Kornimate/medical-research-clean huggingface dataset:
a study to evaluate d-0502 in subjects with er+ her2- locally advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of d-0502 in the treatment of subjects with er-positive, her2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.


Eligibility criteria:
inclusion criteria: * subjects pathologically confirmed with er-positive, her2-negative breast cancer; * subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy; * presence of at least 1 measurable lesion that can be measured by ct or mri based on recist v1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions \[osteolytic or mixed (osteolytic + osteogenic) bone lesions\] are also acceptable. lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination; * expected survival time ≥ 12 weeks; exclusion criteria: * subjects with unstable or symptomatic or progressive central nervous system (cns) metastases. subjects with a history of brain metastases who are clinically stable and have no cns disease progression confirmed by brain mri or ct (if mri is not appropriate) can be enrolled (mri or ct examination must be conducted at least 4 weeks after the last brain radiotherapy); * subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy; * subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion; * subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases; * prior treatment with a selective estrogen receptor degrader (serd)/selective estrogen receptor covalent antagonist (serca), such as fulvestrant, gdc-9545, azd9833, sar-439859, zn -c5, lx-039, hs234, etc.; * pregnant or lactating females;
effect of acupuncture on postoperative ileus after gastric surgery (eapig)

Conditions: Ileus

Summary: postoperative ileus (poi) is a common problem after major abdominal surgery. acupuncture is being accepted in the west as a treatment option for managing poi and various functional gastrointestinal disorders. therefore, we conducted a prospective randomized pilot study to evaluate the effect of electro-acupuncture on poi and other surgical outcomes in patients who underwent gastric surgery for a later large-scale study.

before surgery, patients were randomized (using simple randomization) to either acupuncture (a) group or non-acupuncture (na) group. in both groups, sitz markers were inserted in duodenum or jejunum during surgery for detection of postoperative remnant sitz markers by xray. in the a group, acupuncture treatment was given once daily for up to 5 consecutive days starting on postoperative day 1. the acupuncture points which were used were based on traditional korean medicine. no acupuncture treatment was performed in the na group.

Eligibility criteria:
inclusion criteria: * patients undergoing elective surgery for gastric cancers * patients with american society of anesthesiologists grades i-iii * patients who provided written informed consent exclusion criteria: * patients who developed intraoperative problems or complications * patients with contraindications to had electrical stimulation devices (pacemaker or implantable defibrillator) * patients who were allergic to acupuncture needle

Keywords: acupuncture gastric cancer
product validation study of 2 new devices, ez-ng (rightspot ph indicator) and ez-ph (rightlevel ph indicator)

Conditions: Small Bowel Obstruction; Colectomy; Bowel Surgeries

Summary: ez holdco inc. has developed two devices for the measurement of gastric content ph. the devices, ez-ng and ez-ph, rapidly check gastric ph by aspirating gastric contents into the device through a nasogastric (ng) tube and causing a color change in the device. the color change is then compared to the reference indicator on the device to determine a ph value of the aspirate. currently there is no bedside rapid way to check gastric ph that protects the clinician from being exposed to the aspirate. 1. primary objective to assess the accuracy of the ph measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved ph probe. 2. secondary objective to determine what percentage of time the ez-ng - rightspot ph indicator could have been used to determine proper placement of the ng tube when initially placed.


Eligibility criteria:
inclusion criteria: * consented elective surgical patient exclusion criteria: -
lt vaccine patch self-administration study

Conditions: Prevention of Travelers' Diarrhea

Summary: to evaluate the immune responses achieved following self-administered heat-labile enterotoxin of e. coli (lt) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible to participate in the study: * healthy adult males or females 18-64 years of age with signed informed consent. * women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and iud. exclusion criteria: subjects meeting any of the following criteria are not eligible for participation in the study: * laboratory abnormalities \[as determined by the toxicity grading scale (grade 1-4)\] at laboratory screening * abnormalities at physical examination \[as determined by the toxicity grading scale (grade 1-4)\] * known allergies to any component of the vaccine * known allergies to adhesives * participated in research involving investigational product within 30 days before planned date of first vaccination * donated blood or blood products such as plasma within the past 30 days * ever received investigational enterotoxigenic e. coli, lt, or lt (r192g) or nasalflu, berna biotech, ltd * ever received cholera toxin or vaccine (e.g. orochol™, dukoral™) * history of traveler's diarrhea in the previous two years * history of abdominal surgery (excluding c-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (gi) illness * positive serology for hiv-1, hiv-2, hbsag, or hcv * medical history of acute or chronic skin disease at vaccination area(s) * active skin allergy * signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation * excessively hirsute at the vaccination area(s) that would interfere with patch adhesion in the opinion of the investigator * visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s) * fever greater than or equal to 38.0°c (100.4°f) at the time of planned vaccination * women who are pregnant or breastfeeding * acute illness at screening or at baseline; or * employee of the investigational site.
evaluating peanut immunotherapy dissolving film in healthy subjects

Conditions: Peanut Allergy; Immunotherapy; Pharmacokinetics

Summary: open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

in this study, 15 non-peanut allergic children and adults will be enrolled. at three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. concentrations of ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by elisa.

Eligibility criteria:
inclusion criteria: * age ≥ 3 years and \<30 years. * able to give informed consent. * english speaking with no language impairment * regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months exclusion criteria: * history of reaction to peanuts * major active medical problems of the oral cavity or use of medications that might change rates of salivation
study to evaluate safety and tolerability of pegaptanib sodium in patients with diabetic macular edema

Conditions: Anti- VGF Inhibitor; Diabetic Macular Edema; Diabetic Retinopathy

Summary: this study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. the hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.


Eligibility criteria:
inclusion criteria: * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * subjects with documented clinical diagnosis of diabetic macular edema (dme) with proliferative or non proliferative diabetic retinopathy. * subjects, who according to the clinical assessment of the investigator, may benefit from anti-vegf therapy including those subjects who were participating in the a5751013 study and who, in the investigator's opinion, may benefit from continued pegaptanib sodium therapy. exclusion criteria: * eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months. * presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for \>1 disc area involving the foveal avascular zone (faz - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy involving the center of the macula. * vitreomacular traction determined clinically and/or by optical coherence tomography (oct), which, in the investigator's opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium. * any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.

Keywords: pegaptanib sodium diabetic macular edema
a study to investigate the effect of mirabegron (ym178) on subjects with mild or moderate hepatic impairment compared to healthy subjects

Conditions: Pharmacokinetics; Healthy Subjects; Mild and Moderate Hepatic Impairment

Summary: the study aims to investigate and compare the effect of mirabegron (ym178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.

healthy subjects and subjects with mild and moderate hepatic impairment are admitted on day 1. subjects receive a single oral dose of mirabegron in the morning of day 1 and will remain in the unit till day 5 with outpatient visits on days 6 and 7 for healthy subjects and days 6, 7, 9 and 11 for subjects with hepatic impairment. blood sampling for pk assessment will be up to 144 hrs post dose for healthy subjects and up to 240 hrs post dose for subjects with hepatic impairment. an additional blood sample was obtained for all subjects 4 hrs post dose for protein binding.

Eligibility criteria:
inclusion criteria: * body mass index more than or equal to 18.0 and less than 32.0 kg/m2 (men and women) * subject is genotyped as an extensive metabolizer for cyp2d6 * for subjects with mild/moderate hepatic impairment: hepatic dysfunction scored as mild impairment ((between 5-6 in the child-pugh's classification) and moderate impairment (between 7-9 in the child-pugh's classification) * healthy subject with normal hepatic function exclusion criteria: * known or suspected hypersensitivity to mirabegron or any components of the formulations used * a marked prolongation at screening of qt/qtc interval demonstrated by a mean qtcf interval \>450 ms for male subjects and a mean qtcf interval \>470 ms for female subjects (based on 3 ecgs) * abnormal pulse rate and/or blood pressure measurements at the pre-study visit taken in triplicate by means of an automatic device, after subject has been resting in supine position for 5 min: •pulse rate \ 90 bpm; mean systolic blood pressure \ 160 mmhg; mean diastolic blood pressure \ 95 mmhg * healthy subjects: use of any prescribed or otc drugs (except paracetamol, with a maximum of 3g/day) in the 2 weeks prior to admission to the clinical unit

Keywords: pharmacokinetics mirabegron hepatic impairment phase 1
echocardiographic assessment of volume variation secondary to preoperative fasting

Conditions: Hypovolemia

Summary: the primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% δitv during a leg lift) in patients undergoing surgery.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is asa (american society of anesthesiologists) class i, ii or iii * the patient has not been fasting for more than 6 hours at the time of inclusion * the patient is schelduled for a gynecological or visceral surgery exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * the patient is asa class iv * the patient has insulin dependent diabetes * the patient has a cardiac or respiratory dysfunction * the patient has a heart rhythm disorder * the patient has renal insufficiency with dialysis * the patient is being treated with diuretics * the patient has had a bowel preparation * emergency surgery * outpatient surgery

Keywords: preoperative fasting
effect of intermittent oro-esophageal tube vs nasogastric tube in tracheostomized patients with intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: this was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with intracerebral hemorrhage transferred to the department of rehabilitation medicine of 4 hospitals in china between january 2023 to june 2023. the goal of this clinical trial is to compare the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage. the main questions it aims to answer are: compared to nasogastric tube feeding, can the intermittent oro-esophageal tube feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of patients with intracerebral hemorrhage compared to nasogastric tube feeding, is the intermittent oro-esophageal tube feeding safer. participants will be divided into two groups randomly, with different nutritional support respectively. .

safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. nasogastric tube feeding has been the mainstay in china but has a significant risk of adverse events. intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace nasogastric tube feeding. this study reports the clinical effect of intermittent oro-esophageal tube feeding vs nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy. however, in the field of intracerebral hemorrhage combined with tracheostomy, research on intermittent oro-esophageal tube feeding is still relatively limited. therefore, this study was carried out to explore the clinical effect of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for intracerebral hemorrhage. * with placement of a tracheotomy tube. * requiring enteral nutrition support. * age over 18 years. * able to cooperate with treatment and questionnaire investigation, (generally with a mini-mental state examination (mmse) score ≥ 24) . exclusion criteria: * combined with tumors in the head, neck, esophagus, or gastrointestinal tract * an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus * with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys * with severe hemorrhagic disease or bleeding tendency; 5) with contraindications for enteral nutrition * with dysphagia caused by non-stroke-related reasons in the past
sustained effects of thoracocentesis in mechanically ventilated patients

Conditions: Pleural Effusion

Summary: collections of fluid around the lung (pleural effusions) are common in patients on mechanical ventilation. long stays on mechanical ventilation can lead to serious complications such as pneumonia and are associated with significant morbidity and mortality. the drainage of pleural effusions may lead to improvements in oxygenation making it easier to discontinue mechanical ventilation. the purpose of this study was to examine the effects of thoracocentesis (pleural fluid drainage) on blood oxygenation over a 48 hour period to see whether the effects are sustained and therefore helpful in this discontinuation.

this will be a collection of data in patients in whom it has been decided by the attending clinician that pleural drainage would be beneficial. ultrasound will be used to confirm the presence of pleural effusion and to estimate the size of the pleural effusions and to confirm the position of the pleural drain. data will be collected before drainage, 30 minutes after drainage and then at 4,8,12 and 24 hours after the insertion of the drain (please see also attached summary of investigations). measurements will include arterial blood gas analysis drawn from an indwelling arterial catheter, blood pressure, pulse, respiratory rate, mixed, expired co2 and ventilator settings. the measurements will stop either at the end of the 48 hour period or when the team caring for the patient chose to remove the drain (whichever is the first). all measurements including the arterial blood gas analysis form part of the standard care of an icu patient. the arterial blood gas measurements are withdrawn from an indwelling arterial catheter which is routinely in place on all icu patients. only the use of thoracic ultrasound by a trained ultrasonographer both before and after the procedure will be additional to the standard care of the patient. the use of chest x-rays is at the discretion of the treating clinician and does not form part of the study protocol. standard biochemical, microbiological and cytological tests will be performed on the pleural fluid and blood in keeping with the standard practice for pleural effusions. the primary outcome measure is the effects of drainage on the p:f ratio. measures of dead space ventilation, a-a gradiants, ventilator settings and dynamic compliance will also be assessed

Eligibility criteria:
inclusion criteria: * patients on mechanical ventilation with evidence of pleural effusions on plain cxr confirmed to be large on bedside ultrasound in whom the attending clinician felt drainage would be beneficial exclusion criteria: * coagulopathy

Keywords: ventilation oxygenation
wedge resection for ground-glass opacity-featured lung cancer (ectop-1020)

Conditions: Lung Cancer; Wedge Resection; Ground-glass Opacity

Summary: this is a clinical trial from the eastern cooperative thoracic oncology project (ectop), numbered as ectop-1020. the goal of this clinical trial is to confirm the therapeutic effect of wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.


Eligibility criteria:
inclusion criteria: 1. patients who sign the informed consent form and are willing to complete the study according to the plan; 2. aged from 18 to 80 years old; 3. ecog equals 0 or 1; 4. not receiving lung cancer surgery before; 5. intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma; 6. single lung nodules with ground-glass dominant or pure ground-glass on ct, or multiple lung nodules with the major lesion being the aforementioned nodules; 7. the nodule has a consolidation-to-tumor ratio (ctr) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm; 8. peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field. 9. ct1n0m0 tumors; 10. complete tumor resection by wedge resection as assessed by the surgeon; 11. not receiving chemotherapy or radiotherapy before. exclusion criteria: 1. postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma. 2. ctr is not between 0.25-0.5 or nodule size greater than 2 cm; 3. cannot be completely resected by wedge resection; 4. invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically; 5. receiving lung cancer surgery before; 6. receiving radiotherapy or chemotherapy.