Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of ph-impedance tracings according to the wingate consensus, and influence on gerd classification according to the lyon consensus

Conditions: GERD

Summary: commonly, in clinical practice an automated analysis of ph-mii tracings is obtained.

all ph-mii performed in uz brussel are already reviewed manually according to the wingate con-sensus and interpreted according to the lyon consensus. in this study, we will prospectively categorise the reasons for discarding reflux episodes identified by automated analysis during the manual review according to the wingate consensus, as well as the impact on different parameters related to the interpretation of ph-mii. based on comments received to our retrospective study, we will evaluate possible confounders to the interpretation, including the indication for referral for ph-mii, symptom severity, use of ppi during ph-mii.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 - 80 years old; * ph-mii performed off ppi exclusion criteria: * prior upper gi endoscopy indicative of structural disease (except for oesophagitis or hiatal hernia). * incomplete ph-mii (less than 21 hours recording); * ph-mii performed on ppi * suboptimal quality of the tracings preventing interpretation in clinical practice; * prior oesophageal (including anti-reflux intervention) or gastric surgery.

Keywords: gerd ph-impedance wingate-consensus lyon consensus
a study of tqb2450 injection combined with anlotinib hydrochloride capsule versus sunitinib in subjects with advanced renal cancer

Conditions: Advanced Renal Cancer

Summary: this study is a randomized, positive parallel controlled, multicentre phase iii clinical trial to evaluate the efficacy and safety of tqb2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.


Eligibility criteria:
inclusion criteria: * 1. histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components. 2. has not receiving systemic therapy for local advanced/metastatic disease. 3. at least has one measurable lesion. 4. eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 5. adequate laboratory indicators. 6. agree to provide at least 5 slices tumor tissue samples for biomarker detection. 7. serum or urine pregnancy tests are negative within 7 days before randomization; men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months. 8. understood and signed an informed consent form. exclusion criteria: * 1. has symptomatic central nervous system (cns) disease and / or cancerous meningitis, pia mater disease. 2. has received anti-angiogenesis targeted therapy or targeted pd-1 and pd-l1 immunotherapy. 3. has active virus, bacteria, fungal infection; cardiovascular and cerebrovascular diseases; gastrointestinal abnormalities; immunodeficiency; bleeding risk; lung disease; neurological or psychiatric disorders. 4. has participated in other clinical trials within 30 days before randomization. 5. has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period. 6. pregnant or lactating women. 7. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
a study to learn about the study medicine (nirmatrelvir plus ritonavir) in pregnant women with covid-19

Conditions: COVID-19

Summary: the purpose of this clinical trial is to learn about how study medicine (paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate covid-19 compared to non-pregnant women with mild or moderate covid-19. this study is seeking participants who: * are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate covid-19 * are not pregnant and have mild or moderate covid-19. all participants in this study will take paxlovid by mouth every 12 hours for 5 days. we will study the experiences of people receiving the study medicine. this will help us decide if the study medicine is safe. all participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date. during this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). the other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary).


Eligibility criteria:
inclusion criteria: * all cohorts: mild-to-moderate covid-19 infection confirmed in sample collected ≤5 days prior to enrollment; onset within 5 days prior to enrollment and presence of ≥1 sign/symptom on the day of enrollment. * cohorts 1\&2: expecting single baby; pregnant in 2nd trimester, 14 0/7 to 27 6/7 weeks of gestational age (cohort 1) or 3rd trimester, ≥28 0/7 and ≤34 6/7 weeks of gestational age (cohort 2), by ultrasound. * all cohorts: otherwise healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study exclusion criteria: * all cohorts: current need for hospitalization or anticipated need for hospitalization in the clinical opinion of the site investigator. * cohorts 1\&2: prior/current major condition or illness of mother/fetus substantially increasing risk of study participation/completion or impacting pregnancy/fetal outcomes in investigator's judgement. * all cohorts: current use of any medications that are highly dependent on cyp3a4 for clearance, and which are contraindicated in combination with nirmatrelvir/ritonavir. * all cohorts: has received or is expected to receive monoclonal antibody treatment, convalescent covid-19 plasma, or anti-viral treatment (eg, molnupiravir) for the current sarscov-2 infection. * all cohorts: participants with moderate to severe kidney impairment

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) pregnancy paxlovid nirmatrelvir
eeg spectrogram, brain vulnerability and pod

Conditions: Postoperative Delirium

Summary: an assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium

postoperative delirium in older people may be contributed to by intrinsic brain vulnerability such as pre-existing dementia. some cognitively intact older people also experience postoperative delirium and in these patients some go on to develop later dementia. the investigators propose that postoperative delirium may be an unmasking of covert brain vulnerability by the dyshomeostasis of the anaesthesia/surgical intervention. in people with dementia or mild cognitive impairment, electroencephalography (eeg) studies have shown slowing of brain wave activity, especially in the back of the brain. processed electroencephalography, using a limited number of channels, is routinely used during anaesthesia to aid assessment of anaesthetic depth of the patient. in this study the investigators will assess the feasibility of acquiring eeg data from the front and back of the brain. the investigators will also explore the data for early signals of brain vulnerability

Eligibility criteria:
inclusion criteria: * ≥ 65 years old * elective, moderate/major, non-neuro, non-cardiac surgery * ability to give informed consent exclusion criteria: * preoperative cognitive impairment * current systemic infection * current use of medication that may modify eeg * history of neurosurgery/significant head trauma * presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, parkinson's disease, intracranial tumours and other significant neurologic disorders * current significant psychiatric conditions such as severe depression. * palliative surgery

Keywords: processed eeg postoperative vulnerability older people brain vulnerability
probiotics in infants with cyanotic congenital heart disease

Conditions: Cyanotic Congenital Heart Disease

Summary: infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. it is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. it is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. this pilot trial is designed to address these two questions.

infants with cyanotic congenital heart disease will be randomly assigned to receive either a placebo or probiotic bifidobacterium infantis. comparisons will be made between the infants receiving the placebo and healthy infants without heart disease and between the infants receiving the placebo and those receiving the probiotic.

Eligibility criteria:
inclusion criteria: * cyanotic congenital heart disease * term infant * born at or transferred to uc davis children's hospital exclusion criteria: * congenital anomalies of the intestinal tract

Keywords: cyanotic heart disease congenital heart disease intestinal microbiota probiotics
comparison of open and closed aspiration in newborns

Conditions: Newborn

Summary: endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. it is one of the painful procedures that most frequently causes stress in intubated newborns.

the aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. there is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.

Eligibility criteria:
inclusion criteria: * newborns monitored with mechanical ventilation * newborn who need suctioning, * newborn who did not undergo painful procedures one hour before aspiration. * hemodynamically stable newborn; exclusion criteria: * newborn with any facial/skull deformities * newborn with chromosomal/genetic abnormalities

Keywords: closed system suctioning open system suctioning pain neonatal intensive care newborn suction
insulin and muscle fat metabolism

Conditions: Overweight and Obesity; Insulin Resistance; Metabolic Disease; Mitochondrial Metabolism; Sedentary Lifestyle

Summary: our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. we will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.


Eligibility criteria:
inclusion criteria: * age 30-55 years * body mass index (bmi) 18-45 kg/m2 * sedentary (\<1 hour of planned exercise per week) exclusion criteria: * regular exercise (\>1 hour of planned exercise per week) * smoking, tobacco or nicotine use within the last 1-year * fasting glucose \>126mg/dl * hypertension (systolic pressure \>140 mmhg or diastolic pressure \>90 mmhg) * chronic metabolic or cardiovascular health conditions * pregnant, nursing, irregular menses or post-menopausal * lidocaine allergy * certain medications * diminished capacity for consent
group-based or individual information about disease and treatment plan

Conditions: Prostate Cancer; Breast Cancer

Summary: the main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients' knowledge level about their disease, planned treatment and common side-effects of the treatment. secondary aims are to investigate if the addition of the educational program increases the likelihood of completing treatment as planned, reduces level of anxiety, reduces the frequency of serious side effects, increases patient reported health related quality of life, and increases the degree of patient satisfaction with respect to how they have received the information before, during and after treatment.

there are strong indications that group-based information provides better information for cancer patients about their disease, treatment options - and potential benefits and side effects of the planned therapy than information provided during a regular doctor consultation. the investigators believe that standardizing and repeating the information as well as having more time for questions in an open environment for reflections will improve the amount of information patients can perceive. furthermore, all patients will be given written information. better-informed patients may be more motivated and may contact health care personnel earlier than other patients when they develop side effects. this may reduce the risk of serious treatment-related complications and increase the chances of patients completing the planned treatment. but none have compared to what extent an organization like vardesenteret improves the patients' knowledge and whether patients are more satisfied with these methods for informing them. results from studies on the influence of patient anxiety and distress on patient's abilities to perceive information are conflicting.two large groups of relatively homogenous cancer patients are patients with lower-stage breast cancer patients who are eligible for adjuvant chemotherapy and patients with localized prostate cancer eligible for curative radiotherapy.

Eligibility criteria:
inclusion criteria: * breast cancer patients that are candidates for adjuvant chemotherapy after surgery. * prostate cancer patients that are candidates for curative radiotherapy * signed informed consent * patient expected to be able to complete the planned treatment and the study procedures * 18years or older exclusion criteria: -patients not fulfilling inclusion criteria

Keywords: patient education information communication
enhancing stability and function in adolescent

Conditions: Patellofemoral Pain Syndrome; Adolescents

Summary: this study investigated the comparative effects of proprioceptive neuromuscular facilitation (pnf) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (pfps).


Eligibility criteria:
inclusion criteria: * participants were between 16 and 18 years old. * patients had to have experienced anterior knee pain for at least 4 weeks, with the pain being exacerbated by at least two of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting (chevidikunnan et al., 2016). * participants could not have undergone any surgical procedures on their lower limbs. * pain during the previous week needed to be greater than 30 mm on a 100 mm visual analogue scale (vas) (appendix i) (rathleff et al., 2015). * a spectrum of bmi was sought, with participants recruited to represent normal bmi percentile categories for both boys and girls. the normal bmi percentile categories for both boys and girls were defined as the 5th percentile to less than the 85th percentile (appendix ii) (king et al., 2012). exclusion criteria: * adolescents with cruciate ligament injuries, meniscal injuries, collateral ligament injuries, and tenderness associated with any of these structures, any intra-articular injury, and tenderness over the iliotibial band, patellar tendon, pes anserine tendons, or evidence of joint effusion. * adolescents with referred pain from the hip or lumbar region, or a known case of articular cartilage damage.
vascular endothelial growth factor (vegf) trap-eye: investigation of efficacy and safety in central retinal vein occlusion (crvo)

Conditions: Macular Edema Secondary to Central Retinal Vein Occlusion

Summary: this is a phase 3 study to determine the efficacy of vegf trap-eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * subjects at least 18 years of age with center-involved macular edema secondary to crvo with mean central retinal thickness ≥ 250 μm on oct * etdrs best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye exclusion criteria: * previous treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.) * prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye * crvo disease duration \> 9 months from date of diagnosis * previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to day 1 * iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Keywords: macular edema retinal vein occlusion crvo vegf trap-eye best-corrected visual acuity regeneron copernicus
photochemical tissue passivation treatment of saphenous vein grafts in cabg

Conditions: Coronary Artery Disease

Summary: early feasibility study of the durvena photochemical tissue passivation (ptp) device for treatment of saphenous vein grafts in participants undergoing elective coronary artery bypass graft (cabg) surgery. study to be conducted outside the u.s.

the photochemical tissue passivation (ptp) treatment of a saphenous vein graft (svg) is indicated for the reduction of intimal hyperplasia and graft failure rate in svgs after coronary bypass graft (cabg) surgery. the primary study objective, in this early feasibility study outside the us, is to characterize the safety profile of the ptp device when used during cabg surgery in participants with multivessel atherosclerotic coronary artery disease (cad). this is a prospective, randomized, within-subject controlled early feasibility study. up to 15 participants with multivessel cad will be recruited for this study and followed for a minimum of 1 year.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, inclusive of release of medical information, and health insurance portability and accountability act (hipaa) documentation. 2. age 21 years or older. 3. planned and scheduled on-pump, arrested heart cabg. 4. two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff. 5. ima graft indicated for the lad. 6. appropriately sized and accessible target coronary arteries, with a minimum diameter of 2 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively. - exclusion criteria: 1. concomitant non-cabg cardiac surgical procedure. 2. prior cardiac surgery. 3. emergency cabg surgery (e.g., cardiogenic shock, inotropic pressure support, intraaortic balloon pump, ecmo). 4. contraindication for on-pump cabg with cardioplegic arrest (e.g., severely calcified aorta). 5. calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization. 6. platelets \< 50,000/mm3 or other evidence of coagulopathy, inr greater than 1.5 in the absence of anticoagulation therapy. 7. infection (wbc ≥12.5 x 103/ml and or temperature ≥100.5°f/38°c). 8. history of cerebral vascular accident (cva) or transient ischemic attacks (tia) within the last 3 months. 9. unwilling or unable to receive blood transfusion. 10. inability to undergo treatment with heparin. 11. participants on dialysis or gfr of \<30 ml/min/1.73m2. 12. primary liver disease with bilirubin, sgot, or sgpt \> 4x upper limit of normal. 13. prior history of allergic reaction to contrast media with anaphylaxis or severe peripheral edema. 14. any medical condition that, in the opinion of the investigator, would compromise the safety of the participant or quality of the study data. 15. pregnancy and nursing or lactating. 16. current, or past participation in a clinical trial within the past 30 days.

Keywords: saphenous vein grafts cabg surgery
ec17 for intraoperative imaging for parathyroidectomy

Conditions: Primary Hyperparathyroidism

Summary: primary hyperparathyroidism is a significant medical and public health problem in the world and affects approximately 100,000 new patients in the united states alone. if left untreated this can lead to renal stones, osteoporosis, fatigue, and depression. the best treatment for primary hyperparathyroidism is surgical parathyroidectomy. however surgical parathyroidectomy can be difficult due to the variant location of the parathyroid glands. up to 5% of patients leave the operating room without surgical cure. primary hyperparathyroidism is an ideal disease to investigate intraoperative fluorescent imaging. this would allow surgeons to identify the parathyroid glands and resect the suspicious parathyroid glands. folate receptor (fr) has been found to be over-expressed in parathyroid tissue and not thyroid issues. an ideal surgical treatment would combine fr-specific fluorescent tracers with intraoperative imaging. it is important to note that fr is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. thus, the false positive detection rate is expected to be extremely low. a group well known to us in the netherlands has completed a pilot study utilizing a folate-fitc conjugate in 12 patients with ovarian cancer. another group of investigators in mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). they report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). all side effects reversed when the injection was halted. patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin). a fluorescent contrast agent (folate-fitc or ec17) will be used to determine if it will localize to the primary tumor nodule(s) or mass(es) of patients undergoing parathyroid surgery.


Eligibility criteria:
inclusion criteria: 1. adult patients over 18 years of age 2. patients presenting with primary hyperparathyroidism presumed to be resectable on pre-operative assessment 3. good operative candidate 4. subject capable of giving informed consent and participating in the process of consent. exclusion criteria: 1. pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery 2. patients with a history of anaphylactic reactions to folate-fitc or insects 3. vulnerable patient populations 1. homeless patients 2. patients with drug or alcohol dependence 3. children and neonates 4. patients unable to participate in the consent process

Keywords: primary hyperparathyroidism parathyroid