Kornimate/medical-research-clean huggingface dataset:
a study of lcar-g08 in subjects with advanced gastrointestinal tumors expressing guanylyl cyclase c (gcc)

Conditions: Advanced Gastrointestinal Tumors

Summary: this is a phase 1, single-arm, open-label, dose escalation and expansion study of lcar-g08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase c (gcc).

this is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based lcar- g08 in subjects with guanylyl cyclase c (gcc)-positive advanced gastrointestinal tumors. subjects who meet the eligibility criteria will receive lcar-g08 infusion. the study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Eligibility criteria:
inclusion criteria: * voluntary agreement to provide written informed consent. * histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer). * aged 18 to 70 years, either sex. * gcc immunohistochemistry (ihc) staining is positive. * at least one measurable tumor lesion according to recist v1.1. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * expected survival ≥ 3 months. * clinical laboratory values meet screening visit criteria. exclusion criteria: * previous car-t cell, t cell receptor-engineered (tcr) t cell, or therapeutic tumor vaccination treatment within the past 6 months; and the corresponding car-t, tcr-t cells can still be detected. * ever received any treatment targeting gcc. * prior antitumor therapy with insufficient washout period. * brain metastases. * pregnant or lactating women. * hepatitis c virus (hcv) antibody-positive or human immunodeficiency virus (hiv) antibody-positive, active syphilis, epstein-barr virus (ebv) infected. * severe underlying disease. * presence of other serious pre-existing medical conditions that may limit patient participation in the study.any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study. any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Keywords: advanced gastrointestinal tumors
insulinotropic effect of gip and glp-1 before and after reduced glucose tolerance

Conditions: Insulin Resistance; Deteriorated Glucose Homeostasis; Inactivity

Summary: the incretin effect in patients with type two diabetes is reduced. the investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. the purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

the incretin effect in patients with type two diabetes is reduced. the investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. the purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. the evaluation is done by infusing gip, glp-1 or saline during hyperglycemic clamps.

Eligibility criteria:
inclusion criteria: * caucasians without type 2 diabetes mellitus * normal ogtt (75 g of glucose) according to who's criteria * bmi 20-30 * hemoglobin \> 8.0 mmol/l * informed consent exclusion criteria: * liver disease (alat \> 2 x normal level) * nephropathy (s-creatinin \> 130 µm or albuminuria) * relatives (parents/siblings) with t2dm * medical treatment witch cannot be stopped for 12 hours

Keywords: incretin hormones glucagon insulin/c-peptide plasma glucose insulin resistance deteriorated glucose homeostasis inactivity
no-biopsy approach in celiac disease: cut-off points for iga anti-tissue transglutaminase assays

Conditions: Celiac Disease

Summary: the main objective of this multicenter and observational study is to define the optimal threshold of different commercially available iga anti-transglutaminase (ttg-iga) antibody assays for celiac disease diagnosis (cd) avoiding the need for an intestinal biopsy. the main questions to be answered are: * is the anti-ttg-iga titer cut-off above 10 times the upper limit of normal (uln) useful in all anti-ttg iga assays? * is the diagnostic performance of the newly defined cut-offs of anti-ttg-iga the same in all the evaluated assays? * is the dynamic of the anti-ttg-iga levels after the introduction of the gluten-free diet (gfd) similar across the different assays included in the study? this is a prospective multicenter study that will enroll pediatric and adult patients with new-onset cd during the years 2023 and 2024. serum from these patients will be collected for the determination of anti-ttg-iga according to the local methodology (participating hospital) and by the anti-ttg iga assays most commonly used in our country, which will be centralized in the same reference center (hospital universitario la paz).


Eligibility criteria:
inclusion criteria: * patients, on gluten-containing diet, with tgt-iga antibodies \> upper limit of normal (uln) and intestinal biopsy confirming celiac disease (cd). * patients with tcrγδ+ \>10% combined with decrease nk-like intraepithelial lymphocytes in the intestinal epithelium. * paediatric patients who meet espghan criteria (tgt-iga antibodies \>10xuln) without duodenal biopsy performed. exclusion criteria: * patients already diagnosed with cd. * patients who refused duodenal biopsy. * patients with primary or secondary immunodeficiencies. * patients with malignancy. * recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.

Keywords: anti-transglutaminase iga no-biopsy approach
impact of sleep disordered breathing in older adults

Conditions: Cardiovascular Diseases; Hypertension; Depression; Sleep Apnea Syndromes; Lung Diseases

Summary: to test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.

background: the health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. the study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. the study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention. design narrative: the study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. the study used the veterans administration normative aging study (nas) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. blood pressure, health-related quality of life, and depression score were also assessed in the home. the potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the effect of intranasal insulin on motor and non-motor symptoms in parkinson's disease patients

Conditions: Parkinson Disease

Summary: this study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with parkinson's disease over a 12-week period.

this study is a single-center, parallel and double-blind study. patients with parkinson's disease referred to movement clinic of shohada-e-tajrish hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. primary outcome is motor symptoms (mds-updrs; part iii, iv), and secondary outcomes are motor (gait balance) and non-motor (mds-updrs part i, ii, cognition, depression, anxiety and fatigue) symptoms. patients, researchers (physicians, outcome assessors) and data analysts are blinded.

Eligibility criteria:
inclusion criteria: * man and woman over 17 years old * patient with parkinson's disease according to uk parkinson's disease society brain bank diagnostic criteria * provide written informed consent to participate in the study. * understand that they may withdraw their consent at any time. exclusion criteria: * pregnant and lactating women * patients with diabetes and taking anti-hyperglycemic drugs * patients with other neurodegenerative diseases like multiple system atrophy, huntington's, wilson's disease, alzheimer's, amyotrophic lateral sclerosis (als), progressive supranuclear palsy, etc. * patients who cannot walk for more than one minute without help * a history of allergic reaction to insulin * the presence of inflammation of nasal cavity that may prevents absorption of insulin

Keywords: parkinson's disease insulin intranasal motor symptoms non-motor symptoms
omega-3 fatty acids as adjunctive treatment for adolescents with eating disorders

Conditions: Eating Disorder

Summary: eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. with regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. these fatty acids are essential components of the brain and are important for normal functioning of the body. since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. the investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.


Eligibility criteria:
inclusion criteria: * diagnosis of eating disorder, less than 18 years of age exclusion criteria: * unable to read and understand english
ml models for predicting postoperative peritoneal metastasis after hepatocellular carcinoma rupture

Conditions: Peritoneal Metastasis

Summary: this study aimed to address the issue of peritoneal metastasis (pm) following the rupture of hepatocellular carcinoma (hcc) and its adverse impact on patient prognosis. clinical data from 522 patients with ruptured hcc who underwent surgery at seven different medical centers were collected and analyzed. machine learning models were employed for analysis and prediction.


Eligibility criteria:
inclusion criteria:(1) hcc confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) r0 resection (4) first tumor detection - exclusion criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data -
cancer pain single nucleotide polymorphisms (snps)

Conditions: Cancer; Pain

Summary: cancer pain is common in advanced cancer patients. opioids are the mainstay of treatment in cancer pain. responsiveness to and tolerability of opioids is, amongst others, determined by small variations in human dna. using blood samples from clinically well-defined cancer pain patients, the investigators are going to analyze single nucleotide polymorphisms (snps) in genes that are known to be involved in responsiveness to opioids and sensitivity to pain.


Eligibility criteria:
inclusion criteria: * cancer pain patients exclusion criteria: * patients not able to provide informed consent

Keywords: cancer pain snp
volume flow-guided angioplasty of dysfunctional dialysis access

Conditions: Dialysis Access Malfunction

Summary: this is a pilot study investigating a new concept of intra-procedural percutaneous duplex ultrasound (dus) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (avf).

this is a prospective, single-center, single-arm clinical trial introducing a new functional index of clinical success of endovascular treatment and investigating the feasibility of volume flow-guided balloon angioplasty of dysfunctional avf assessed with intraprocedural percutaneous dus. the study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional avf in the investigator's center. exclusion criteria will be: (i) not available volume flow values at the time of avf maturation, (ii) patients with arteriovenous synthetic grafts. patients' demographical data, dialysis access history, and procedural details will be recorded. intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (qva) performed by an independent investigator blinded to the volume flow analysis outcomes. follow up dus imaging including volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while fistulograms with qva analysis will be performed at 6 and 12 months. all dus measurements will be performed using the same imaging protocol and the same operator. the study's primary endpoints will be (i) the quantification of angioplasty outcome using sequential dus volume flow analysis following each balloon catheter dilation and (ii) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month. secondary endpoints will be (i) re-intervention-free interval defined as the time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated avf and (ii) correlation between volume flow and qva measurements.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional avf * signed consent form * agree to the imaging protocol exclusion criteria: * not available volume flow values at the time of avf maturation * patients with arteriovenous synthetic grafts.

Keywords: percutaneous transluminal angioplasty volume-flow measurment autologous arteriovenous fistula dialysis access
adversity, brain and opioid use study

Conditions: Opioid Use Disorder; Healthy

Summary: the way people process and remember information may be related to adverse childhood experiences and opioid use disorder symptoms. the purpose of this project is to examine brain function and performance during learning and memory tasks in adults. the study will compare measures of learning and memory across three groups of participants: those with an opioid use disorder (oud) that take buprenorphine for opioid replacement therapy, adults without an opioid use disorder taking buprenorphine, and healthy adults that do not have an opioid use disorder and are not taking buprenorphine.


Eligibility criteria:
inclusion criteria for all groups: * right handed * able to give informed consent * normal/corrected-to-normal vision and hearing inclusion criteria for opioid use disorder (oud) group: * diagnosis of oud * be actively receiving buprenorphine (bup) for opioid agonist therapy * be free from illicit substance use for at least 2 weeks * the study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol) inclusion criteria for the bup control group: * taking bup for chronic pain * no substance use disorder (including oud) * the study will allow stable dose (\> 3 months) of commonly prescribed psychiatric medications and some sleep aids (per protocol) inclusion criteria for healthy participant group: * not taking bup * free of any psychiatric or major medical conditions exclusion criteria for all groups: * significant medical or neurologic conditions (e.g., stroke, seizures, multiple sclerosis) * actively suicidal * contraindication for mri * inability to tolerate small, enclosed spaces without anxiety * life history of schizophrenia, bipolar disorder, learning disability, attention deficit disorder, or pervasive developmental disorder * use of substances or prescription medications that could interfere with measures of interest (per protocol) * unable to provide informed consent * participants who have completed other studies in our lab involving learning and memory assessments with the same/similar tasks used here (hum00230585, hum00121812) will not be eligible to complete the current study, due to possible learning/practice effects * unable to fit comfortably in the mri scanner due to body size (typically men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs).

Keywords: magnetic resonance imaging (mri) adverse childhood experiences fear learning memory hippocampal function
changes in preference for surgery of patients signed up for arthroscopic procedures

Conditions: Arthroscopy

Summary: this study describes the changes in preference to arthroscopic surgery in two orthopedics departments in denmark under the covid-19 pandemic.

background: covid-19 has impacted all aspects of society. in hospitals around the world focus has been on treating the deadly virus, and elective orthopedic surgical procedures has been postponed in denmark, causing a stop for most arthroscopic procedures for months. it is established that certain conditions leading to arthroscopic orthopedic intervention has fluctuating symptoms symptoms and can have a favorable outcome on conservative treatment. amongst these conditions who are also treated with non-surgical methods are subacromial decompression impingement\[1\]\[1\], degenerative knee disease \[2\] and anterior cruciate ligament injuries\[3\]. an issue with further understanding the non-surgical effect on this patient group has beencould be reluctance to undergo conservative non-surgical treatment and opt for a surgical treatment. procedure. because all elective surgery has been postponed in denmark, and the following longer waiting period for surgery, this has created a unique opportunity to further investigate this patient category. aim of study: investigate the impact of time on waiting list for surgery under covid-19 pandemic on the preference for surgery in patients planned for arthroscopic surgery. discussion the current study will provide information on the change of preferences forto arthroscopic surgery in a patient population who are forced to wait for surgery for a longer period of time, with no possibility of seeking treatment in other hospitals.

Eligibility criteria:
inclusion criteria: * patients planned for arthroscopic intervention in knee or shoulder. * patients seen by an orthopedic surgeon and planned for surgery before 13/3-20 exclusion criteria: * surgery performed in another hospital * death * emigration

Keywords: arthroscopy shoulder impingement syndrome patient preference covid-19 public health clinical decision-making
a comparative study of knee systems

Conditions: Osteoarthritis of the Knee

Summary: the custom cutting guides personalized for each patient via pre-operative mri will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.


Eligibility criteria:
inclusion criteria: * must be scheduled to undergo tka with no bilateral tka planned within 6 weeks of the initial surgery date * must be 18 years of age or older * must be capable and willing to provide informed consent * must have flexion contracture less than 15 degrees. * must have ligament stability no more than 2 degrees instability in varus/valgus extension stress exclusion criteria: * medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op * currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure * known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process * knee alignment deformities greater than 7 degrees varus or valgus * known prior knee revisions or previous surgeries deemed to compromise the tka incision exposure * known medical conditions prohibiting the use of mri or nickel allergy, sensitivity, or hardware in the region of the knee

Keywords: total joint replacement knee
arise: after 8 hours reperfusion in ischemic stroke embolization

Conditions: Ischemic Stroke

Summary: a prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or iv thrombolytic treatment and are screen with ct or mr perfusion imaging showing penumbra and infarction not \> 1/3rd the territory.

Eligibility criteria:
inclusion criteria: * over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (iv t-pa ) or * mechanical thrombectomy vessels - intracranial vertebral artery, basilar artery, intracranial ica, ica terminus bifurcation, mca m1/m2, or * aca nihss ≥ 7 mri dwi/pwi or * cta/p, which demonstrates an area of mismatch ≥ 2/3 rd * signed informed consent exclusion criteria: * creat \>= 2 * nihss \< 7 * baseline mrs \>= 2 * infarct \> 1/3rd mca territory * competing trials * prior iv or ia treatment