Kornimate/medical-research-clean huggingface dataset:
a study of ipatasertib plus palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in hormone receptor positive and her2 negative locally advanced unresectable or metastatic breast cancer

Conditions: Breast Cancer

Summary: the open-label phase ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the phase iii portion. the randomized phase iii portion of this study will evaluate the efficacy, safety, and patient-reported outcome (pro) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with hr+ her2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * hr+ her2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic * for women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs * for men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm * radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1l endocrine therapy in locally advanced unresectable or metastatic breast cancer * at least one measurable lesion via response evaluation criteria in solid tumors, version 1.1 * phase iii only: tumor specimen from the most recently collected, available tumor tissue exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant * prior treatment with fulvestrant or other selective estrogen receptor down-regulator * prior treatment with pi3k inhibitor, mtor inhibitor or akt inhibitor * phase iii only: prior treatment with cdk4/6 inhibitor for locally advanced unresectable or metastatic breast cancer * prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer * history of type i or type ii diabetes mellitus requiring insulin * history of or active inflammatory bowel disease or active bowel inflammation * lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections
china chronic cough registry: a multicenter, prospective, observational study

Conditions: Chronic Cough (CC)

Summary: the aim is to establish a national clinical database and biobanks for chronic coughers. through real-world chronic cough case registry and follow-up studies, we will explore the clinical phenotypes and molecular subtypes of chronic cough.

there is currently no national cohort study on chronic cough in china. preliminary researches indicated heterogeneity in the clinical phenotypes and hypersensitivity associated with chronic cough, highlighting the need to establish a large chronic cough cohort for further study. the completion of this project will provide real-world data for the management of chronic cough patients, contributing to the improvement of prevention, treatment, and management standards. it will also provide chinese data for further refining cough guidelines. additionally, by elucidating the phenotypes and molecular subtypes related to chronic cough, this study will be significant for identifying relevant targets to guide new drug development for chronic cough. this multicenter, prospective, observational study will enroll patients with chronic cough in a real-world clinic. baseline information including demographics, cough characteristics, past treatment history, laboratory test results, initial diagnosis and treatment details will be recorded by using an online registration and follow-up platform. after the baseline data registration, we will conduct annual follow-ups for these patients over a period of two years. the cough prognosis and medication using history will be recorded at every follow-up. some patients will provide biological samples such as sputum supernatant, serum, etc at baseline and follow-up. the diagnosis and treatment process for these patients is based on clinical practice/guideline standards, without any other interventions.

Eligibility criteria:
inclusion criteria: * is over 18 years old * cough as the sole or main symptom * has cough lasting more than 8 weeks * no obvious findings of chest x-ray / chest ct * has no other evident diagnoses (e.g. ipf, ncfb, copd, bronchiectasis, lung cancer) * has given signed consent for inclusion in the study exclusion criteria: -

Keywords: chronic cough registry clinical data biosample
b-turp vs bipolep in management of bph patients with medium-sized prostates

Conditions: Benign Prostatic Hyperplasia

Summary: this is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates

benign prostatic hyperplasia (bph) is a highly prevalent condition among aging males, with incidence rates escalating progressively with age. epidemiological data indicate that approximately 8% of men in their fourth decade are affected, a proportion that rises to 50% by the sixth decade and exceeds 80% in individuals reaching their ninth decade. bph may induce bladder outlet obstruction (boo), leading to lower urinary tract symptoms (luts). luts are one of the most frequent urological complaints in aging males. luts are typically categorized into obstructive and storage subtypes, with clinical bph representing the predominant underlying etiology. approximately 20% of men with bph will eventually require surgical intervention. transurethral resection of the prostate (turp) remains the gold-standard surgical treatment, offering both immediate relief of intravesical obstruction and durable improvement in voiding parameters and symptoms. however, the procedure carries significant risks, including perioperative bleeding and transurethral resection syndrome (tur syndrome), with complication rates increasing proportionally to prostate size. the recent technological advancements in urological equipment have led to increased adoption of bipolar transurethral resection of the prostate (b-turp) for bph management. this technique employs a plasma kinetic system that provides superior coagulation capabilities. a significant advantage of b-turp is its use of normal saline irrigation, which substantially reduces the risk of tur syndrome compared to conventional methods. clinical studies have demonstrated b-turp's efficacy in relieving bladder outlet obstruction secondary to bph, with outcomes comparable to traditional approaches. despite advancements in turp technology, incidence of complications such as postoperative recurrence remained unchanged, necessitating surgical innovation. in this context, bipolar enucleation of the prostate (bipolep) has emerged as an alternative technique designed to address these challenges. our study was designed to conduct a comparative analysis of bipolep versus bipolar b-turp in the treatment of medium-sized bph patients.

Eligibility criteria:
inclusion criteria: * male patients aged 45-80 years with symptomatic bph (ipss ≥8). * prostate volume between 40-80 cc as determined by transrectal ultrasound (trus). * failure of medical management. * written informed consent. exclusion criteria: * prostate cancer (suspected on psa/dre or confirmed by biopsy). * previous prostate/urethral surgery. * neurogenic bladder or urethral strictures. * significant coagulopathy. * uncontrolled urinary tract infection. * patient on anticoagulant medication.

Keywords: benign prostatic hyperplasia (bph) bipolar enucleation of the prostate (bipolep) bipolar transurethral reaction of the prostate (b-turp)
establishment and validation of an early diagnostic model for bladder cancer based on serum and urine metabolomics

Conditions: Bladder Cancer

Summary: metabolomics is a complementary approach for identifying perturbed metabolic pathways. the goal of this study is to establish and validate an early diagnostic model for bladder cancer by metabolomics.

early diagnosis and life-long surveillance are clinically important to improve the long-term survival of bladder cancer patients. currently, a noninvasive biomarker that is as sensitive and specific as cystoscopy in detecting bladder cancer is lacking. metabolomics are small organic molecules (below 2000 mass units) that are products of complex pathways. this is a prospective study aims to create an early diagnostic model based on serum and urine metabolomics. commonly employed metabolomics analytical platforms include nuclear magnetic resonance spectroscopy (nmr), gas chromatography mass spectrometry (gc-ms), and liquid chromatography mass spectrometry （lc-ms）. the diagnostic model will be made to distinguish bladder cancer and benign disease of the urinary system.

Eligibility criteria:
inclusion criteria: bladder cancer group: 1. any male or female patient aged 18 or older 2. able to provide serum and urine specimen before treatment 3. diagnosis with incident or recurrent bladder cancer control group 1. any male or female patient aged 18 or older 2. able to provide serum and urine specimen before treatment 3. diagnosis with benign disease of the urinary system, such as urinary calculi and benign prostatic hyperplasia. exclusion criteria: 1. kidney and liver dysfunction. 2. incomplete clinical information and laboratory test result 3. tumor-related treatment was received preoperatively 4. preoperative routine examination and medical history indicate a history of diabetes, hyperlipidemia and other metabolic diseases or other malignant tumors

Keywords: bladder cancer metabolomics
safety of somatropin and induction of puberty with 17-beta-oestradiol in girls with turner syndrome

Conditions: Genetic Disorder; Turner Syndrome

Summary: this trial is conducted in europe. the aim of this trial is to assess whether increasing doses of somatropin (norditropin®) can maintain the initial increase in height velocity and improve final height. this trial has two trial periods, a main period of 4 years and an extension period until final height is reached.


Eligibility criteria:
inclusion criteria: * turner syndrome * well documented growth rate during the previous year * height below the 50th percentile for the age in dutch children * normal thyroid function exclusion criteria: * any endocrine or metabolic disorder * growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias * patients with hydrocephalus
efficacy and safety of app13007 for treatment of inflammation and pain after cataract surgery including a corneal endothelial cell sub-study

Conditions: Ocular Inflammation and Pain After Cataract Surgery

Summary: this phase 3 study will evaluate app13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. the subjects will have undergone routine cataract surgery on day 0 of the study and will be assessed the next day (post-operative day; pod1) after uncomplicated surgery for eligibility for randomization to study treatment. the study comprises the main study and the endothelial cell sub-study.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logmar) in the study eye to be operated and contralateral eye as measured using an early treatment diabetic retinopathy study (etdrs) chart at visit 1. * willing and able to comply with study requirements and visit schedule. * provide signed and dated informed consent. exclusion criteria: * have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures * have an acc count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the screening visit * have a grade \> 0 on the ocular pain assessment in either eye at the screening visit note: other inclusion/exclusion criteria apply.
quality of cardiopulmonary resuscitation pre- and intra hospital

Conditions: Cardiac Death; Cardiac Arrest; Cardiac Arrhythmia; Cardiac Disease

Summary: the survival after intrahospital cardiac arrest has been reported to 15%. in norway this varies between 16 and 23%.). many factors are associated with survival after cardiac arrest, both intra- and prehospital. recent studies have not included information about individual patient factors and the outcome after cardiopulmonary resuscitation (cpr). in the current hospital, we are able to record patient specific information related to a cardiac arrest/cpr situation, and thereby be able to assess patient-related factors associated with both detection, treatment and outcome of cpr.

several factors have been associated with survival, e.g. to monitor hands-off time(odds ratio, or, for 2.48, 95% ki 1.11-5.56, p=.03), monthly assessment of all cardiac arrest cases (or 6.9, 95% ki 1.41-33.92), and includin av local coordinator for cpr (or 2.93, 95% ki 1.08-7.94, p=.03), as well as depth of compressions. nevertheless, information about cardiac arrests and cpr have not been assessed in relation to patient specific information. in the current hospital, we are able to record the cpr sequence, and see this in relation to other patient- and case- specific information such as initial cardiac rythm, time to first compression, hands-off time, quality of cpr, and factors affecting the treatment and outcome. the hospital has 71 registered defibrillators used in cpr. the current study will both gather retrospective data- not seen in relation to patient specific information, and prospective data related to specific patients.

Eligibility criteria:
inclusion criteria: * cardiac arrest (all reasons) * a defibrillator has been used * over 18 years * cardiopulmonary resuscitation has been conducted exclusion criteria: n/a

Keywords: cardiopulmonary resuscitation defibrillation ventilation quality mortality morbidity
correlation between in-vivo anatomy of corneal dystrophies as assessed by high- resolution optical coherence tomography (oct) measurement and histological examination

Conditions: Corneal Dystrophy

Summary: corneal dystrophies are usually classified histopathologically according to the layer of the cornea that is affected. the international committee for the classification of corneal dystrophies (ic3d) takes this anatomical classification as referral with summarizing clinical, genetic, and pathological data. most of this classification relies on slit lamp findings or histologic specimen, since in-vivo imaging of corneal microstructures has only become available in the recent years. with confocal microscopy it is possible to image corneal microstructures at a high resolution, but this technique is limited by its reduced repeatability and the fact that only a small area can be imaged. by the use of optical coherence tomography (oct) systems it is possible to overcome these limitations. commercially available systems, however, only have an axial resolution of about 18 µm which is not sufficient for imaging of all corneal layers. recently, a high-resolution optical coherence tomography (oct) system was developed at the center for medical physics and biomedical engineering that enables a resolution of about 1 µm. with this resolution, all corneal structures and several pathologies can be visualized. in the present study the investigators want to use this oct system to image corneal dystrophies in patients scheduled for corneal transplantation.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * presence of corneal dystrophy * scheduled for corneal transplantation (pk, alk, dalk, dsaek or dmek) * no previous corneal surgery in the study eye exclusion criteria: * participation in a clinical trial in the previous 3 weeks * presence of any abnormalities preventing reliable measurements as judged by the investigator * pregnancy, planned pregnancy or lactating
length of the femoral stem in arthroplasty done for patients with proximal femoral metastatic lesion

Conditions: Metastatic Bone Tumor; Pathological Fracture; Arthroplasty

Summary: proximal femoral metastatic disease is a common cause of morbidity and mortality in cancer patients.protecting the entire femur using long nail or long femoral stem was hypothesized to prevent future fracture.however we believe that long stem isn't always necessary and won't decrease the complication rate.noting it's increased complication rate in this high risk patient category .

skeletal metastasis is the third most common site of cancer metastasis after the lungs and liver, almost all patients with metastatic prostate cancer will have bone metastasis. and about 90% of patients dying from breast cancer has skeletal metastasis. the most common site to which cancer metastasize to long bones is the proximal femur, especially to the intertrochanteric region and femoral neck, contributing to increasing incidence of impending and pathologic fractures of this site.(8) recent advances in cancer treatment increased the longevity of patients, with subsequent increase in morbidity of metastatic disease and increased number of patients living longer with this condition . to date, long femoral stem is most frequently used in cases of pathological and impending proximal femoral fractures. its use is believed to add more stability and prophylactically protect the entire femur from newly developed distal lesions. however, long stems has more operative time, more cardiopulmonary complications and are more technically demanding compared to standard femoral stems arthroplasty.(5) recent retrospective study by xing et al reported comparable outcomes between standard, medium and long stems and concluded that the routine use of long stems is unjustified.another recent report by joel et al investigated the use of long femoral stem in 22 limbs, they reported no hardware failure with no cases of intraoperative cardiopulmonary complications, however they recommended larger comparative trials with rigorous methods to investigate the functional outcomes and complications of long femoral stems in proximal femoral metastatic lesions. in face of the potential advantages in this patient population, the goal of this study is to investigate the use of standard length femoral stems and its results compared to long femoral stems in proximal femoral metastasis .

Eligibility criteria:
inclusion criteria: * pathological or impending pathological pertrochanteric or neck femur fracture, regardless of the presence of distal femoral metastasis. exclusion criteria: * previous arthroplasty in the same side. fractures or lesions involving the subtrochanteric region pathological fracture due to metabolic disease

Keywords: pathological, metastasis , cement reaction long stem
a clinical trial to assess the efficacy and safety of jmt103 in patients with refractory hcm

Conditions: Hypercalcemia of Malignancy

Summary: the purpose of this study is to determine the potential of jmt103 to treat hypercalcemia of malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates.

this is a phase i/ii, single arm, open label, multi-center clinical trial to assess the efficacy and safety of jmt103 in patients with refractory hypercalcemia of malignancy.

Eligibility criteria:
inclusion criteria: 1. fully informed and signed informed consent. 2. male or female, adults (\>/=18 years). 3. hypercalcemia of malignancy (hcm) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (csc) \> 12.5 mg/dl (3.1 mmol /l). 4. last iv bisphosphonate treatment must be \>/= 7 days and \ /= 24 hours before the screening corrected serum calcium（incompatible bisphosphonate）. 5. adequate organ function. exclusion criteria: 1. pregnancy. 2. hyperparathyroidism, or other granulomatous disease. 3. hepatitis b surface antigen positive. 4. hepatitis c antibody positive, or hiv antibody positive. 5. receiving dialysis for renal failure. 6. known sensitivity to jmt103 composition. 7. treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of screening csc. 8. treatment with cinacalcet within 4 weeks prior to the date of screening csc. 9. currently participating another clinical study，or four weeks or less since receiving an investigational product in another clinical study. 10. in the opinion of the investigator , being unsuitable for inclusion in the study，or subjects withdraw informed consent. 11. treatment with monoclonal antibody to rank ligand (rankl) within 180 days prior to the date of the screening csc.
automated algorithm based analysis of phonocardiograms of newborns

Conditions: Heart Murmurs; Mitral Valve Prolapse; Systolic Murmurs

Summary: the purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (caa)). each patient is auscultated and diagnosed independently by a medical specialist. additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. the caa results are compared to the findings of the medical professionals as well as to the echocardiogram findings. hypothesis: the specific (locked) caa algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.

the following registry procedures and quality factors have been implemented: * quality assurance plan, including * data validation * proper registration procedures * regular site monitoring * regular auditing * data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. * source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms). * standard operating procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. * sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. * statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan. * plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Eligibility criteria:
inclusion criteria: * any premature baby or newborn * parental approval for study participation exclusion criteria: * none

Keywords: computer aided auscultation (caa) phonocardiogram analysis murmur detection heart auscultation