclusion criteria: 1. having a history of intolerance to enteral nutrition, food (e.g., lactose intolerance), or being allergic to the components of our hmb-enriched nutritional supplements (e.g., soy or corn); 2. having any implants (e.g., pacemakers); 3. current use of other nutritional supplements or drugs that may have an impact on the effectiveness of the intervention (e.g., glucocorticoids, antineoplastic drugs, antituberculosis drugs, sedatives, antipsychotics, muscle relaxants, monoamine oxidase inhibitors, antibiotics) within 3 months prior to enrollment; 4. secondary obesity caused by diseases (e.g., hypothalamic diseases and hypercortisolism) or drugs (e.g. glucocorticoids, insulin, tricyclic antidepressants); 5. clinically visible edema; 6. trauma, surgery, hospitalization, fall, or fracture within 6 months prior to enrollment; 7. pregnancy, having pregnancy plans, or lactation; 8. individuals who are participating in other clinical trials; any acute illness (e.g., acute infection, myocardial infarction, arrhythmia, myocarditis, appendicitis, etc.); 9. swallowing disorders; abnormal thyroid function (including hyperthyroidism and hypothyroidism); 10. having a history of diabetes, respiratory diseases, cardiovascular diseases, uncontrolled hypertension, kidney diseases, digestive system diseases, renal insufficiency, mental illness, neurological diseases, hematologic diseases, liver diseases (except for fatty liver), chronic infection (e.g., tuberculosis), immune system diseases, joint disorders, any type of tumor; 11. alcohol consumption over two standard alcoholic beverages (20 g of alcohol/day); 12. difficulty to comply with the study protocol; 13. other conditions that indicate the individuals are inappropriate for participation in this study.
the paclitaxel-eluting percutaneous transluminal coronary angioplasty (ptca) - balloon catheter in coronary artery disease to treat chronic total occlusions

Conditions: Coronary Artery Disease; Chronic Total Occlusion; Native Coronary Artery

Summary: the aim of the study is to assess the safety and efficacy of a paclitaxel-eluting ptca-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.


Eligibility criteria:
inclusion criteria: * chronic total occlusion * thrombolysis in myocardial infarction (timi) flow 0 or 1 * occlusion in native coronary artery * indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia * reference diameter 2.5 mm to 4.0 mm exclusion criteria: * saphenous vein graft * bifurcation lesion with need to stent main and side branch * left main occlusion * de-novo stenosis (no occlusion) * restenosis * in-stent restenosis * contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months * coronary aneurysm at target lesion
a study to evaluate the efficacy, safety, and pharmacokinetics (pk) of ro7837195 in participants with moderately to severely active ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy of ro7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and/or advanced therapies has failed.

this study consists of up to 5-week screening period, a 12-week induction phase, a 40-week active treatment extension, and a safety follow-up period following the last dose of study treatment. the induction phase will be placebo-controlled and after its completion, all participants will receive treatment with active study drug, regardless of the treatment response.

Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis (uc) established at least 3 months * moderately to severely active uc assessed by mms * inadequate response, loss of response, or intolerance to conventional or advanced therapies for uc exclusion criteria: * prior extensive colonic resection, subtotal or total colectomy, or planned surgery for uc * diagnosis of crohn's disease or indeterminate colitis * treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1a (tl1a) * inadequate response, loss of response, or intolerance to treatment of uc with an advanced therapy targeted at il-12 and/or il-23
body position and ultrasound examination of the gastric antrum

Conditions: Pulmonary Aspiration of Gastric Contents

Summary: pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. in particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. this score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. however, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. this study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.


Eligibility criteria:
inclusion criteria: * adults 18 years old or older * last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study * informed consent must have been signed. * no significant medical history (american society of anesthesiologists (asa) class 1) exclusion criteria: * adult unable to give informed consent * previous gastrointestinal surgery * medication affecting gastric motility * digestive diseases, gastroparesis, diabetes mellitus with insulin * pregnancy or breastfeeding * obesity (body mass index (bmi) ≥ 30 kilograms/meter² (kg/m²))