Kornimate/medical-research-clean huggingface dataset:
middle meningeal artery embolization with liquid embolic agent for treatment of chronic subdural hematoma

Conditions: Chronic Subdural Hematoma

Summary: the study evaluates the clinical and imaging outcome of middle meningeal artery (mma) embolization with liquid embolic agent for treatment of chronic subdural hematoma (csdh)

this study is a prospective one arm trial designed to assess the safety and efficacy of mma embolization with liquid embolic agents (onyx/squid/phil) as the main treatment of csdh. the subjects are enrolled in the study according to inclusion and exclusion criteria. imaging and clinical presentations of patients are recorded. within 48 hours of embolization, patients are assessed with clinical examination and with a brain ct scan to evaluate in any change in their symptoms and csdh volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for sdh volume change in ct scan and mri. if there is any significant increase in csdh volume or any deterioration of patient, evacuation of hematoma is considered. mma embolization is performed under general anesthesia using biplane or monoplane angiography. femoral or radial accesses are used. guiding catheter is advanced into external carotid artery in corresponding side. the corresponding mma is catheterized distally by micro-catheter and is embolized by liquid embolic agents. patients are discharge next day if they are stable.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed chronic or subacute subdural hematoma 2. patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ... 3. asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment exclusion criteria: 1. presentation with coma (gcs =\< 8) 2. patients needs emergent evacuation of hematoma, 3. patients could not participate in 60 days follow-up 4. pregnant patients 5. acute subdural hematoma 6. contraindication to contrast 7. contradiction to angiography 8. difficult access to mma due to anatomical variation 9. contraindication to liquid embolic agent 10. unmanaged/uncontrollable bleeding disorders

Keywords: chronic subdural hematoma embolization middle meningeal artery liquid embolic agent
cultural adaptation of emdr for major depressive disorder and compaire its online and face-to-face testing

Conditions: Major Depressive Disorder 1

Summary: the present study aims to develop a culturally and methodologically adapted emdr therapy protocol, determine its treatment fidelity, and then clinically test its efficacy in the treatment of major depressive disorder in pakistan by utilizing both in-person and online modalities of emdr therapy.

background and aim: major depressive disorder(mdd) is a globally leading cause of disability. currently, psychotherapies like eye movement desensitization and reprocessing(emdr) and cognitive behavioral therapy(cbt) are widely available. since emdr originated in the united states, it may not be completely appropriate for non-western countries like pakistan, necessitating possible modifications. moreover, therapists have long practiced face-to-face emdr, but recently, online emdr modalities have emerged. nonetheless, it is surprising that there is a dearth of research not only on adaptations of emdr in pakistan but also on testing its clinical efficacy, particularly its online modalities. considering this, the present study aims to develop a culturally and methodologically adapted emdr therapy protocol, and clinically evaluate its efficacy in treating mdd in pakistan by comparatively administering it through in-person and online modalities. methods: this study will employ a mixed mode randomized controlled trial design with a consecutive sample of (n=90). patients will be treated by using adapted emdr therapy protocol. patients will be randomly allocated to in-person and online modes of emdr. various qualitative methods and quantitative techniques will be employed to data. conclusion: this study is likely to make significant contributions by delivering insights about how to develop culturally and methodologically adapted emdr. this study will extend our knowledge about the comparative effectiveness of emdr in pakistan.

Eligibility criteria:
inclusion criteria: 1. the patient should exhibit symptoms of major depressive disorder. 2. male and female patients will be chosen equally. 3. patients between the ages of 20 and 50 will be selected. 4. patients should preferable be "treatment-naïve," meaning they have no recent history of any psychotherapy or medication. exclusion criteria: a. there must be no significant neuropsychological or cognitive disorders among the patients

Keywords: depressive disorder, major
test-retest reproducibility of 18f-dcfpyl pet/ct in the evaluation of patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: in this study, the investigators intend to validate 18f-dcfpyl test-retest reproducibility in metastatic lesions, in order to investigate whether it serves as a reliable response assessment tool, both to interpret existing studies and to design future longitudinal trials.

the investigators will image patients with widely metastatic castration-sensitive (cspc) or castration-resistant prostate cancer (crpc) using 18f-dcfpyl-pet/ct for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18f-dcfpyl-pet/ct follow-up scan, to assess test-retest reproducibility of this second-generation psma-targeted compound. second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * history of histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * patients with metastatic castration-sensitive (cspc) or castration-resistant prostate cancer (crpc) with evidence of metastatic disease on conventional imaging with ct or bone scan. * prior docetaxel-based chemotherapy is permitted * documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: rising psa over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases) * eastern cooperative oncology group (ecog) performance status of ≤ 2 exclusion criteria: * serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * administered a radioisotope ≤5 physical half-lives prior to the date of study pet/ct * administered iv x-ray contrast medium ≤24 hours prior to the date of study pet/ct * administered oral contrast medium ≤120 hours prior to the date of study pet/ct * condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Keywords: j18127 psma pyl 18f-dcfpyl pet/ct
risk factors for morbidity after parastomal hernia repair

Conditions: Parastomal Hernia

Summary: the danish ventral hernia database (dvhd) registers 37 different perioperative parameters. the aim of present study is to use large-scale data from dvhd to uncover risk factors for readmission, reoperation (any indication), death and reoperation for recurrence after parastomal hernia repair.

all principal parastomal hernias registered in the danish ventral hernia database are included in the study. the included patients will be followed in up to 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility criteria:
inclusion criteria: * all parastomal hernia repairs registered in the danish national ventral hernia database

Keywords: recurrence readmission reoperation mortality morbidity
electronic patient-reported outcome monitoring in aplastic anemia and paroxysmal nocturnal hemoglobinuria

Conditions: Aplastic Anemia; Paroxysmal Nocturnal Hemoglobinuria

Summary: aplastic anemia (aa) and paroxysmal nocturnal hemoglobinuria (pnh) are interrelated and very rare diseases. therefore, little data about clinical characteristics, especially the variety of symptoms in the course of the respective disease are available. as a consequence, patients may be left on their own between infrequent follow-ups at a specialist center. a web-based symptom-monitoring application can support selfmanagement and patient empowerment and promotes a patient- centered interdisciplinary team approach in the context of a "disease management program". this pilot study is to investigate usability and feasibility of the electronic patient-reported outcome (epro) application in aa/pnh by assessing recruitment, app utilization, data collection, functionality, acceptability after using and working with the epro application.


Eligibility criteria:
inclusion criteria: * aa (acquired and hereditary) and/or pnh patients * minimal level of computer literacy with prior email experience and access to an internet connection exclusion criteria: * mental alteration or psychiatric disease that can compromise written informed consent or adherence to the protocol and monitoring of the trial

Keywords: electronic patient-reported outcomes electronic health (ehealth) technology app utilization epro application
a study to evaluate pneumococcal polysaccharide vaccine effectiveness in children with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine if children with type 1 diabetes have adequate immune response to ppsv23 vaccination and to assess factors affecting immune response.


Eligibility criteria:
inclusion criteria: * children ages 3-18 years old. * clinical diagnosis of type 1 diabetes. exclusion criteria: * newly diagnosed with type 1 diabetes with in the past month of study date. * contraindications to receiving 23 valent pneumococcal vaccines. * other conditions associated with compromised immunity and vaccine response. * primary or secondary immune deficiency. * previous receipt of ppsv-23 vaccination.
patient preferences in anesthesia for abortion care

Conditions: Pregnancy Termination in First Trimester

Summary: this study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. we will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.

this study will utilize an open-ended semi-structured interview format to elicit a broader understanding of the multi-dimensional pain experience of woman undergoing an abortion procedure. this study seeks to provide further evaluation of the pain experience and preferences of women receiving alternative methods of pain management such as oral sedation and nitrous oxide. the study will use semi-structured interviews to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion and will include a procedural pain outcome using the visual analog scale (vas) to create a more patient centered experience.

Eligibility criteria:
inclusion criteria: * women undergoing first trimester surgical abortion choosing between oral anesthesia or nitrous oxide for pain management * women who are able to read and understand english * women who are 18 years old or older exclusion criteria: * under the age of 18 * women unable to consent and/or are cognitively impaired * women who are incarcerated * women who do not speak english

Keywords: pain management nitrous
study of choline chloride for injection in adolescent and adult patients with intestinal failure receiving long term parenteral support

Conditions: Choline Deficiency; Liver Injury

Summary: tara-001-301 is a phase 2b/3 randomized open-label dose-selection study with an open-label extension and randomized double-blind, placebo-controlled study with open-label extension to investigate the safety and efficacy of choline chloride for injection (low dose and high dose) versus placebo in adolescents (ages 12 to \< 18 years of age) and adults (≥ 18 years of age) with intestinal failure receiving long-term ps when oral or enteral nutrition is not possible, insufficient, or contraindicated. participants will be enrolled in one of 2 parts, each part will be followed by an open-label extension period of approximately a year. part 1: open-label dose-selection phase part 2: double-blind, placebo-controlled phase the purpose of the open-label dose-selection phase is to evaluate the safety, tolerability, how choline chloride for injection (study drug) is distributed in the body, and to select 2 of 3 doses for testing in the double-blind, placebo-controlled phase. the purpose of the double-blind, placebo-controlled phase is to assess the safety of the study drug and how well the study drug works at the 2 selected dose levels.


Eligibility criteria:
key inclusion criteria: * male or female 12 years of age or older at the time of signing the informed consent * individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry. * individuals with intestinal failure receiving long-term ps when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable ps at time of screening and for the duration of the study; note: long-term ps = participant must have been receiving ps for at least 6 months prior to screening and requiring ps at least 3 times per week * females of childbearing potential must have a negative urine pregnancy test at screening key exclusion criteria: * patients taking steatogenic medications for ≥ 12 weeks in the past 12 months; those taking any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to study entry * evidence of systemic active infection at the time of dosing * participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study * participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study * active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer) * clinically significant renal disease * low b12 or low serum folic acid levels that are less than the normal range * fulminant liver failure, with active bleeding and/or encephalopathy

Keywords: intestinal failure parenteral nutrition parenteral support choline chloride choline deficiency
group intervention in the nutritional profile, stress and quality of life in patients in cardiopulmonary rehabilitation

Conditions: Stress; Quality of Life; Nutritional Status

Summary: to evaluate the effectiveness of a group intervention in the nutritional profile, in the stress and in the quality of life of patients in cardiopulmonary rehabilitation. method: randomized clinical trial using a semi-structured interview, sociodemographic and anthropometric data collection, with 164 participants divided into a control group and intervention group, the food frequency questionnaire, the lipp adult stress symptom inventory (issl) ) and the sf-12 quality of life assessment questionnaire. to verify the difference in nutritional profile, stress levels and quality of life between the groups, the chi-square test will be used for categorical variables and within each group the comparison between the moments will be through the mc nemar test. in the quantitative variables the evaluation of the interaction between group and time will be through variance analysis using the design in repeated measures. considering a significance level p \<0.05. expected results: it is believed that psychological and nutritional intervention in patients participating in therapeutic groups helps them to elaborate questions regarding the difficulties of coping with the disease in the daily routine and to understand the importance of lifestyle care and healthy habits.


Eligibility criteria:
inclusion criteria: * cardiopathy patients over 18 years of age, users of the center for cardiopulmonary and metabolic rehabilitation of the cardiology institute who signed the term of free and informed consent exclusion criteria: * patients not able to respond to questionnaires at the time of application. patients who do not want to continue responding to the survey.

Keywords: cardiac rehabilitation psychology nutrition stress quality of life
tace/haic combined with lenvatinib and sintilimab in neoadjuvant therapy for intermediate-stage hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to observe the effect of tace/haic combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with hepatocellular carcinoma.

for patients with hepatocellular carcinoma staged bclc b/c(intermediate hepatocellular carcinoma)，tace is a widely used treatments .however ,the efficacy of tace in intermediate hepatocellular carcinoma is not very satisfactory.a series of study demonstrated that direct hepatectomy has better prognosis compared with tace for these intermediate hepatocellular carcinoma patients.despite of this ,the high recurrence risk, high probability of surgical complications, and poor treatment effect after recurrence of intermediate hepatocellular carcinoma after direct surgical treatment is a still a tough problem to be solved.recently, investigators have showed that hepatic arterial infusion of folfox-based chemotherapy (haic) was safe and efficient for advanced hcc patients. the combination of tace with haic (tace-haic) was proved to increase the local doses of chemotherapeutic agents in the liver .in addition, lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and programmed cell death protein-1 (pd-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma.in this context，for those patients with potentially high recurrence risk after liver resection, the investigators carried out this prospective randomized control to demonstrate the superiority of tace/haic combined with pd-1 antibody and lenvatinib as a neoadjuvant therapy before liver resection over direct hepatectomy.

Eligibility criteria:
inclusion criteria: * 1) age 18-70 years old, gender is not limited. * 2)the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl). * 3)patients must have at least one tumor lesion that can be accurately measured. * 4)conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein. * 5)according to the 2022 edition of the chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group * 6)no previous anti-hcc treatment. * 7)eastern co-operative group performance status 2 or less. * 8)liver function: child's a or b (score \< 7). exclusion criteria: * 1)patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava; * 2) allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs; * 3) local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months

Keywords: lenvatinib tace pd-1
long-term treatment study of certolizumab pegol without coadministration of methotrexate in japanese rheumatoid arthritis (ra) patients

Conditions: Rheumatoid Arthritis

Summary: the objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in japanese ra patients who transferred from study 275-08-003 (nct00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in american college of rheumatology 20% (acr20) responders who completed study 275-08-003.

this study was initiated by otsuka pharmaceutical co., ltd and transferred to astellas on 12/04/2012.

Eligibility criteria:
inclusion criteria: * subjects who participated in study 275-08-003 and meet all of the criteria described below. * patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24. exclusion criteria: * patients who experienced an important protocol deviation as mentioned below during study 275-08-003. * patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines). * patients who were found to have tuberculosis on a chest x-ray during study 275-08-003. * patients who required treatment for the same infection at two or more different times during study 275-08-003 * women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months. * patients whom the investigator has decided to be inappropriate for participation in the study

Keywords: rheumatoid arthritis certolizumab pegol cimzia