Kornimate/medical-research-clean huggingface dataset:
a study of bgb-b3227 alone and in combination with tislelizumab in participants with advanced or metastatic solid tumors

Conditions: Advanced Cancer; Advanced Solid Tumor; Metastatic Cancer; Metastatic Solid Tumor

Summary: this is a first-in-human (fih), open-label, multicenter dose escalation and expansion study of bgb-b3227, a humanized immunoglobulin g1 (igg1) antibody. the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and preliminary antitumor activity of bgb-b3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors. the study will also identify recommended dose(s) for expansion (rdfe\[s\]) of bgb-b3227 administered alone and in combination with tislelizumab.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic solid tumors with a high prevalence of mucin-1 (muc1) expression * at least 1 measurable lesion per recist v1.1 * stable eastern cooperative oncology group performance status of ≤ 1 * adequate organ function * willing to use a highly effective method of birth control exclusion criteria: * history of prior ≥ grade 3 cytokine release syndrome (crs) * history of severe infusion-related reactions (irrs), allergic reactions, or hypersensitivity to any ingredients or components of the study treatments * infection requiring systemic (oral or intravenous) therapy ≤ 14 days before the first dose of study drug(s), or participants with symptomatic covid-19 infection * active leptomeningeal disease or uncontrolled, untreated brain metastasis * active autoimmune disease or history of autoimmune disease(s) that may relapse note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bgb-b3227 tislelizumab bgb-a317 advanced solid tumor metastatic solid tumor
patient-reported efficacy of subcutaneous (sc) abatacept in rheumatoid arthritis (ra) - south africa

Conditions: Rheumatoid Arthritis

Summary: research question: what are the patterns of patient-reported changes in physical function among adult patients using sc abatacept with moderate to severe ra since commencement of the compassionate use program (cup).


Eligibility criteria:
inclusion criteria: * the global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the cup
medical dispatchers' perception of visual information in real out-of-hospital cardiac arrest

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: dispatcher-assisted cardiopulmonary resuscitation is a complex, nonvisual procedure that is challenging for the dispatcher. the aim was to explore the medical dispatchers' perception of bystanders' responses and dispatchers' reflections about the added value of visual information in out-of-hospital cardiac arrests (ohca) situations.

ten individual interviews with medical dispatchers who had previously handled an emergency call concerning ohca captured on closed-circuit television (cctv) were conducted. first, the medical dispatcher listened to the emergency call and described their perception of the scenario. afterward, the cctv recording was shown to the dispatcher, who was then interviewed. the interviews were videotaped, and the audio files were transcribed verbatim. thematic content analysis was conducted.

Eligibility criteria:
inclusion criteria: * emergency medical dispatchers who had previously handled an emergency call concerning ohca captured on closed-circuit television (cctv) exclusion criteria: * none

Keywords: dispatcher-assisted cardiopulmonary resuscitation out-of-hospital cardiac arrest emergency medical dispatcher
perceptions and experiences of (family members of) people with mental illness about the chance for mental illness in (future) children, and needs for care and research

Conditions: Mental Illness

Summary: despite consistent evidence that mental illness runs in families, intergenerational transmission of risk of mental illness is rarely considered in clinical practice. neither preventive programs for children of parents with mental illness are usually implemented in care, nor supportive programs for parenting. furthermore, parents with mental illness are not always aware of how their disorder may impact the well-being of their children. to date, the needs for counseling, care and research in parents with mental illness and family members of people with mental illness are unclear. therefore, this prospective qualitative interview study aims to gain insights into the perceptions and experiences of (future) parents with mental illness, partners and family members of people with mental illness about risk for and resilience against mental illness in (future) children, as well as their needs for counseling, care and research.


Eligibility criteria:
inclusion criteria: * having (a partner or relative with) a diagnosis of a mental illness in the mood-psychosis spectrum, i.e., psychotic disorder, bipolar disorder, or severe depression * at least 18 years old exclusion criteria: * insufficient proficiency of the dutch language * no demonstration of adequate understanding of the purpose, procedures, risks, benefits, emergency contacts, and payment issues (in accordance with criteria to assess capacities to consent from appelbaum \& grisso, 1988). * unable to give consent to all aspects of the study.

Keywords: mental illness risk resilience offspring qualitative research mood-psychosis spectrum
bio-assay development and implementation for fungal infection detection

Conditions: Candidemia

Summary: the purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.

the study discussed here is part of a broader research project (iof project) that is aimed at the development and implementation of a point-of-care devices, in which fiber-optic surface plasmon resonance (fo-spr) is used as a detection system. this project includes the development and implementation of the (fungdetect) sensor for fast and accurate detection of fungal pathogens in human blood samples. in first instance, the sensor will be tested in buffer solutions spiked with a known amount of candida albicans cells. further validation of the prototype includes detection of these cells in human blood samples. in a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different candida spp.. a second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. the blood samples will be collected from patients of university hospitals (uz) leuven.

Eligibility criteria:
inclusion criteria: * healthy volunteers for validation of the (fungdetect) sensor (spiked blood samples) * candidemia exclusion criteria: * none

Keywords: candida bloodstream infection detection fungal cells fiber-optic surface plasmon resonance (fo-spr)
effect of gastric bypass surgery on pancreatic islet and incretin function - follow-up study

Conditions: Obesity

Summary: to examine pancreatic islet function and incretin function during intravenous and oral stimulation \>2 years after gastric bypass surgery in patients with normal glucose tolerance. we hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.


Eligibility criteria:
inclusion criteria: * participation in previous study (nct01559779) exclusion criteria: * pregnancy/lactation * major chronic disease develop since previous examination with possible impact on outcomes

Keywords: obesity gastric bypass bariatric surgery incretin function islet function
urolithin a supplementation in middle-aged adults with obesity

Conditions: Obesity; Vascular Dementia; Cognitive Impairment

Summary: the goal of this clinical trial is to learn about the effect of urolithin a, a dietary supplement, on blood flow in middle-aged adults with obesity. the main question it aims to answer is: - does urolithin a supplementation improve blood flow in large and small blood vessels in middle-aged adults with obesity? participants will be asked to: * take the dietary supplement daily for 4 weeks * attend two study visits to have their blood vessels checked, answer questionnaires, and give a sample of blood researchers will compare people who took the dietary supplement with others who took a placebo to see if the blood flow in the blood vessels improved.

this study aims to measure the effect of urolithin a supplementation on endothelial function, cerebral blood flow regulation, and serum biomarkers of no bioavailability and mitochondrial function in middle-aged adults with obesity. briefly, 54 adults aged 40-64 years of age with a body mass index equal to or greater than 30 kg/m2 will be recruited to participate in a double-blind placebo-controlled parallel study for 4 weeks. participants will be randomly assigned to intervention or control group. those in the intervention group will consume 1,000 mg of urolithin a daily in the form of softgel capsules, whereas those in the control group will consume a placebo. data collection will occur at baseline (day 0) and endpoint (day 28). the investigators will compare outcomes between control and intervention group. researchers expect that urolithin a supplementation in middle-aged adults with obesity improves endothelial function and cerebral blood flow regulation, and that this improvement is accompanied by changes in biomarkers of no bioavailability and mitochondrial function.

Eligibility criteria:
inclusion criteria: * age: 40-64 years old, inclusive * obesity \[bmi ≥30 kg/m2\] * ability to read, write, and speak english * competence to provide written informed consent exclusion criteria: * pregnant or breastfeeding women, or women who intend to become pregnant within the study period * history of uncontrolled hypertension * history of uncontrolled type 1 or type 2 diabetes mellitus * significant cardiac disease or chest pain in the last 6 months * history of untreated depression or anxiety * history of cognitive impairment * history of uncontrolled significant gi disease (e.g., ibs, crohn's disease) * allergy or intolerance to one or more of the intervention components * undergoing treatment for active cancer * history of neurodegenerative disorders (e.g., multiple sclerosis) * presence of any condition affecting swallowing ability * any other medical condition that the investigators deem would adversely affect the participant's safety or ability to complete the study

Keywords: obesity urolithin a middle aged flow-mediated dilation endothelial function fnirs nitric oxide vascular contributions to cognitive impairment and dementia
can diagnostics and pharmacological prescriptions in patients with heart failure be improved in general practice?

Conditions: Heart Failure

Summary: this study will explore the possible effect of a tailored educational intervention towards general practitioners in norway, in order to improve the quality of treatment for heart failure in general practice.

chronic heart failure (hf) is a syndrome with a poor prognosis and with a prevalence increasing steeply by patients' age. studies indicate that there are large potentials for improving general practitioners' diagnosis and management of hf. we have designed an educational intervention aiming at improving gps' diagnosis and management of hf. peer continuous medical education (cme) groups in general practice will be recruited to a cluster randomised educational intervention study. participating groups will be randomised either to an intervention- or a control group. a multifaceted intervention has been tailored where key components are educational outreach visits (eov) to the cme-groups, audit, and feedback. trained gps will conduct the eovs during which evidence-based recommendations for diagnosis and treatment of hf will be presented. a software will be handed out for installation on participants' practice computers, enabling collection of diagnosis- and prescription-data. the captured data will subsequently be linked to corresponding data from the norwegian prescription database (norpd). individual feedback reports will be sent each participant in the beginning and at the end of the study. main outcomes measure is the proportion of hf patients prescribed an ace-inhibitor (or an angiotensine receptor blocker) and a betablocker in combination. baseline data will provide material for a descriptive, cross sectional study. patient related outcomes in terms of hf-hospital admissions and all cause mortality will be obtained by record linkage with norpd and the norwegian patient registry. included in the intervention group is also a sub-study using a pop-up programme to facilitate disclosure of non-diagnosed hf patients in own practice. finally, we plan a questionnaire study (among gps in intervention group and their hf-patients) to get more knowledge regarding diagnostic workup, quality of care, non-pharmacological issues, and chronic care management of hf.

Eligibility criteria:
inclusion criteria: * general practitioner * specialist in general practice

Keywords: aged family practice
high-intensity interval training on women with polycystic ovary syndrome.

Conditions: Polycystic Ovary Syndrome

Summary: this rct is aimed towards determining the effectiveness of exercises based intervention strategy involving high intensity interval training exercises in improving serum testosterone level, body fat composition and physical activity in hopes to provide a definitive exercise regime for the ever common symptoms of pcos. it will be based on the theory that exercise helps in decreasing testosterone level that in turn decrease high androgen levels in the body, exercise further decreases body fat composition (obesity is a common cause or manifestation of pcos).

high intensity interval training will be performed over the course of 12 weeks and will be compared with the group performing strength training. baseline assessments will be done before the start of the first session and post-test assessment will be done after the last session of the study. envelope method is used for the purpose of randomization. 50 envelopes having a title of group a and group b will be made and divided into two (25 in each group). mutually exclusive technique will be used and the envelope once picked will not be replaced within the groups. sample size is calculated by using a previous study conducted in 2015 titled as, 'effects of high intensity interval training and strength training on metabolic, cardiovascular and hormonal outcomes in women with poly cystic ovary syndrome: a pilot study' by taking a confidence interval ci of 95%, power of test 80%, standard deviation of 6.3 and mean difference of 5.2, a sample size of 50 is calculated. for the analysis of the data medcalc software version 19.0.5. will be used. descriptive statistics will be performed for the purpose of demographic information and this data will be presented in terms of frequency and percentage. skewness and kurtosis will be used in order to determine the normality of data. if the data is normally distributed, then for within the group analysis dependent t test will be performed. however, in case the data is not normally distributed wilcoxon sign rank test will be performed. independent t test will be performed for the comparison between the two groups.

Eligibility criteria:
inclusion criteria: * bmi: 1. overweight: 23-24.9 kg/m2. 2. obese: greater than or equal to 25 kg/m2 . * diagnosed and referred pco patients to the rehabilitation unit would be selected for the study. * aged 18-40. * high serum testosterone level: normal range 6-86 ng/dl. exclusion criteria: * on-going pregnancy. * any cardiovascular complication. * any other endocrine disorder * any musculoskeletal condition that hinders in performing the exercise training protocol.

Keywords: high intensity interval training exercise polycystic ovary syndrome physical therapy strength training testosterone physical activity
a safety and efficacy study of treatment combinations with and without chemotherapy in adult participants with advanced upper gastrointestinal tract malignancies

Conditions: Gastrointestinal Tract Malignancies

Summary: the purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, gej, and esophageal adenocarcinoma. chemotherapy will consist of folfox (oxaliplatin, leucovorin, fluorouracil).


Eligibility criteria:
key inclusion criteria: * participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, gej, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the investigator * eastern cooperative oncology group (ecog) performance score of 0-1 * at least one measurable target lesion per recist v1.1. * adequate organ and marrow function * able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central pd-l1 testing key exclusion criteria: * participants with underlying medical conditions that, in the investigator's or sponsor's opinion, will make the administration of investigational products hazardous * only for cohort a: known human epidermal growth factor receptor 2 (her-2) positive tumor * known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. participants with leptomeningeal metastases are excluded from enrollment. * discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-tigit monoclonal antibody. * history of trauma or major surgery within 28 days prior to enrollment. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: domvanalimab quemliclustat zimberelimab esophageal adenocarcinoma gastric adenocarcinoma gastric cancer gastroesophageal junction cancer anti-pd-1 antibody anti-cd73 anti-tigit antibody
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for heart disease

Conditions: Congestive Heart Failure; Angina

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina

this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of congestive heart failure and angina. patients will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease an autologous effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility criteria:
inclusion criteria: * diagnosis of congestive heart failure or angina * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: angina congestive heart failure stem cell treatment
high-voltage pulsed radiofrequency on gasserian ganglion to treat patients with primary trigeminal neuralgia

Conditions: Idiopathic Trigeminal Neuralgia

Summary: the study is designed to compare the effectiveness and safety of high-voltage pulsed radiofrequency and nerve block for the treatment of primary trigeminal neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for trigeminal neuralgia patients.

trigeminal neuralgia (tn) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. pulsed radiofrequency (prf) is a noninvasive pain intervention technique for the treatment of tn. however, its treatment effectiveness has rarely been reported and remains controversial among scholars. a recent single-center preliminary clinical study showed that high-voltage prf had significant effectiveness in the treatment of tn. however, whether high-voltage prf treatment can become an optional treatment for tn patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. the study is designed to compare the effectiveness and safety of high-voltage prf and nerve block for the treatment of primary tn patients with ineffective conservative treatment and explore better non-surgical treatment methods for tn patients.

Eligibility criteria:
inclusion criteria: * diagnosis of primary trigeminal neuralgia meets the criteria of the international classification of headache disorders. * 18-75 years old. * response to drug treatment poorly or unable to tolerate the side effects of drugs. * a bni pain intensity scale score of iv-v. * supposed to undergo neurosurgical intervention according to trigeminal neuralgia treatment guidelines. * agree to participate in this trial and have signed the informed consent. exclusion criteria: * abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders. * abnormal electrocardiogram or chest x-ray results. * severe cardiopulmonary dysfunction. * infection at the puncture site. * history of mental illness, or history of narcotic drug abuse. * allergy to local anesthetic drugs or steroids. * cannot cooperate with the treatment. * history of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.

Keywords: trigeminal neuralgia pulsed radiofrequency gasserian ganglion
impact of face-to-face meditation on non-attachment to self and identity threat

Conditions: Meditation

Summary: meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. however, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested. to understand these mechanisms actions, it is essential to distinguish meditative practices. three different categories of meditation can be distinguished: "attention family", "constructive family" and "deconstructive family" with specific effects for each.

the aim of the study is to compare the effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat

Eligibility criteria:
inclusion criteria: * male or female * aged of 18 and more * without diagnosed psychiatric pathology * not practicing meditation * agreeing to participate in the study exclusion criteria: - less than 18 years old

Keywords: non-attachment to the self identity threat face-to-face meditation focused attention contemplation