Kornimate/medical-research-clean huggingface dataset:
a comparison of inhalation vs. intravenous induction

Conditions: Hypothermia

Summary: to compart differences on the effect on core temperature between anesthetic induction with intravenous propofol versus inhalation induction with sevoflurane

hypothermia occurs with anesthetic induction due to redistribution hypothermia. hypothermia has adverse effects and should be avoided or minimized. intravenous propofol induction is the most common technique used for anesthetic induction. there is preliminary evidence that there is less redistribution hypothermia when anesthetic induction is achieved by inhalation induction compared to intravenous induction. there is not enough data to compel a change in practice patterns. this study will enroll a larger number of patients in order to provide stronger evidence that there is a significant difference between induction techniques on body temperature. patients will be randomly assigned to two variation of inhalation induction techniques and two variations of intravenous induction. the effect on temperature between the four groups will be compared. reducing the degree of hypothermia has the potential to decrease surgical infection rate as well as providing other benefits to patients.

Eligibility criteria:
inclusion criteria: elective surgery adult, age \>= 18 years old scheduled for general anesthesia medically fit and able to safely go any of the four anesthetic inductions in the study exclusion criteria: emergency surgery, or any other aspiration risk minor, age \<18 pregnant febrile illness contraindication to nasal instrumentation allergy to propofol malignant hyperthermia requiring total invravenous anesthesia (tiva) inability to oxygenate on less than 50% fio2 intra-cranial surgery receiving vasoactive medications significant valvular heart disease unstable cardiac disease surgery requiring prone or lateral positioning contraindication to nitrous oxide prisoners
real world evidence of the effectiveness of paritaprevir/r - ombitasvir, ± dasabuvir, ± ribavirin in patients with chronic hepatitis c - an observational study in hungary

Conditions: Chronic Hepatitis C

Summary: the study seeks to provide evidence of the effectiveness and obtain patient reported outcome (pro), work productivity and safety data of the interferon-free regimen of paritaprevir (ptv)/ritonavir (r) + ombitasvir (obv), ± dasabuvir (dsv), ± ribavirin in chronic hepatitis c virus infected participants.


Eligibility criteria:
inclusion criteria: * treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis c (chc), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (ptv)/ritonavir (r) + ombitasvir (obv), ± dasabuvir (dsv), ± ribavirin (ptv/r+obv±dsv±rbv) according to standard of care and in line with the current local label. * if rbv is co-administered with the ptv/r+obv±dsv±rbv, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy). * patients must voluntarily sign and date subject information form and informed consent form prior to inclusion into the study. * patient must not be participating or intending to participate in a concurrent interventional therapeutic trial. * patient has been started on ptv/r+obv±dsv±rbv therapy no more than one (1) month prior to the study enrollment. exclusion criteria: • none

Keywords: chronic hepatitis c dasabuvir paritaprevir/r/ombitasvir observational study quality of life fibrosis cirrhosis work ability
anti-gd2 adc m3554 in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of m3554 in participants with soft tissue sarcoma (sts) and glioblastoma, idh-wildtype. study details include: study duration per participant: approximately 4 months


Eligibility criteria:
inclusion criteria: * escalation a: participants with documented histopathological diagnosis of locally advanced or metastatic sts with unresectable disease that has progressed after at least one prior line of systemic therapy for the metastatic setting including anthracyclines. previous trabectidin, eribulin, pazopanib or any other drug approved for the different sts subtypes in second line (2l) or beyond will not be required for enrollment but will be allowed (for example \[e.g\] trabectedin, pazopanib for leiomyosarcoma (lms); ifosfamide, gemcitabine-based combinations, trabectedin, eribulin, pazopanib for liposarcoma (lps); trabectedin, gemcitabine, and docetaxel, pazopanib for undifferentiated pleomorphic sarcoma \[ups\]). participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention. * escalation b: participants with documented histopathological diagnosis of glioblastoma, idh-wildtype, who have progressed after only one prior line of therapy (including radiotherapy +/- temozolomide, depending on the o\^6-methylguanine-dna methyltransferase \[mgmt\] status) and relapsing at least 3 months after the end of the radiotherapy treatment. * eastern cooperative oncology group performance status (ecog ps) below or equal to 1 * participants with adequate hematologic, hepatic and renal function as defined in protocol * other protocol defined inclusion criteria could apply * exclusion criteria: * participant has a history of malignancy other than sts or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 3 years). * sts only: participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression * other protocol defined exclusion criteria could apply

Keywords: glioblastoma idh-wildtype soft tissue sarcomas gd2 prevalence targeted therapy top1 inhibitor exatecan
nutritional intervention in malnourished elderly patients

Conditions: Malnutrition

Summary: the purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.

malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and adl function (activities of daily living). malnourished medical inpatients/outpatients and district nurse patients with a body mass index \< 20 kg/m2 are asked to participate. comparison(s): the patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. the study supplementation is fresubin protein energy drink and this will give additional 600 kcal and 40 gram protein a day. the study period is 12 weeks with a visit at inclusion, week 6 and week 12. primary and secondary outcome parameters are measured at inclusion and week 12

Eligibility criteria:
inclusion criteria: * body mass index \< 20 kg/m2 * medical in/outpatient or district nurse-patient * able to take nutritional supplement (sip feeding) * able to walk * written patient informed consent exclusion criteria: * actual malignancy * dementia with a mini mental status score \< 24 * severe depression * need for total parenteral nutrition or tube feeding * prescribed nutritional supplements during more than the last week * life expectancy of less than 6 months

Keywords: function elderly adl nutritional supplementation quality of life handgrip strength body composition
nerve injury in the hand, an interview study

Conditions: Nerve Injury

Summary: this qualitative study sought to explore the exerience of change in physical activity due to nerve injury in the arm and hand.

aim: has the physical activity level changed in connection with the nerve injury. experiences of factors influensing this change. population: patients surgically treated for digital,median,ulnar-or plexus nerveinjuries at södersjukhuset or universitets sjukhuset in linköping. 1-3 years ago. age 18-75. method: interviews are carried out over the phone, digitally recorded and trascribed. the analysis is inductive approach.

Eligibility criteria:
inclusion criteria: * injury to the median, ulnar or digital nerve or injury to the brachial plexus. * 1-5 years post injury. exclusion criteria: * severe psychiatric disease. * drug or alcohol abuse. * insufficient language understanding. * severe diabetes mellitus with nerve complications.
written vs electronic safety planning study

Conditions: Suicidal Ideation; Suicide Attempt; Mental Health

Summary: safety planning is a brief, ed-feasible intervention which has been demonstrated to save lives and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. in one popular version of the safety plan developed by stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means. this study aims to find out how valuable an electronic safety plan is compared to a traditional paper safety plan. people who are visiting the emergency department for thoughts of self-harm will be asked to participate.

this project has 3 aims: (1) will ed patients with suicidal ideation/attempt accept coaching on safety planning from non-clinical personnel (i.e., medical students or peer supporters); (2) are these safety plans of high-enough quality for clinical personnel; and finally, (3) will ed patients with suicidal ideation/attempt complete safety plans electronically?

Eligibility criteria:
inclusion criteria: * patients presenting for suicidal ideation (si) or after a suicide attempt to the uams ed * willingness to engage in safety planning with trained non-clinical staff * have not already filled out a safety plan at the current visit exclusion criteria: * \ 89 years of age * incarcerated or in police custody * non-english-speaking or non-english-writing (as translators will not be available for this study) * critically-ill (or appear to be critically-ill) * intoxicated with alcohol or other substance(s) * ed staff objection to patient enrollment in study * unwilling or unable to complete the safety plan electronically * unwilling or unable to use a tablet device to complete the safety plan * unwilling or unable to show/email the safety plan to clinical and research staff

Keywords: suicide suicide prevention safety planning safety net app
study of ll-bmt1 in patients with elevated intraocular pressure

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: this is an open-label, phase 2a clinical study of ll-bmt1 in patients with primary open-angle glaucoma and ocular hypertension. study subjects will be treated for 7 days with a single dose of ll-bmt1.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age at the screening visit * diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes * at least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmhg and 34 mmhg (inclusive) as measured at 9 am during the baseline visit. * best corrected visual acuity of early treatment diabetic retinopathy study of 50 letters or better exclusion criteria: * glaucoma or optic neuropathy due to anything other than above noted reasons cup-to-disc ratio of \>0.8 in either eye * corneal thickness \ 620 μm

Keywords: glaucoma prostaglandin intraocular pressure
mk0524 seasonal allergic rhinitis study (0524-005)(completed)

Conditions: Seasonal Allergies

Summary: to assess the efficacy of mk0524 on seasonal allergies.


Eligibility criteria:
inclusion criteria: * person has had at least 2 years of seasonal allergies * person has had a positive skin test to at least 1 of the allergens of the season * person is a non-smoker exclusion criteria: * person has been hospitalized within the last 4 weeks * person is a female who has had a baby within the last 8 weeks or is still breast-feeding
real-world elecsys® gaad implementation and validation to improve surveillance and early detection of hcc

Conditions: Liver Cirrhosis; Hepatocellular Carcinoma

Summary: patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (hcc) which implies significant mortality. at present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death. the goal of this study is to implement elecsys® gaad in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis. the main questions it aims to answer are: * does the introduction of the elecsys® gaad algorithm to the surveillance pathway increase early detection of hcc? * does the introduction of the elecsys® gaad algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations? * does the new surveillance pathway improve adherence? researchers will compare elecsys® gaad with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.


Eligibility criteria:
inclusion criteria: • patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance exclusion criteria: * pregnancy/breast-feeding. * patients who do not have liver cirrhosis * patients who already have hepatocellular carcinoma * any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. the investigators will use every opportunity, including tele-interpretation services to minimise this from happening.

Keywords: gaad hepatocellular carcinoma cirrhosis health inequalities surveillance
a prospective study of free-hand transperineal image fusion targeted biopsies under local anesthesia

Conditions: Prostate Neoplasm

Summary: this trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.

12-core transrectal ultrasound (trus) biopsy is one of the most performed urological procedures and remains the standard method for prostate cancer (pca) histological diagnosis according to the most recent guidelines. during the last decade, the transperineal prostate biopsy has attracted renewed interest. however, only a few studies and no large prospective studies investigated complications of the transperineal approaches. image fusion of multi-parameter mri (mpmri) and trus guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. combination of targeted and standard biopsy was recommended in recent guidelines. image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia. the scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. in this study, the investigators will additionally assess the functional results of erectile function and urinary function. together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. then, feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.

Eligibility criteria:
inclusion criteria: * men more than 18 years old with clinical suspicion of prostate cancer; * serum psa ≤ 20 ng/ml within the previous 3 months; * suspected stage ≤ t2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; * no evidence of psa increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; * able to provide written informed consent. exclusion criteria: * prior prostate biopsy or prostate surgery; * prior treatment for prostate cancer; * contraindication to mri (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); * contraindication to prostate biopsy.
the energy conservation education intervention

Conditions: Fatigue; End Stage Kidney Disease; Quality of Life

Summary: fatigue is the most common symptom reported by 70 - 85 % of people with end-stage kidney disease (eskd) receiving haemodialysis (hd). educational interventions involving energy conservation strategies are helpful in reducing fatigue. however, the effectiveness of energy conservation has not been previously studied in people with eskd receiving hd. this study aims to develop and evaluate the effectiveness of energy conservation education intervention for people with end-stage kidney disease receiving haemodialysis (everest) in nepal. symptom management theory (smt) will guide this study. a pragmatic cluster randomised controlled trial (pcrt) will be conducted in one dialysis centre in nepal. people on hd who meet the eligibility criteria will be invited to participate. the primary outcome is fatigue severity and the secondary outcome are other renal symptoms, occupational performance and health-related quality of life. intention to treat analysis will occur and will include a change in the primary and secondary outcome. the study will provide evidence about the feasibility and effectiveness of everest for symptom management.


Eligibility criteria:
inclusion criteria: participants diagnosed with eskd and undergoing haemodialysis for ≥ 3 months, aged 18 years and above, able to speak and understand nepali language and willing to participate will be included in this study. exclusion criteria: participants who are in the early stage of ckd or not dependent on hd, those acutely ill, diagnosed with cognitive impairment and those who are not willing to participate will be excluded.

Keywords: end-stage kidney disease, fatigue, haemodialysis, quality of life
a study to develop predictive and prognostic tools for optimizing therapy with bevacizumab frontline cancer therapy in participants with her 2-negative aggressive metastatic breast cancer

Conditions: Breast Cancer

Summary: this multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.


Eligibility criteria:
inclusion criteria: * participants with her2-negative metastatic breast cancer. mandatory to have the her2/estrogen receptor (er)/progesterone receptor (pr) status * participant who met criteria for first-line treatment with chemotherapy plus bevacizumab (standard doses) by local, regional or national guidelines or authorities * participants with measurable disease (recist criteria v1.1) or participants with no measurable but assessable disease * molecular phenotype as triple negative metastatic breast cancer; and er-positive tumors need to fulfill at least one of the two clinical criteria: metastatic relapse on adjuvant endocrine therapy or progression to at least one prior line of endocrine therapy for advanced disease; or aggressive disease criteria (at least two criteria): taxane based regimen in the (neo) adjuvant setting; metastatic relapse within 2 years from the end of chemotherapy for early breast cancer; liver metastasis; three or more organs with metastatic involvement; symptomatic visceral disease * eastern cooperative oncology group (ecog) 0-2 exclusion criteria: * participant has received prior chemotherapy for metastatic disease * participant requiring major/minor surgery within 3 weeks prior to administration of the first dose of study treatment * participant has received an investigational therapy within 4 weeks prior to study entry * participant has known symptomatic brain metastases * participant with non-measurable or assessable disease: exclusive blastic bone disease; pleural, pericardial or abdominal effusion as only evidence of disease * participant in chronic daily treatment with corticosteroids (doses greater than \[\>\]10 milligrams per day \[mg/day\] of methylprednisolone or equivalent), except inhaled steroids * pregnant or breastfeeding participant * women of childbearing potential who are not using hormonal contraceptives or highly effective birth control during the study * participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * participant with significant renal, hematological or liver function alteration according to investigator's criteria * participant has serious medical risk factors involving any of the major organ systems
a study to assess usability of risankizumab autoinjector combination product in participants with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the objectives of this study were to evaluate the usability of the combination product of risankizumab in an autoinjector (ai), as well as to evaluate the efficacy, safety, and tolerability of risankizumab administered by ai for the treatment of adult participants with moderate to severe plaque psoriasis.

this was a phase 3 multicenter, single-arm, open-label study that evaluated usability and efficacy of the risankizumab-ai combination product. the study included a 30-day screening period with study visits at weeks 0, 4, 16, 28, and 40 with a subsequent follow-up telephone call at approximately 20 weeks after the last dose of study drug (week 48). study drug dosing consisted of 4 self-administered doses given subcutaneously on weeks 0, 4, 16, and 28. dosing on weeks 4 and 16 was self-administered at home.

Eligibility criteria:
inclusion criteria: * participant has diagnosis of chronic plaque psoriasis for at least 6 months before the baseline visit * participant meets following disease activity criteria: * stable moderate to severe chronic plaque psoriasis, defined as ≥ 10% body surface area (bsa) psoriasis involvement, static physician global assessment (spga) score ≥ 3, and psoriasis area severity index (pasi) ≥ 12 at screening and baseline visit * candidate for systemic therapy as assessed by the investigator exclusion criteria: * participant has history of active skin disease other than psoriasis that could interfere with the assessment of psoriasis * participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis * participant has previous exposure to risankizumab

Keywords: psoriasis risankizumab plaque psoriasis