Kornimate/medical-research-clean huggingface dataset:
optimizing continuous-flow left ventricular assist device settings and identification of pump malfunction - a comparative study of echocardiography and invasive hemodynamics

Conditions: Heart Failure.

Summary: the purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (cf-lvad) settings. the hypothesis of the study is that pulmonary capillary wedge pressure (pcwp) will change independently of left ventricular end diastolic diameter (lvedd) when increasing pump speed ie δpcwp/rpm ≠ δlvedd/rpm. the primary combined endpoint of the study is correlation between δpcwp and lvedd slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.


Eligibility criteria:
inclusion criteria: * heart failure patients with heartmate ii (hm ii) followed as outpatients at the heart centre at university hospital of copenhagen, rigshospitalet. * age \> 18 years. * heart failure in stable phase without the need for intravenous inotropic therapy. * ischemic or non-ischemic cardiomyopathy. * signed informed consent. exclusion criteria: * unstable patients with the need for intravenous inotropic therapy. * current hospitalization. * implantation of hm ii less than one month ago.
safety and efficacy of cc-10004 for prurigo nodularis

Conditions: Prurigo Nodularis

Summary: this trial will include: * study period up to 7 months. * office visits monthly lasting approximately 1 hour. * blood draws. * oral medication that is taken 2 times daily. * photographs and biopsies if agreed.


Eligibility criteria:
inclusion criteria: * must understand and voluntarily sign an informed consent form * must be male or female and aged ≥ 18 years at time of consent * must be able to adhere to the study visit schedule and other protocol requirements * must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin d derivatives. * must meet the following laboratory criteria: * hemoglobin wnl * hematocrit wnl * white blood cell (wbc) count wnl * neutrophils ≥ 1500 /dl * platelets ≥ 100,000 /dl * serum creatinine ≤ 1.5 mg/dl * total bilirubin 2.0 mg/dl * aspartate transaminase (ast \[serum glutamic oxaloacetic transaminase, sgot\]) and alanine transaminase (alt \[serum glutamate pyruvic transaminase, sgpt\]) 1.5x upper limit of normal (uln) * females of childbearing potential (fcbp) must have a negative urine pregnancy test at screening (visit must have a negative purified protein derivative (ppd) within 28 days of the baseline visit. * must have a negative purified protein derivative (ppd) within 28 days of the baseline visit. exclusion criteria: * history of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator * any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration. * any topical treatments (including corticosteroids, vitamin d derivatives) within 14 days of study drug initiation. * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * pregnant or lactating female.

Keywords: pn
gb34 acupuncture in acute cholecystitis

Conditions: Acute Cholecystitis

Summary: the purpose of this pilot study is to investigate the effects of gb34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.

acute cholecystitis is a frequent complication of gallbladder stones. the prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. acute cholecystitis is one of the most frequently encountered acute surgical conditions. it is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain. although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. actually, timing of cholecystectomy was studied extensively, yet is still debatable. early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients. in fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. previously, studies demonstrating that gb34 has specific effects on the motility of bile ducts were published. more recently, researchers were able to demonstrate that gb34 electro acupuncture have positive effects on gall bladder wall thickness and on wbc levels, by using an experimental rabbit model of acute cholecystitis. additional functional mr studies were used to distinguish the neural specificity of the acupuncture points. gb34 were found to induce a specific response pattern which is more significant in motor functions in brain. furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.

Eligibility criteria:
inclusion criteria: * diagnosed and hospitalised patients with mild acute cholecystitis exclusion criteria: * pregnant women * immunosuppressive patients * patients with intermediate and severe acute cholecystitis * patients with acalculous acute cholecystitis * patients with uncontrolled diabetes mellitus * patients with collegen tissue diseases * patients with malignancies * patients who are using anti-coagulant or anti-aggregant medications * patients with blood diseases * patients with bmi\>35
phase i/ii study of heme arginate and tin mesoporphyrin for acute porphyria

Conditions: Porphyria

Summary: objectives: i. evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria. ii. evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of acute porphyria in up to 15 patients. iii. estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission. iv. evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

protocol outline: this project involves 4 studies: an unblinded multicenter treatment study, an unblinded prevention study, a controlled dose-ranging study, and a controlled drug combination dose-ranging study. in the treatment study, participants with acute attacks of porphyria receive intravenous heme arginate daily for 4 days. treatment may be extended to 7 days in patients with severe attacks and slow recovery; these data are analyzed separately. in the prevention study, participants receive weekly infusions of heme arginate for 6 months. treatment may be extended in selected cases; these data are analyzed separately. if an acute attack occurs, patients are treated with a standard course of heme arginate. participants are followed weekly for 6 months after preventive treatment. in the dose-ranging study, 4 groups of 3 patients are randomly assigned to standard and low-dose heme arginate infusions, administered daily for 4 days. after a washout of 4-12 weeks, patients are crossed to a second dose. in 2 of the 4 groups, patients cross between heme arginate and a normal saline control. in the combination dose-ranging study, 4 groups of 3 patients are randomly assigned to 1 of 2 doses of tin mesoporphyrin. after a 4-12 week washout, these patients are crossed to a standard or low-dose heme arginate infusion. after a second 4-12 week washout, patients are given a combination infusion of tin mesoporphyrin followed by heme arginate. all participants are given a special diet to prevent fluctuations in porphyrin precursors.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * well-documented acute porphyria, i.e.: acute intermittent porphyria variegate porphyria hereditary coproporphyria --patient characteristics-- * no pregnant women

Keywords: inborn errors of metabolism acute porphyria rare disease
sunvozertinib combined with chemotherapy for egfrm after egfr-tki treatment failure：phase i/ii

Conditions: Non Small Cell Lung Cancer

Summary: to access the anti-tumor efficacy, safety and tolerability of sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (nsclc) harboring epidermal growth factor receptor (egfr) sensitizing mutations who have progressed following standard tki therapy.

this study is a single arm study to access the anti-tumor efficacy, safety and tolerability of sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (nsclc) harboring epidermal growth factor receptor (egfr) sensitizing mutations who have progressed following standard tki therapy.

Eligibility criteria:
inclusion criteria: 1. to provide a signed and dated, written informed consent. 2. 80≥age ≥ 18 years old 3. histologically or cytologically confirmed non-squamous nsclc with documented egfr mutations from a local laboratory 4. egfr-sensitive mutations including exon 19 deletion and exon 21 l858r mutated, and exon 20 t790m mutated. 5. predicted life expectancy ≥ 12 weeks 6. egfr-tki resistance or intolerant to standard egfr tkis therapy. 7. no previous systemic chemotherapy for advanced or metastatic disease. 8. adequate organ system function: 9. patient must have measurable disease according to recist 1.1. 10. patients with stable or pre-treated brain metastasis (bm) can be enrolled exclusion criteria: 1. spinal cord compression or meningeal metastasis 2. a history of malignant tumors within 2 years. 3. with known resistant mutations that have approved target therapy 4. recover from aes caused by previous treatment 5. a history of stroke or intracranial hemorrhage within 6 months prior to initial dosing. 6. any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis b (hbv), hepatitis c (hcv), and human immunodeficiency (hiv)

Keywords: non small cell lung cancer sunvozertinib egfr chemotherapy
mesenchymal stem cells transplantation in patients with chronic renal failure due to polycystic kidney disease

Conditions: Chronic Renal Failure; Polycystic Kidney Disease

Summary: this study was designed to provide confirmation of safety of mesenchymal stem cells (mscs) therapy in chronic renal failure due to autosomal dominant polycystic kidney disease (adpkd).

the investigators will assess the 18-month safety and potential efficacy of autologous mscs as therapy for adpkd. a total of 6 patients with adpkd iv injection of high doses 2×106 of autologous mesenchymal stem cells / kg their weight, which will be derived from biopsies of their bone marrow. assessments will be made at 1, 3, 6, 12 and 18 months after cell injection. changes in gfr rate were evaluated by scan isotope.

Eligibility criteria:
inclusion criteria: * male and female * adpkd symptoms * adpkd confirmed with sonography and genetic testing * patient's age between 18 - 60 years * gfr gfr 25-60 ml/min/1.73 m2 * ability to understand and willingness to sign consent from exclusion criteria: * pregnancy or breastfeeding * associated cardiovascular disease * diabetes requiring medical intervention * other systemic diseases involving the kidneys, such as cancer, autoimmune diseases, blood diseases, liver disease, etc. * hospitalization due to illness in the last two months * life expectancy of less than two years * any allergies to the ingredients used in the cell culture

Keywords: autologous mesenchymal stem cells polycystic kidney disease intravenous injection crf
comparative study with photodynamic therapy and triamcinolone versus photodynamic therapy, triamcinolone and ranibizumab in patients with subfoveal choroidal neovascularization

Conditions: Subfoveal Choroidal Neovascularization

Summary: the purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin (pdt) and ivta vs triple therapy (tt) in patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd). the investigators designed a prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.

purpose: to compare the efficacy of photodynamic therapy with verteporfin (pdt) and ivta vs triple therapy (tt) in patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd). methods: prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. group 1: receive pdt followed by 4 mg ivta (n=7) or group 2: tt (triple therapy) pdt followed by 4 mg ivta + 0.5 mg ranibizumab (n=8).the main outcome measures were visual acuity (va), mean change in lesion size, mean change in foveal thickness, retreatment rate and the incidence and severity of adverse events. results: at 6 months 5 of 7 patients (71.4%) of group 1 and 8 of 8 patients (100% ) of group 2 had lost fewer than 15 letters (p\<.001). three patients (37.5%) of group 2 had an improvement of 3 lines or more. lesion type, patient age, and lesion size had no influence on the outcome, but baseline va had a statistically significant effect (p =.006). the median number of treatments in both groups was one. the 28% of pdt-triamcinolone group and 25% of triple therapy group had an increase in intraocular pressure (iop) that required therapy. progression or development of cataract was observed in 14.2 % in pdt- ivta group and 12.5% in triple therapy group. there were no cases of endophthalmitis. no cardiac or cerebrovascular accidents where presented. conclusions: the combination of pdt, intravitreal triamcinolone acetonide and intravitreal ranibizumab is a safe treatment option for neovascular amd and prevents a considerable decrease in va. in our patients it seems to be superior than combinated therapy with pdt and triamcinolone. clinical relevance: triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases. :

Eligibility criteria:
inclusion criteria: * subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) * any visual acuity exclusion criteria: * previous treatment * glaucoma

Keywords: age related macular degeneration
multisensory integration and pain perception

Conditions: Pain; Regulation, Self

Summary: pain is a predominant disruption of well-being among humans. feeling pain is a multimodal sensory experience where information is collected and processed from various senses such as sight and touch. because pain is complex, variable, and experienced differently by each individual, finding more accessible and practical treatments for pain are necessary. mindfulness meditation (mm) aims to reduce pain by directing focus to perceive thoughts through non-judgmental awareness. positive reappraisal (pr) is a possible cognitive pain treatment that focuses on changing the meaning of stressful or negative events into positive, benign, valuable, or beneficial. when a stressful event, such as experiencing pain, is positively reappraised, the individual recognizes and engages with the feeling of stress produced by the event and intentionally looks for benefits that change the feeling from negative to positive. the focus of this study is to examine the effect of different cognitive techniques on multimodal innocuous and noxious stimuli. visual and tactile noxious stimuli will be administered to determine how visual cue integrate to form and modulate the subjective experience of pain. the study team postulates that mindfulness meditation and positive reappraisal will significantly reduce pain in response to multimodal stimulus (visual cue + noxious heat) when compared to a non-manipulation control condition. these findings will be utilized to better understand the multidimensional mechanisms supporting nociception and the cognitive modulation of pain.


Eligibility criteria:
inclusion criteria: * native/fluent english speaker * ability to understand/willingness to sign consent form exclusion criteria: * chronic pain * cardiac medications * diagnosis of mental illness or personality disorder * diagnosis of heart or lung conditions/hyper tension * taking psychiatric medications

Keywords: multimodal pain perception regulation mindfulness
genetics of pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: despite the developments in recent years, pulmonary arterial hypertension (pah) is still a disease with high mortality and morbidity. although studies on genetic background have increased, the pathogenesis of pah remains complex and unresolved. the most comprehensive data are related to bone morphogenetic protein receptor type 2 (bmpr2), and in recent years, new responsible or candidate genes have been identified, especially by new generation dna sequencing in this study, it was aimed to determine the genetic background of patients with pah and to investigate the genetics of secondary pah not only hpah.

in our study, changes in bmpr2, sars2, krt8, krt18, smad9, cav1, kckn3, cps1, tbx4, acvrl1, g6pc3, eif2ak4 and eng genes will be screened in patients with pah. in addition to previously reported changes in the relevant genes, previously unreported changes that are likely to be significant according to insilico methods are presented. patients' age, gender, mean follow-up time, underlying congenital heart anomalies, 6-minute walk test (6 mwt), probnp, catheter measurement values (mpab, m rab, rp/rs, pvr), vasoreactivity test positivity, world health organization functional classification (who-fs), cardiac function measurements by echocardiography, treatments they received will be collected retrospectively.

Eligibility criteria:
inclusion criteria: * mpab ≥25 mmhg, pulmonary capillary wedge pressure (pcwp) ≤15 mmhg, pvr index (pvri) ≥3 wu.m2 in right heart catheterization. exclusion criteria: * neonatal pulmonary hypertension

Keywords: genetics pulmonary hypertension
peripheral venous pressure variation, pulse pressure variation and pleth variability index for fluid responsiveness

Conditions: Pulse Pressure Variation; Stroke Volume Variation; Pleth Variability Index

Summary: pulse pressure variation (ppv) and pleth variability index (pvi) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. ppv, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and pvi, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. in this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. in addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the ppv and pvi.

pulse pressure variation (ppv) and pleth variability index (pvi) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. the investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.

Eligibility criteria:
inclusion criteria: * patients voluntarily agreed and signed the written informed consent form before participating in the study * adults aged 19 years or older * american society of anesthesiologists physical class (asa) 1-3 * patients scheduled for elective hepatectomy under general anesthesia * patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation * non-smokers with normal pulmonary function exclusion criteria: * patients with abnormal findings on electrocardiogram before surgery * patients who cannot undergo peripheral venous puncture
addition of popliteal plexus block to continuous femoral nerve block for total knee arthroplasty

Conditions: Pain, Postoperative

Summary: the popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. it consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. however, the analgesic efficacy has never been demonstrated in a randomized controlled trial. therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block. the continuous femoral nerve block will be performed by the anesthesiologist with 15 mls of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. the popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia. postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of ropivacaine 0.2%.

Eligibility criteria:
inclusion criteria: * patients scheduled for total knee athroplasty under general anesthesia * asa 1-3 exclusion criteria: * kidney disease with gfr \< 50 ml/mn * daily opioid consumption \> 1 month * allergy to local anesthetics * neurological problems of the lower extremity * other contraindications to peripheral nerve blocks