Kornimate/medical-research-clean huggingface dataset:
phase ii study of efficacy and safety of hsk39297 tablet in treatment of patients with primary igan

Conditions: IgA Nephropathy (IgAN)

Summary: evaluate the efficacy and safety of hsk39297 tablets in patients with primary igan


Eligibility criteria:
inclusion criteria: 1. subjects must have signed and dated an irb/iec approved written informed consent form.subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study. 2. female and male patients above 18 years of age. 3. patients must weigh at least 35 kg to participate in the study, and must have a body mass index (bmi) below 35 kg/m2. bmi = body weight (kg) / \[height (m)\]2 4. subjects with a biopsy-verified iga nephropathy and where the biopsy was performed within the prior five years. 5. urine protein ≥0.75g/24hr or fmv upcr≥0.8g/g at screening. 6. measured glomerular filtration rate (gfr) or estimated gfr (using the ckd-epi formula 2021) ≥30 ml/min per 1.73 m2. exclusion criteria: 1. use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer. 2. all transplanted patients (any organ, including bone marrow). 3. history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 4. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. 5. pregnant or nursing (lactating) women. 6. plasma donation (≥ 400ml) within 12 weeks prior to first dosing.
prevention of gastrostomy-related wound infection by vancomycin in carriers of methicillin-resistant staphylococcus aureus.

Conditions: Wound Infection

Summary: the aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (mrsa).

percutaneous endoscopic gastrostomy (peg) provides an enteral route for long-term nutrition in patients unable to swallow. peristomal wound infection occurs in 5 - 30 % of patients. systematic antibiotic prophylaxis by cephalosporins or ampicillin/clavulanic acid has been shown to prevent this complication efficiently. mrsa-positive patients have been suggested to be at higher risk of peg-related wound infection due to mrsa. however, recommendations about vancomycin-prophylaxis before surgical procedures have not been extended to peg insertion. this might be due to the fact that the exact route of contamination is unknown. it is assumed that contamination occurs when gastrostomy tubes are passed through the oropharynx. however, oropharyngeal carriage appears less frequent than nasopharyngeal or cutaneous carriage. furthermore, patients who receive peg are particularly vulnerable to vancomycin toxicity because of older age and multiple comorbidities. the aim of this study is to compare the rate of infectious complications after peg insertion in patients colonized with mrsa who received either standard intravenous antibiotic prophylaxis associated with vancomycin or standard prophylaxis with placebo.

Eligibility criteria:
inclusion criteria: * peg insertion in a patient with a swab positive for mrsa during the 4 weeks preceding peg insertion exclusion criteria: * age \< 18 years * no informed consent obtained either from the patient or from his legal representative * contraindication to the administration of cefazolin or of vancomycin * systemic administration of antibiotics effective against mrsa during the week prior to the procedure * technique of peg insertion different from the standard pull technique proposed by the physician in charge and the gastroenterologist * patients requiring antibiotic prophylaxis of endocarditis

Keywords: gastrostomy wound infection antibiotic prophylaxis
trial to assess the efficacy and safety during convective radiofrequency water vapor thermal therapy (rezum) for benign prostate hyperplasia

Conditions: Benign Prostate Hypertrophy(BPH)

Summary: the primary aim of the study is to show that methoxyflurane-lorazepam-percocet combination administrated 'per os' is non inferior to deep intravenous sedation in achieving analgesia during rezum convective radiofrequency water vapor thermal therapy for the management of benign prostate hyperplasia (bph). we propose to conduct a single-centered, unblinded, randomized controlled trial designed after consulting ich guidelines for good clinical practice as well the regulations set by the biomedical research ethics board, university of manitoba.

participants who belong to the experimental arm will be given a single 'per os' dose of percocet (325mg acetaminophen + 7.5mg oxycodone) and lorazepam 1 mg, 30 minutes prior to the procedure. patients will receive education on how to use the penthrox inhaler device. inside the operating room, the subject would self-inhale the methoxyflurane 5 minutes prior to the procedure. all these steps will be supervised by the clinical research nurse. each participant will be administered with 3ml of methoxyflurane which is poured into the inhaler. participants who were randomized to the control arm will receive deep intravenous sedation under the supervision of a trained anesthetist. a combination of midazolam, ketamine, remifentanil and propofol will be administered using an intravenous line. the quantity of these medications will be calculated by the anesthetist based on clinical judgement and also takes into account the physical characteristic of the subject. both the groups receive the same rezum water vapor therapy and the number of rezum injections depends on the clinical judgement of the urologist performing the procedure. immediately, post the procedure, the self-reported pain of the patient will be recoded using the nrs. a phone call follow-up would be done the following day to record any adverse events caused due to the procedure. four weeks post the procedure, a phone call follow-up would be done to understand the patient satisfaction after the surgery.

Eligibility criteria:
inclusion criteria: * able to provide an informed consent. * age ≥ 18 years * biological males identified with male sexual organs. * scheduled for convective radiofrequency water vapor thermal therapy (rezum) for the management of benign prostate hyperplasia. exclusion criteria: * concomitant use of nephrotoxic and/or hepatoxic agents. * use of ≥ 6 ml penthrox withing the previous 3 weeks. * known allergies and/or adverse events due to penthrox, other halogenated anesthetics, percocet (oxycodone + acetaminophen), lorazepam, lidocaine, midazolam, ketamine, remifentanil and propofol * history of genetic susceptibility to malignant hyperthermia. * presence of clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment * altered level of consciousness due to any cause.
cough sound recordings to understand covid-19-like symptom progression to understand covid-19-like symptom progression

Conditions: Covid19

Summary: decentralized clinical study designed to collect further cough sounds, self-reported symptoms, and medical treatment questionnaires from participants enrolled on the covid-cough study ("study 1"). the aim of this further data collection study ("study 2") is to: 1. develop an understanding of changes in cough sounds associated with covid-19 and how they alter during the disease; 2. develop an understanding of other causes of covid-19-like symptoms and their associated cough sound patterns; and 3. gain a broader understanding of the clinical outcomes of individuals who present for covid-19 testing.

this study is designed to be administered in a decentralized manner to collect self-reported covid-19 symptoms, cough sample recordings and descriptions of recent medical treatment to investigate the following: 1. whether patterns unique to covid-19 disease can be detected in cough sounds collected over time; 2. the incidence of covid-19 and other lung diseases within individuals who test negative for covid-19; 3. whether existing machine learning algorithms can detect the presence of disease in the lower respiratory tract in participants; and 4. whether distinct cough sound patterns in covid-19 disease are associated with the requirement of medical treatment for covid-19 disease. through the administration of study 1, a list of potential participants will be created for whom the result of a recent rt-qpcr covid-19 test is known. participants have been consented to allow for outreach regarding further studies. cough samples and answers to medical questions have been collected from these individuals at the time of testing, and the aim of study 2 is to gather further cough samples and questionnaire answers over a period of 25 days.

Eligibility criteria:
inclusion criteria: * be aged 21 years and older; * be a resident of the usa; * have a personal (i.e., not shared) iphone 6s or newer running ios 14 or later; * be able to read and understand english; * be able to provide informed consent; * be willing to follow study procedures; * be able to provide at least 5 coughs (voluntary and/or spontaneous); * have enrolled in the covid-cough study and successfully returned an at-home rt-qpcr test to the study partner laboratory exclusion criteria: participant has one or more medical contraindication to voluntary cough, including the following: * severe respiratory distress; * history of pneumothorax; * eye, chest, or abdominal surgery within 3 months of enrolling for the study; or * hemoptysis (coughing up of blood) within 1 month of enrolling for the study;
diaphragm dysfunction in ards patients with v-v ecmo

Conditions: Respiratory Distress Syndrome

Summary: use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ards). given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. the present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with vv-ecmo.

use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ards). it allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. the objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. this strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest. given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.

Eligibility criteria:
inclusion criteria: * age \> 18 years * ards according to the berlin definition * v-v ecmo * patient or next of kin agrees to participate * patient with health insurance exclusion criteria: * pregnancy * opposition to participate * contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"

Keywords: ards ecmo diaphragm function
evaluate the safety, efficacy and pharmacokinetics of thiscart19a in patients with mrd+ b-all

Conditions: B-ALL

Summary: this is an open label, phase i study to assess the safety, efficacy and pharmacokinetics of thiscart19a in patients with mrd+ b-all


Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. all subjects or legal representatives must sign a voluntary letter of consent approved by the irb in person prior to the commencement of any screening procedure; 2. patients diagnosed with b-all according to the chinese guidelines for the diagnosis and treatment of adult acute lymphoblastic leukemia (2021 edition); 3. there is no gender limitation, age 18-65 (upper limit not included); 4. disease status ≥cr2 with bone marrow flow cytometry mrd≥0.1%. 5. patients with ph+ r/r all who failed after 2-line tki treatment, were intolerant to tki treatment or were not suitable for tki treatment; 6. the expected survival time is ≥12 weeks; 7. ecog score 0-1; 8. had good organic function during screening 9. cd19 was still expressed on leukemia cells in bone marrow, peripheral blood or biopsy tissue by flow cytometry, results within one month prior to informed consent are acceptable (after the last treatment). exclusion criteria: 1. allergic to preconditioning measures. 2. patients with other malignancies other than b-cell malignancies within 5 years prior to screening. patients with cured skin squamous carcinoma,basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited. 3. uncontrollable bacterial, fungal and viral infection during screening. 4. patients had pulmonary embolism within 3 months prior to enrollment. 5. had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment. 6. imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening. 7. \< 100 days after hematopoietic stem cell transplantation. 8. active hbv or hcv or hiv or syphilis infection. hbv-dna \< 2000 iu/ml can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenufovir, etc, and supervisory the relative indication during the treatment. 9. combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. or systemic diseases that require long-term use of immunization inhibitor. 10. vaccinated with influenza vaccine within 2 weeks prior to cleansing (sars-cov19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) . 11. patients who are receiving gvhd treatment; patients without gvhd and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion. 12. women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. male subjects who plan pregnancy within 1 year after infusion. 13. any ineligibility conditions considered by the investigator that may increase the risk of the subject or interfere with the results of the study.
abdominal exploration without incisions

Conditions: Pancreatic Cancer

Summary: this study is being conducted to determine whether an endoscope, (a small, flexible tube with a camera mounted on the end) passed down through the throat, through the stomach, and into the abdomen can safely and accurately examine the organs and tissue of the abdomen and take biopsies if needed. we wish to determine if this endoscopic diagnostic route is as efficient as the laparoscopic diagnostic route, which is currently the standard of care.

we propose to investigate the efficacy of transgastric endoscopic peritoneoscopy with endoscopic biopsy in patients undergoing diagnostic laparoscopy and who will require a concurrent gastrotomy for placement of a peg, gastrojejunostomy or gastric resection. we hypothesize that diagnostic endoscopic peritoneoscopy can be done safely with adequate visualization of the abdominal cavity to direct clinical treatment.

Eligibility criteria:
inclusion criteria: * pancreatic cancer undergoing staging laparoscopy * staging or diagnostic laparoscopy in anyone needing enteral access exclusion criteria: * lack of consent * intra-abdominal adhesions precluding diagnostic laparoscopy

Keywords: transgastric endoluminal peritoneoscopy diagnostic feasibility
evaluation of quality of vision and spectacle independence with the acrysof® panoptix® intraocular lens

Conditions: Cataract

Summary: this is a study to assess the spectacle independence and quality of vision of patients receiving the acrysof® panoptix® intraocular lens (iol) after uneventful cataract surgery.

this study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility criteria:
inclusion criteria subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal iol or multifocal toric iol option * gender: males and females. * age: 40 or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * have regular corneal astigmatism with a magnitude that can be treated with a non-toric iol or a toric iol in the approved ranged for the panoptix lens. * have 20/32 (0.2 logmar) or better potential acuity in both eyes exclusion criteria if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * irregular astigmatism (e.g. keratoconus) * corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye) * monocular status (e.g. amblyopia) * previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty) * previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * diabetic retinopathy * macular pathology (e.g. age-related macular degeneration, epiretinal membrane) * history of retinal detachment * subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating). the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: panoptix, trifocal iol, multifocal iol
evaluation of safety and efficacy of nvisionvle® imaging low profile system in patients with bile duct disease

Conditions: Bile Duct Diseases

Summary: a previous study evaluating the nvisionvle® imaging low profile system revealed the system to be feasible and safe for use in bile duct. the study also revealed a potential to better define abnormalities, target sampling and therapy when utilizing the nvisionvle® imaging low profile system. this study will further evaluate the safety and efficacy of the nvisionvle® imaging low profile system in patients with bile duct diseases.

the primary objective of this retrospective and prospective study is to acquire additional data to further evaluate the safety and efficacy of the nvisionvle® imaging low profile system in patients with bile duct disease. the secondary objective will be to provide a tool for participating physicians to collect imaging data, clinical utility data, and other clinical data such as demographics, pathology, and treatment surveillance results for patients who have undergone an examination of the bile duct with the nvisionvle® imaging low profile system. specific aims include completing a multi-center registry to further evaluate the safety and efficacy of the nvisionvle® imaging system low profile system and developing a tool from the nvisionvle® imaging low profile system data to better define abnormalities, target sampling and therapy in patients with bile duct disease.

Eligibility criteria:
inclusion criteria: * age 18 years or older * undergone ercp with nvisionvle® imaging low profile system at mdmc between 10/15/2017 and 10/15/2019. exclusion criteria: * below 18 years of age * did not undergo ercp with nvisionvle® imaging low profile system at mdmc
computer-based neurocognitive assessment in children with central nervous system tumors receiving proton beam radiation therapy

Conditions: Central Nervous System

Summary: this study will explore neurocognitive performance in pediatric brain tumor patients receiving proton beam radiation therapy (pbrt). the investigators goal is to gather baseline neurocognitive testing prior to the completion of the first week of radiation therapy along with follow-up testing 6-12 months after the completion of radiation and serial annual testing thereafter. with these data the investigators plan to evaluate the effects of pbrt on neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and radiation dose. modeling studies have demonstrated that pbrt could improve neurocognitive outcomes, but there is a paucity of prospectively-collected patient data. the investigators are uniquely positioned to address this important question given the busy pediatric central nervous system (cns) tumor service, the delivery of proton therapy at the s. lee kling proton therapy center at barnes-jewish hospital, and the multi-disciplinary research team with extensive experience into the late effects of therapy as it relates to neurocognition.


Eligibility criteria:
inclusion criteria: * diagnosis of primary cns tumor or diagnosis of metastatic disease to the cns with an expected overall survival of \> 1 year. any prior treatment (chemo, xrt, or surgery) is allowed. * planning to receive pbrt to treat the cns tumor. patients who have already received pbrt for this disease may also be enrolled provided they completed the nih toolbox cognitive battery prior to the first week of radiation therapy. * between 4 and 21 years of age (inclusive). * life expectancy of at least one year. * absence of visual impairment that would impede computer testing. * no secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer). * able to understand and willing to sign irb-approved written informed consent document (or signature of legally authorized representative).