Kornimate/medical-research-clean huggingface dataset:
the effect of dexamethasone on rebound pain in patients receiving ilioinguinal and iliohypogastric nerve block

Conditions: Inguinal Hernia

Summary: rebound pain is a newly defined phenomenon, observed within the first 24 hours after the operation. open inguinal hernia repair is a common surgical procedure that can be associated with pain of the either acute or chronic character. a peripheral nerve block of the ilioinguinal (iin) and iliohypogastric (ihn) nerves is a relatively well-known method for postoperative pain management. however, rebound pain after iin/ihn block resolution may reduce its overall benefit. the primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

male patients older than 18 years, of american society of anesthesiologists physical status i or ii, and scheduled for unilateral primary hernia repair with a lichtenstein style (open surgery with insertion of mesh) under general anesthesia will be included in the study. the patients will be randomized using a computer-generated randomization technique. after induction of general anesthesia, the patients in the dexamethasone group (group dex) will receive 5 mg dexamethasone in a 50 ml syringe containing normal saline. the patients in the saline group (group s) will receive normal saline in a 50 ml syringe. ultrasound-guided block of the ilioinguinal (iin) and iliohypogastric (ihn) nerves will be performed on all patients included in both groups. the primary aim is to assess whether intravenous dexamethasone reduces postoperative opioid consumption and the incidence of rebound pain in patients undergoing unilateral hernia repair in adults.

Eligibility criteria:
inclusion criteria: * asa i-ii * having signed a written informed consent form * scheduled for unilateral primary hernia repair lichtenstein style (open surgery with insertion of mesh) under general anesthesia exclusion criteria: * chronic opioid use (more than one month of 60 mg of oral morphine equivalents daily) * contraindications to peripheral nerve blocks including localized infection, coagulopathy, or allergy to local anesthetics * stomach ulcer * severe obesity (body mass index \> 35 kg/m2) * uncontrolled diabetes * psychiatric disorders * systemic steroid use * neuropathic disorder * can not communicate in turkish

Keywords: dexamethasone ilioinguinal and iliohypogastric nerve block bupivacaine rebound pain
longitudinal surveillance registry (lsr) of acuity spiral

Conditions: Heart Failure

Summary: the primary purpose of the lsr of acuity spiral is to evaluate and report on the long-term performance of the acuity spiral left ventricular lead.


Eligibility criteria:
inclusion criteria: * has been or will be implanted with the acuity spiral lead within 29 days * plans to remain in the long-term care of his/her enrolling physician * is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (irb) * is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry exclusion criteria: * is unable or unwilling to comply with the protocol requirements
metabolic changes in prostate cancer patients with androgen-ablation therapy (aat)

Conditions: Prostatic Cancer

Summary: this is an observational, prospective, non-interventional and multi-centre study, to assess the impact of androgen ablation therapy in blood triglycerides, cholesterol and glucose, body fat distribution and fracture risk to ten years using frax model in patients with prostate cancer. the patients will be following for 12 months


Eligibility criteria:
inclusion criteria: * prostate cancer patient requiring androgen-ablation treatment: lhrh analogs, surgical castration, antiandrogen treatment * provision of informed consent prior to conducting any study-related procedure exclusion criteria: * patient involved in a clinical trial

Keywords: observational prospective metabolic changes metabolic syndrome diabetes prostatic cancer risk fracture
diabgad - trial to preserve insulin secretion in type 1 diabetes using gad-alum (diamyd) in combination with vitamin d and ibuprofen

Conditions: Diabetes Mellitus, Type 1

Summary: the objectives of this study is to * evaluate the safety and influence of treatment with gad-alum (diamyd) combined with vitamin d and ibuprofen on preservation of residual insulin secretion in recently diagnosed type 1 diabetes * evaluate how the above mentioned treatments influence the immune system of the subjects and interact with any viral infections * evaluate the safety and influence of treatment with double dose of gad-alum (diamyd) plus vitamin d on the immune system, viral infections, and on preservation of residual insulin secretion in recently diagnosed type 1 diabetes


Eligibility criteria:
main inclusion criteria: * male and female patients between 10 and 18 years of age * insulin dependent type 1 diabetes mellitus diagnosed within the previous 4 months at time of screening * fasting c-peptide level at time of screening above or equal to 0.12 nmol/l * elevated gad65 antibodies (gada) at time of screening main exclusion criteria: * treatment with immunosuppressants, continuous anti-inflammatory drug, vitamin d or any anti-diabetic medications other than insulin * a history of certain diseases or conditions (e.g. anemia, hiv, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc) * treatment with any vaccine within 4 months prior to first planned administration of gad-alum/placebo or planned treatment with vaccine up to 4 months after the last injections with gad-alum/placebo, including influenza vaccines * participation in other clinical trials with a new chemical entity within the previous 3 months * pregnancy or planned pregnancy within 1 year after the last gad-alum/placebo dose * presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study

Keywords: diamyd diabetes juvenile diabetes diabetes type 1 autoimmune diabetes insulin dependent diabetes type 1 diabetes type 1 diabetes mellitus rhgad65 gad gad65 gad-alum diabetes mellitus diabetes mellitus, type 1 glucose metabolism disorders metabolic diseases vitamin d ibuprofen
etiology of lymphopenia in covid19 infection

Conditions: Lymphopenia

Summary: study of the cause of lymphopenia in covid19 viral infection will be done in 3 cohorts. first cohort will be patients asymptomatic or with mild symptoms. second cohort will be patients with severe illness and admitted to icu. third cohort will be patients critically ill and on artificial ventilation.

each cohort will include 30 patients. complete blood count in all patients will be done daily in all patients. bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm. correlation of the degree of lymphopenia with the status of the patients will be done. also correlation will be done about the relation of recovery of lymphopenia and status of the patients.

Eligibility criteria:
inclusion criteria: * any patient admitted with the diagnosis of covid19 viral infection exclusion criteria: * any patient who died within one day of admission
impact of the subglottic secretions drainage on the tracheal secretions colonisation

Conditions: Ventilator-associated Pneumonia

Summary: meta-analysis provide evidence for the benefit of the subglottic secretions drainage (ssd) to reduce the occurrence of ventilator-associated pneumonia (vap). nevertheless, the diagnosis of vap is widely considered as subjective and prone to both false-positive and false negative assignments. in ths way, the impact of ssd remains controversial and its use limited in intensive care units. the demeter study assessing the medico-economical impact of the the subglottic secretions drainage (nct02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of ssd. this evaluation would reinforce the results observed during the demeter study in considering the adjudicated vap incidence. this ancillary study will be performed in 14 centers participating to the demeter study


Eligibility criteria:
inclusion criteria: * age over 18 years * invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours * intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (ssd) will be available during the ssd period of the trial * information delivered exclusion criteria: * previous inclusion in the study * patients moribund at the intensive care unit admission * pregnant, parturient or breast-feeding woman * patient hospitalized without consent and/or deprived of liberty by court's decision * patient under guardianship or curators * lack of social insurance * concomitant inclusion in a trial on vap prevention * patient with no comprehension of the french language

Keywords: ventilator-associated pneumonia surveillance subglottic-secretions critically ill patients prevention
clinical performance evaluation of dxn hcv assay

Conditions: Hepatitis C

Summary: the dxn hepatitis c virus (hcv) assay is an in vitro diagnostic assay intended as an aid in the management of of hcv-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the dxn hcv assay for plasma samples in the intended use population.

same as brief

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older * subject has measurable hcv-rna at baseline (prior to treatment start) * subject is genotype 2 or 3 and plans to undergo treatment with peginterferon (peg) plus ribavirin (rbv) or sofosbuvir (sof) plus rib * subject is genotype 1 and plans to undergo treatment with telaprevir (tel) or sof plus peg+rbv or, sof plus ledipasivr (led) * subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form. exclusion criteria: * co-infection with hiv or hepatitis b (hbv) * prior participation in study * current participation in an investigation drug or device study
evaluation of intracranial pressure during mechanical ventilation recruitment maneuver

Conditions: Effect of Recruitment Maneuver on Intracranial Pressure

Summary: recruitment maneuver is used to reopen atelectasis alveoli. positive airway pressure applied during the recruitment maneuver may increase intrathoracic pressure, resulting in hemodynamic instability, venous return disorders, and increased intracranial pressure. our study will examine the effect of recruitment maneuver on intracranial pressure by evaluating optic nerve sheath diameter change.

the therapeutic goal of mechanical ventilation shifts from maintaining regular gas exchange to preventing ventilator-induced lung injury. atelectasis aggravates lung injury by reducing the lung size available for tidal ventilation. by preventing atelectasis with positive end expiratory pressure (peep) and recruitment maneuvers, the end-expiratory lung volume can be increased, and lung damage can be reduced. although the recruitment maneuver improves oxygenation and reduces mortality, especially in patients with acute respiratory distress syndrome (ards), adverse side effects are sometimes observed. most important of these are the risk of barotrauma after positive airway pressure applications, increased intrathoracic pressure and hemodynamic instability, and increased intracranial pressure risk after venous return disorder. our study aimed to evaluate the effect of recruitment maneuver on intracranial pressure by measuring optic nerve diameter with ultrasound before and after its application in patients with ards with impaired oxygenation and followed up with mechanical ventilator support.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients followed in the intensive care unit (icu) * patients on mechanical ventilation support * patients diagnosed with ards according to the berlin criteria * patients with oxygen saturation (spo2) ≤ 92% exclusion criteria: * younger than 18 * patients with increased inotropic drug requirement or mean arterial pressure \<65 mmhg in the last 2 hours * patients with intracranial hypertension * patients with acute coronary syndrome * patients with hypercapnia, pneumothorax, subcutaneous emphysema, and pneumomediastinum

Keywords: recruitment maneuver intracranial pressure optic nerve sheath diameter acute respiratory distress syndrome
the copenhagen gender identity cohort

Conditions: Gender Identity; Gender Dysphoria, Adult; Gender Incongruence

Summary: the goal of this observational study is to systematically collect data on adults seeking medical and surgical treatments for gender incongruence. this prospective, longitudinal cohort aims to generate insights into the safety, effectiveness, and overall satisfaction with current treatments. additionally, the study seeks to identify areas for improvement and support healthcare professionals in making informed decisions. most importantly, it aims to enhance the quality of life for transgender and gender-diverse individuals by ensuring that the care they receive aligns with their needs and goals. participants will include patients seeking treatment at the copenhagen center for gender identity, denmark. data collection will be both clinician- and patient-reported. participants will be asked to complete online surveys at baseline, after the assessment process, and annually if they initiate hormone therapy. the study will systematically gather information on gender identity and transition experiences, sociodemographics, self-medication, health status, self-reported quality of life, and treatment preferences. additionally, detailed records of treatment courses and specific interventions will be collected from all involved healthcare providers across specialties. the study will evaluate the effects of different treatment options, both in the short and long term. it will explore how quality of life is associated with gender identity, transition, sociodemographics, lifestyle, and health, as well as assess the medical impact of various treatments, including counseling, hormone therapy, and surgery. furthermore, the study will investigate the prevalence of side effects and complications related to treatment, as well as factors influencing treatment discontinuation, including cases of detransition. finally, the project will focus on quality indicators such as waiting times and patient satisfaction, contributing to the ongoing development of high-quality, patient-centered care for transgender and gender-diverse individuals.


Eligibility criteria:
inclusion criteria: * all patients referred to the center for gender identity in copenhagen exclusion criteria: * inability to read and understand danish

Keywords: gender identity gender incongruence
susceptibility genes in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the main objective of the study is to define, for autism spectrum disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. for this purpose the investigators will take advantage of large, well-characterized cohorts of patients with autism spectrum disorder for genetic screenings. targeted sequencing of selected synaptic genes, previously associated with autism spectrum disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. genomic data from copy number variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. the investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations and set up an induced pluripotent stem cells collection from selected patients with synaptic mutations for functional and expression analysis.

specific aims are: aim 1: to identify genetic variants in selected synaptic genes, by targeted sequencing with deep coverage of coding regions and a strong focus on previously untested regulatory regions in autism spectrum disorder aim 2: to define the range of clinical phenotypes caused by mutations in synaptic genes by establishing detailed genotype/phenotype correlations and analyzing segregation in families with multiple individuals affected by autism spectrum disorder, autism spectrum disorder traits or other neuropsychiatric disorders aim 3: to generate a repository of induced pluripotent stem cells from autism spectrum disorder subjects with synaptic mutations for translational studies, including expression and functional assays. aim 4: to identify the neuronal phenotypes caused by deleterious synaptic mutations for further translational studies

Eligibility criteria:
inclusion criteria: * diagnosis for autism spectrum disorders or autism using the autism diagnostic interview-revised (adi-r) criteria for autism and autism diagnostic observation schedule (ados-g) criteria exclusion criteria: * patients with profound intellectual disability or with a known medical cause of autism, such as neurocutaneous syndromes, fragile x, metabolic disorders, extreme prematurity, congenital rubella and other prenatal or postnatal neurological infections or gross dysmorphology, will be excluded

Keywords: autism asperger pervasive developmental disorder no otherwise specify gene polymorphism mutation
physician-initiated medication review in a type 2 diabetes outpatient clinic

Conditions: Polypharmacy

Summary: aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.

patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. the intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. follow-up is 6 months. primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.

Eligibility criteria:
inclusion criteria: 1. dm2 2. 12 medications in the central prescription list exclusion criteria: 1. inability to give written consent (e.g., inability to understand the intervention or language barriers); 2. active cancer or palliative treatment; 3. admitted to the hospital.

Keywords: polypharmacy
a real-world study of liposomal irinotecan (onivyde)-based therapy in patients with locally advanced/metastatic pancreatic cancer in china

Conditions: Advanced Pancreatic Cancer

Summary: this study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (onivyde®)-based treatment scheme in chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.

chinese patients with pancreatic cancer are mostly treated according to foreign clinical research, lacking the diagnosis and treatment data of efficacy and safety of chinese population. in the napoli-1 study, irinotecan liposomes (onivyde®) the combination of 5-fluorouracil and folinic acid (nal-iri+5-fu/lv) has shown survival benefits in patients with metastatic pancreatic ductal adenocarcinoma (mpdac) who have previously received gemcitabine-based treatment. the napoli-3 study showed that nalirifox (nal-iri+oxaliplatin+5-fu/lv) significantly improved overall survival (os) and progression free survival (pfs) compared to albumin bound paclitaxel and gemcitabine in newly diagnosed mpdac patients. however, the efficacy and safety data of nal-iri-based treatment regimens in china are limited. in august 2023, onivyde® was commercially listed in china. the purpose of this study is to: ① evaluate the real world efficacy and safety of onivyde®-based treatment schemes in chinese patients with locally advanced or metastatic pancreatic cancer; ② analyze the efficacy of onivyde® treatment and the efficacy of all pancreatic cancer patients who have not received relevant treatment using the project data of china advanced pancreatic cancer big data center (renji hospital cancer department is the national leading unit), in conjunction with the survival follow-up data of china center for disease control and prevention of chronic non communicable diseases.

Eligibility criteria:
inclusion criteria of the experimental group: * age ≥ 18 years old. * patients with locally advanced or metastatic pdac diagnosed by pathology. * patients who received at least one cycle of nal-iri (onivyde®）+ 5-fu/lv treatment. * patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past. * the patient voluntarily participates in the study and signs an informed consent form. inclusion criteria of the control group: * age ≥ 18 years old. * patients with locally advanced or metastatic pdac diagnosed by pathology. * not received nal iri (onivyde®)+ 5-fu/lv treatment in the past. exclusion criteria: * confirm pregnant or lactating women. * the patient's clinical data is not available. * the researchers determined that they were not suitable for inclusion in the study due to other circumstances.

Keywords: pancreatic cancer chemotherapy liposomal irinotecan real world research
efficacy and safety study of octreotide implant in patients with acromegaly

Conditions: Acromegaly

Summary: evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

this study will be conducted in 3 phases: screening, the primary treatment phase (ie, day 1 to week 24), and the extension phase (post week 24 to week 48). primary efficacy and safety will be determined from the primary treatment phase. eligible patients will be randomized during the primary treatment phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy injections of s-lar. each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. all patients who complete the primary treatment phase and who continue to meet eligibility criteria will be offered the opportunity to enter the extension phase; patients entering the extension phase will be treated with an octreotide implant for 6 months.during the extension phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.

Eligibility criteria:
inclusion criteria: * male and female patients with acromegaly * confirmed diagnosis of a growth hormone-secreting tumor * received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening * must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: igf-1 \< 20% above the upper limit of normal age and sex-adjusted levels and gh ≤ 2.5 ng/ml exclusion criteria: * patients with pituitary surgery less than 3 months prior to screening * uncontrolled diabetes defined as having a fasting glucose \> 150 mg/dl and hba1c \>= 9% * symptomatic cholelithiasis * received pegvisomant, lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial * received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before screening

Keywords: octreotide sandostatin lar growth hormone igf-1