Kornimate/medical-research-clean huggingface dataset:
the invade study: innominate vein approach for central catheterization in difficult to cannulate patients

Conditions: Critical Illness

Summary: most recent guidelines suggest central venous access must be performed with real-time ultrasound guidance, and the most recommended site for cannulation is internal jugular vein (ijv); however, it is recognized that evidence for other sites is, at present, limited. besides, guidelines does not account for patients with small vein cross-sectional area and/or respirophasic collapse, which can make the procedure more difficult or even impossible. the investigators aim to compare three different insertion sites for central venous access, with real-time ultrasound guidance

ultrasound-guided cannulation of central veins is successful in \>95% of the cases, according to the largest study so far. however, this and other studies with similar success rate, are performed in patients with general anesthesia and/or neuromuscular blockade, without spontaneous respiratory efforts. critical care physicians and many other specialists frequently need to cannulate patients in special circumstances as hypovolemia, pain, anxiety, and respiratory efforts that promotes respirophasic variation in cross-sectional area, and even complete collapse of the vessel. these changes can increase the probability of posterior wall or arterial puncture, hematomas, pneumothorax, etc. supraclavicular approach for cannulation of the subclavian vein is a method described since 1965, also giving direct access to the innominate vein, a larger vessel which is rarely collapsible regardless of volume status or respiratory efforts. based on a previous pilot trial, in this multi-center, prospective, randomized, controlled trial, the investigators aim to compare the successfulness and safety of ultrasound-guided central venous cannulation at 3 different sites: internal jugular, subclavian, and innominate veins.

Eligibility criteria:
inclusion criteria: * patients who need central venous catheterization, and have respirophasic variation in cross-sectional area of jugular veins exclusion criteria: * less than 18 years-old * patients with previous failed attempts with non-ultrasound guided technique * non-resolved pneumothorax/hemothorax at enrollment * refusal to sign informed consent

Keywords: central venous access ultrasound-guided catheterization innominate vein brachiocephalic vein
a study of rtp-026 to assess safety, tolerability and efficacy in patients with st-elevation myocardial infarction (stemi)

Conditions: ST Elevation Myocardial Infarction

Summary: this is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of rtp-026. the study population will consist of men and women with documented evidence of st-elevation myocardial infarction (stemi) referred to primary percutaneous coronary intervention (pci).

an exploratory, randomized, double-blind, multicentre, placebo-controlled study of rtp-026 to assess safety, tolerability, and efficacy in patients with (stemi). the study population is men between 18-80 years and post-menopausal women up to 80 years with documented evidence of stemi referred to primary pci with acute onset of chest pain lasting \<12 hours and neutrophil to lymphocyte ratio (nlr) in the range of 7-17 at hospital admission/right after the pci. they will be given three 30-minute intravenous infusions of rtp-026 or placebo (the investigational product). the first dose is to be initiated within 2 hours following the establishment of reflow after pci, and the following two study treatments with 8-hour intervals. the purpose of this study is to evaluate the safety, tolerability and efficacy of rtp-026 versus placebo in multiple doses.

Eligibility criteria:
inclusion criteria: * informed consent for participation in the study has been obtained prior to initiating any study-specific procedures * men between 18-80 years of age and post-menopausal women up to 80 years of age * acute onset of chest pain of \< 12 hours duration * stemi as characterized on ecg by 2 mm st elevation in 2 or more v1 through v4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant st elevation or 1 mv st elevation in the limb lead (ii, iii and avf, i, avl) and v4-v6 or st depression in 2 or more v1 through v4 leads indicating posterior acute myocardial infarction (ami) * eligible for primary pci * nlr in the range of 7-17 at hospital admission or right after the pci exclusion criteria: * participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry * previous exposure to rtp-026 * time from symptoms onset to primary pci \> 12 hours * previous cabg * evidence of active malignant disease * ongoing treatment with immune suppressive compounds * any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures * known contraindications to cmr * orbi risk score \> 10
biomarkers to detect endocrine therapy resistance

Conditions: Metastatic Cancer; Breast Cancer; Lobular Breast Carcinoma

Summary: this pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with er/pr+ metastatic lobular breast cancer (lbc) starting new endocrine therapy. 18f-fluorofuranylnorprogesterone positron emission tomography/computed tomography (ffnp-pet/ct) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. baseline levels and dynamic on-treatment changes in estrogen signaling as measured by ffnp-pet/ct and circulating tumor cell (ctc) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.


Eligibility criteria:
inclusion criteria: 1. willing to provide informed consent 2. individuals at least 18 years of age 3. have biopsy-proven er/pr-positive (defined as er ≥1 percent and pr ≥1 percent by ihc) and her2-negative advanced or metastatic lbc starting new standard of care endocrine therapy 4. adequate organ function as indicated by standard laboratory tests (cbc, liver function tests or cmp) allowing for systemic breast cancer treatment per treating oncologist 5. patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible 6. willing to comply with all study procedures and be available for the duration of the study 7. disease may be measurable by recist 1.1 criteria or non-measurable. lesion size must be at least 1cm. if only bone lesions present, they should be lytic or mixed lytic-sclerotic. if only liver lesions present, patient is not eligible. exclusion criteria: 1. patients with active brain metastases 2. patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination 3. unable to lie flat during or tolerate pet/ct 4. patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to ffnp 5. presence of liver failure as judged by patient's treating physician 6. individuals who are pregnant, lactating, or planning on becoming pregnant during the study 7. not suitable for study participation due to other reasons at the discretion of the investigators 8. patients with progesterone-receptor negative disease defined as pr \<1 percent by ihc

Keywords: endocrine therapy resistance circulating tumor cell liquid biopsy
evaluating the effectiveness of strimvelis risk minimization measures (rmms)

Conditions: Severe Combined Immunodeficiency Due to ADA Deficiency

Summary: strimvelis is a medicinal product that restores adenosine deaminase (ada) function in hematopoietic cell lineages, thereby preventing impaired immune function. strimvelis is indicated for the treatment of patients with ada- severe combined immunodeficiency (scid), for whom suitable human leukocyte antigen (hla)-matched related stem cell donor is not available. the objective of this study is to evaluate the effectiveness of routine and additional risk minimization measures by assessing the understanding of referring health care providers (hcps) and parents/carers (hereby referred as participants) with regard to the specific risks associated with strimvelis. in this cross-sectional study, surveys will be provided to referring hcps and parents/carers of children approximately six months after treatment with strimvelis. the study will recruit for approximately two years or until a maximum of 10 referring hcps and 10 parents/carers have completed their respective surveys, whichever occurs first.


Eligibility criteria:
inclusion criteria: * hcps or hcps' close family members may not have been employees of orchard, pharmaceutical product development, llc (ppd), the food and drug administration (fda), or the european medicines agency (ema). * hcps must be licensed * an hcp must not have previously completed a survey regarding strimvelis educational materials. * an hcp must have previously referred a patient for strimvelis treatment. * parents/carers or parents'/carers' close family members may not have been employees of orchard, ppd, fda, or ema. * a parent/carer must not have previously completed a survey regarding strimvelis educational materials. * a parent's or carer's child must have previously received treatment with strimvelis exclusion criteria: * no exclusion criteria

Keywords: human leukocyte antigen key risk message ada-scid health care providers
a novel computer-based therapy for social anxiety

Conditions: Social Anxiety Disorder

Summary: the present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (gc-mrt) in individuals with social anxiety disorder (sad)

the present study is a double blind trial that seeks to examine the feasibility, acceptability, efficacy, and mechanism of a recently developed eye-tracking-based therapy (gc-mrt) in individuals with social anxiety disorder (sad). the purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions twice a week for 4 weeks, helps improve social anxiety symptoms, and by what mechanism. the study will also assess the effect of research treatments on brain activity using a scan called magnetic resonance imaging (mri).

Eligibility criteria:
inclusion criteria: * males and females between the ages of 18 and 60 * current dsm-v primary diagnosis of sad * score of at least 50 on the liebowitz social anxiety scale (self-rated version) * fluent in english and willing and able to give informed written consent and participate responsibly in the protocol * normal or corrected-to-normal vision exclusion criteria: * present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder * current severe depression * suicidal ideation or behavior * current diagnosis of ptsd, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder * current or past organic mental disorder, seizure disorder, epilepsy or brain injury * current unstable or untreated medical illness * severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed) * use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (ssris) for a least 3 months * any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months * pregnancy, or plans to become pregnant during the period of the study - will be assessed by urine β-hcg * contraindication to mri scanning: * paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos) * being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)

Keywords: social anxiety social anxiety disorder sad
the related factors of bariatric surgery on lipidemia

Conditions: Bariatric Surgery; Lipidemia

Summary: obesity and related metabolic diseases have become a chronic disease that is a threat to human health. bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. however, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. long-term gastroesophageal reflux may lead to barrett's esophagus or esophageal cancer. nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise. in this study, prospective randomized controlled trials were conducted to explore the possible change of lipidemia after bariatric surgery and to explore ways to prevent bariatric surgery after bariatric surgery.


Eligibility criteria:
inclusion criteria: -for the choice of surgical approach, numerous studies have shown that bmi ≧ 45, the general choice of gastric bypass surgery, bmi \<45, you can choose sleeve gastrectomy. the remission rate for t2dm, sleeve gastrectomy has a good result for young patients with shorter duration. in the investigator's country, the bmi less than 45 is majorities. exclusion criteria: -bmi\<27.5
clinical study of released unitron ric and bte hearing aid models

Conditions: Hearing Loss

Summary: the present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). participants with mild to severe hearing impairment will be fit binaurally with unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.

each participant will be asked to wear a set of bte and ric hearing aids and complete the hearing in noise test (hint) aided and unaided. the investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the snr50 (the signal-to-noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Eligibility criteria:
inclusion criteria: * adults (18+ years) with hearing impairment (n2 - n6 hearing loss). * healthy outer ear. * symmetrical hearing loss. * ability to answer questions and repeat sentences. * informed consent as documented by signature. * willingness to wear different style of hearing aids. * willingness to wear a binaural fitting. * willingness to wear closed domes. * willingness to adhere to covid protocols including correct mask use, completing screening for each visit exclusion criteria: * contraindications to the medical device (md) in this study (e.g. known hypersensitivity or allergy to the investigational product). * limited mobility/not able to come to scheduled visits. * inability to produce reliable hearing test result. * visible congenital or traumatic deformity of the outer ear. * history of active drainage from the ear in the previous 90 days. * abnormal appearance of the eardrum and ear canal. * acute or chronic dizziness. * audiometric air-bone gap equal to or greater than 15 db at 500 hz, 1000 hz, 2000 hz, and 4000 hz. * known psychological problems.
neuroprotective effect of autologous cord blood combined with therapeutic hypothermia following neonatal encephalopathy

Conditions: Hypoxic Ischemic Encephalopathy; Cerebral Infarction

Summary: this study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. the hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.

the primary aim of this study is to determine the neuroprotective effect of intravenous administration of autologous cord blood in neonates with severe encephalopathy (hypoxic ischemic encephalopathy or cerebral infarction). it is hypothesized that the administration of autologous cord blood will be safe and well tolerated in neonates with severe encephalopathy. if a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate will receive their own cord blood. the cord blood cells are divided into 3 doses and infused at 24, 48, and 72 hours after the birth. infants will be randomised to treatment with autologous cord blood and hypothermia or hypothermia only and followed for safety and neurodevelopmental outcome up to 18 months. all infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants who allocated to hypothermia and xenon will also receive autologous cord blood in 24 hours from birth through a purpose designed delivery system. additionally, postnatal neuro-developmental outcomes in neonates with encephalopathy after autologous cord blood therapy will be measured; hie injury to the neonate/infant brain post autologous cord blood therapy by imaging will be characterized; mri's will be obtained per clinical routine; serum levels of selected cytokine and neurotrophic factors in neonates with hie before and after autologous cord blood therapy will be compared and immune cell phenotype and function in neonates with hie before and after autologous cord blood therapy will be compared.

Eligibility criteria:
inclusion criteria: 1. gestational age ≥ 34 weeks 2. birth weight ≥ 1800 grams 3. 10-minute apgar score ≤5 or continued need for ventilation or severe acidosis, defined as ph \<7.0 4. moderate to severe encephalopathy (sarnat ii to iii) 5. a moderately or severely abnormal background aeeg voltage, or seizures identified by aeeg, if monitored 6. up to 24 hours of age 7. autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth 8. parental informed consent exclusion criteria: 1. known major congenital anomalies, such as chromosomal anomalies, heart diseases 2. major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3. severe intrauterine growth restriction (weight \<1800g) 4. severe infectious disease, such as sepsis 5. inability to enroll by 24 hours of age 6. volume of collected cord blood \<40 ml 7. infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist 8. parents refuse consent
cervical spinal manipulation and visteral osteopathy for mechanical neck pain

Conditions: Neck Pain

Summary: this study compares two treatment techniques, cervical spinal manipulation (csm) and visceral osteopathy (vo), in patients with mechanical neck pain (mnp). the aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.

the purpose of this study is to compare the acute effects of cervical spinal manipulation (csm) treatment and visceral osteopathy (vo) techniques on pain, cervical range of motion (rom), muscle strength, and grip strength in individuals with mechanical neck pain (mnp). the study is going to include a total of 30 subjects aged 18-60 diagnosed with mnp. the subjects are randomly divided into two groups. the csm group received high-velocity, low-amplitude (hvla) spinal manipulation, while the other group underwent vo techniques. each treatment technique is going to be applied in only one session. pain intensity is assessed using the visual analog scale (vas). cervical rom and the craniovertebral angle (cva) are evaluated using a goniometer. neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.

Eligibility criteria:
inclusion criteria: * participants is included if they had neck pain present for at least one week, reduced cervical rom, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck. exclusion criteria: * exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.

Keywords: neck pain treatment visceral osteopathy servical spinal manupilation osteopathy
prehospital analgesia in adults using inhaled methoxyflurane : a feasibility study

Conditions: Pain, Acute; Trauma

Summary: pain is common and can contribute to both psychological and physiological effects if not treated. currently primary care paramedics have limited selections within their pain management tool box. this contributes to inadequate pain management. methoxyflurane is a safe, easy and effective choice in prehospital management of pain. the impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital canadian national guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.

this will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. the feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. a waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. patient \>= 18 years of age with traumatic pain with a verbal score \>= to 4 will be enrolled.

Eligibility criteria:
inclusion criteria: * \>=18 years of age * acute pain from traumatic injury * numeric pain score \>=4 exclusion criteria: * allergy or sensitivity to methoxyflurane * history or family history of malignant hyperthermia * pregnant or breast-feeding patients * known renal impairment * known liver disease * methoxyflurane use within previous 3 months

Keywords: prehospital paramedic ambulance methoxyflurane penthrox penthrane