Kornimate/medical-research-clean huggingface dataset:
a trial of shr-1210 (an anti-pd-1 inhibitor) in combination with apatinib and fluzoparib in patients with tnbc

Conditions: Triple Negative Breast Cancer

Summary: the study is being conducted to evaluate the tolerability, safety and efficacy of shr-1210 in combination with apatinib and fluzoparib in subjects with recurrent and metastatic triple negative breast cancer

drug: shr-1210 + apatinib +fluzoparib shr-1210 will be administered as an intravenous infusion, apatinib tablets will be given orally, fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity. treatment group ： pd-1 antibody shr-1210 combination with apatinib and fluzoparib

Eligibility criteria:
inclusion criteria: * signed the informed consent. * female aged ≥18 years old. * histologically diagnosed patients with recurrent and metastatic triple negative breast cancer. * no more than 2-line chemotherapy failed at the stage of recurrence and metastasis . * patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment * at least one measuring lesion that confirmed by recist v1.1 standard. * the patients can swallow pills. * have a life expectancy of at least 12 weeks. * the functions of vital organs meet protocal requirements. exclusion criteria: * subjects had any history of active autoimmune disease . * subjects had previously been treated with anti-pd-1 and pd-l1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with parp inhibitors. * subjects have untreated central nervous system metastasis. * history of hypertension and antihypertensive medications are not well controlled. * some clinical symptoms or diseases of the heart that are not well controlled. * history of immunodeficiency including hiv-positive. * subjects had active infections.
the diagnostic pattern and prognosis of multiple myeloma patients with myocardial amyloidosis were evaluated by nmr based metabolomics

Conditions: Multiple Myeloma; Amyloidosis Cardiac

Summary: in this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. an exploratory study was conducted to compare the effects of various sublayer factors (m protein, electrocardiogram, echocardiography, cd138, chromosome abnormalities, etc.) on patients' survival. on this basis, a hierarchical diagnostic model (1-2-3-4) for patients with multiple myeloma complicated with myocardial amyloidosis was established based on the phenoomics of nmr and mass spectrometry, and the prognosis was evaluated simultaneously, in order to create an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and lay a foundation for the early application of effective treatment.

the purpose of this study was to collect clinical data of patients with multiple myeloma complicated with myocardial amyloidosis, analyze and collate the data through statistical methods, and explore the clinical characteristics of patients with mm complicated with myocardial amyloidosis, the factors that may lead to the occurrence of myocardial amyloidosis and the differences in the data of cardiac ultrasound and other biochemical tests, so as to evaluate the prognosis of patients. to investigate the clinical features, risk factors and prognosis of patients with multiple myeloma myocardial amyloidosis. the clinical experience of diagnosis and treatment of this complication was summarized. on this basis, a standard database suitable for the northwest population was established based on nmr phenoomics, and a hierarchical diagnostic model (1-2-3-4) was explored for multiple myeloma patients with myocardial amyloidosis, and the prognosis was evaluated simultaneously. in order to establish an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and to provide clinical basis for further research on early diagnosis, early prevention and early treatment of the disease. to provide the basis for individualized stratified prevention and treatment of patients with multiple myeloma myocardial amyloidosis, reduce the family medical burden and related side effects, improve the quality of life of patients with myeloma myocardial amyloidosis, prolong the survival period, and improve the cure rate

Eligibility criteria:
inclusion criteria: a patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since january 1, 2018 exclusion criteria: a patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since january 1, 2018
ivig in patients with severe covid-19 requiring mechanical ventilation

Conditions: Covid19; SARS-CoV Infection

Summary: the purpose of this pilot study is to establish a hypothesis of whether or not intravenous immunoglobulin (ivig) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with sars-cov-2 virus.

this is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting ivig administration within 48 hours of mechanical ventilation. the exploratory objective is to analyze the blood before, during and after ivig administration. the blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via mass spectrometry.

Eligibility criteria:
inclusion criteria: 1. confirmed covid-19 positive test result 2. initiation of the first dose of ivig within 72 hours of mechanical ventilation. 3. age \>18 years old. 4. consenting next of kin having access to an electronic device that is able to access docusign® online and email for consenting. 5. subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. exclusion criteria: 1. superimposed bacterial pneumonia or bacteremia 2. severe allergy to any ivig product formulation 3. hypersensitivity to corn 4. uncontrolled hypertension (sbp\>180 mm hg or dbp\>120mmhg) 5. active participant in another research treatment study 6. advanced dementia 7. severe renal disease (crcl\< 20 ml/min) 8. active cancer malignancy 9. active treatment with cancer chemotherapy or immunotherapy 10. congestive heart failure clinically or by history (ef\< 25%) 11. prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab) 12. venous or arterial thrombosis \< 90 days prior 13. are receiving cytotoxic or biologic treatments such as tnf inhibitors, anti-interleukin-1 (il-1), anti-il-6 (tocilizumab or sarilumab), t-cell or b-cell targeted therapies (rituximab), interferon, or janus kinase (jak) inhibitors for any indication at study entry. note: a washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions: * b-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer) * tnf inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and * jak inhibitor: a washout period of 1 week or 5 half-lives (whichever is longer).
splinting after mini-open carpal tunnel release

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study is to determine if any difference exists among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (ctr) surgery.

we sought to determine if any significant difference in patient-reported or clinical outcomes existed among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (ctr) surgery for symptomatic, isolated, nerve conduction study positive carpal tunnel syndrome (cts). a total of 249 patients received a mini-open ctr and were subsequently randomized into 1 of the 3 splinting regimens to be removed at the first postoperative visit 10-14 days later. patient-reported outcomes included quickdash surveys, levine-katz symptom severity scale (sss) and functional status scale (fss) and pain at rest and in action using a numerical pain rating scale (nprs). clinical outcomes included wrist range of motion (rom), grip and lateral pinch strengths. all outcomes were evaluated bilaterally at 10-14 days, 6 weeks, 3 months, 6 months and 12 months after surgery. demographic information was obtained preoperatively and complications were observed for and recorded throughout the study

Eligibility criteria:
inclusion criteria: * patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive cts. exclusion criteria: * exclusion criteria omitted patients who presented with acute onset cts, concomitant peripheral neuropathy, metabolic disease, postoperative recurring cts, or who required another operative procedure during carpal tunnel release.

Keywords: postoperative dressing postoperative splint mini-open carpal tunnel release
remote methadone ingestion surveillance trial (rmist)

Conditions: Opioid Use Disorder

Summary: the remote methadone ingestion surveillance trial (rmist) will explore a potential method of methadone ingestion surveillance that may mitigate patient safety risks of take-home methadone treatment regimens while minimizing the risk of diversion and evaluating the acceptability and feasibility of these monitoring methods. the method utilizes an innovative existing technology.

the remote methadone ingestion surveillance trial (rmist) aims to evaluate the performance and acceptability of a remote methadone ingestion surveillance that may mitigate the patient safety risks of take-home methadone treatment regimens for opioid use disorder (oud) while minimizing the risk of diversion. data describing the monitoring performance and patient acceptability of the method will inform investigators of the feasibility of using remote surveillance technology to monitor medication for oud and mitigate treatment barriers. this study will lay the groundwork for a safe and robust remotely monitored methadone treatment platform that addresses long-standing accessibility and acceptability barriers to treatment for oud.

Eligibility criteria:
inclusion criteria: * be male or female, 18-65 years of age * currently receiving methadone maintenance treatment (mmt) for the treatment of opioid use disorder (oud) * currently receiving a take-home methadone regimen of no more than three days per week (with or without covid-19 exceptions) * possess an internet-connected computer or smartphone with a front facing camera. exclusion criteria: * drug overdose requiring hospitalization within the last 12 months * currently or soon to be in jail or prison; currently on probation; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities * pregnant women * serious psychiatric disorders that would interfere with study participation as determined by the study site medical clinician * any participant that, according to the study team, may find it difficult to adhere to study procedures (e.g., no internet access, etc.) or are unable to operate the web-based platform for remote methadone ingestion
in-office hysteroscopic laser ablation for symptomatic submucous uterine fibroids

Conditions: Laser Hysteroscopic Ablation of Submucous Myoma

Summary: to evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser

a pilot study was conducted between january 2018 and january 2019 in a tertiary care university hospital. patients with at least one symptomatic, class 0-2 of figo classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. evaluation of the changes in fibroid size and vascularity was performed using 3d doppler ultrasonography. vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.

Eligibility criteria:
inclusion criteria: * symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation), * grade 0-2 (figo classification) ≤ 7cm fibroids with evident vascularity seen by 3d-ds compared to its adjacent myometrial tissue exclusion criteria: * intramural fibroids (figo class 3 or more), * \>2 submucosal fibroids, * pelvic inflammatory disease, * known gynecologic malignancy, * severe cervical stenosis, * pregnancy * desire of future fertility, * previous cervical surgery
european sapheon™ closure system observational prospective (escope) study

Conditions: Venous Insufficiency of Leg

Summary: the primary objective for this clinical study is to assess the role of the ce marked sapheon closure system in closure of incompetent great saphenous veins "gsv" in a routine clinical setting.

this is a post market, observational study of closure of the great saphenous vein "gsv". efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the sapheon closure system are consistent with or better than the expectations of the medical community for alternative treatments, specifically laser thermal ablation and radiofrequency ablation. additional comparison points may include measurements of pain and/or length of time to return to work.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤ 70 years of age. * symptomatic primary great saphenous vein "gsv" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging. * ceap classification of c2, c3 or c4. * ability to walk unassisted. * ability to attend follow-up visits. * ability to understand the requirements of the study and to provide written informed consent. * "gsv" on standing pre-procedure doppler ultrasound ≥3mm and ≤10mm (maximum diameter). exclusion criteria: * life expectancy \< 1 year. * regular pain medication. * anticoagulation including heparin or coumadin. * previous deep vein thrombosis "dvt". * previous superficial thrombophlebitis in "gsv". * previous venous treatment on target limb. * known hyper-coagulable disorder. * conditions which prevent routine vein treatment like: * acute disease, * immobilization or inability to ambulate, and * pregnancy. * tortuous "gsv", which in the opinion of the investigator will limit catheter placement. (no 2 primary access sites allowed). * incompetent ipsilateral small saphenous or anterior accessory great saphenous vein. * known sensitivity to the cyanoacrylate "ca" adhesive. * current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
evaluation of the animal intervention used as therapy

Conditions: Alzheimer Disease

Summary: the animal-assisted therapy (aat) is now considered a non-drug care and is often used in geriatrics. many studies have shown a link between the presence of the animal and the psycho-behavioral symptoms decrease in dementia (pbsd) such as depression, anxiety or irritability that affects their quality of life and improved cognitive abilities. however, many methodological flaws in these researches exist. the aim of the study is to evaluate the effectiveness of aat on the well-being of patients with alzheimer disease (ad) at the stage of major neuro cognitive disorder (ncd) at short and medium term (before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session) compared to a group receiving the same stimulation without the dog's response. patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: aat group versus control group. the only difference between these two groups is the intervention of the dog at each workshop in the aat group. each workshop will consist of three identical times. it will begin with a 15 minute introductory activity, the first goal will be to establish a relationship with patients (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the session this study should highlight a positive effect of animal assisted therapy on the well-being, pbsd, depression, anxiety and cognitive abilities and a long-term retention of these positive effects.


Eligibility criteria:
inclusion criteria: enrolled patients should have been informed and should not oppose the research, by themselves or through a trusted person, failing this, by the family, or, by a close person maintain stable ties; subject aged over 65 years fulfilling the criteria of alzheimer's disease the major ncd stage with or without vascular disorders; ambulatory patient in charpennes day hospital ; being affiliated to health insurance. exclusion criteria: patients with signs and symptoms suggestive of dementia related to other diseases than ad or mixed forms ; patients with progressive and unstable pathologies which could interfere with the variables under consideration ; deafness or blindness which could compromise the evaluation of the patient or his involvement during the sessions ; patient being under guardianship ; patient refusing the work with a animal ; patient allergic to dogs ; patient ending his care prior to the 13 weeks required for the study. exclusion criteria will be sought during the questioning of the patient and his relatives as well as the review of his medical file (organic and neuroradiological explorations).

Keywords: animal assisted therapy well-being alzheimer's disease
behavioral economic incentives to improve glycemic control among adolescents and young adults

Conditions: Diabetes; Type 1 Diabetes

Summary: in this study the investigators will compare a novel approach using daily financial incentives and a tiered sponsor network to motivate adolescents and young adults with type 1 diabetes to improve glycemic control.

participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with ≥1 readings within goal range (70-180 mg/dl) and provided with ihealth wireless glucometers. half of the study participants will be randomized to the 3-month intervention arm on way to health. the intervention includes daily financial incentives ($60 in an account at beginning of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). the primary outcome will be hba1c at 3 months compared to baseline. secondary outcomes will include hba1c at 6 months and the proportion of participants adherent to daily glucose monitoring goals. exit interviews will elicit intervention feasibility and feedback from a youth perspective.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes * hba1c of 8 or greater * receiving care from the childrens hospital of philadelphia diabetes center * english-speaking * owns a smartphone exclusion criteria: * new diagnosis of type 1 diabetes within past year * unable to provide informed consent * already participating in another study to improve glycemic control * any medical conditions that would prevent completion of the study

Keywords: diabetes adolescent young adult behavioral economics financial incentives social incentives
analgesic effect of breastmilk for procedural pain in preterm infants

Conditions: Procedural Pain

Summary: hypothesis: breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. the objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (dan). the sample size is 21 preterm infants in each two groups. the main end point is a reduction of the risk to have a dan superior to 1 from 80% with oral sucrose to 40% with breastmilk.


Eligibility criteria:
inclusion criteria: * preterm neonates born before 27 and 29+6 weeks ga * blood sampling procedure * obtention of parental consent exclusion criteria: * congenital malformation * intravenous continuous analgesia * contraindications to feed * high grade intracerebral hemorrhage

Keywords: breastmilk oral sucrose analgesia preterm neonates neonates
low-intensity versus medium-intensity continuous kidney replacement therapy for critically ill patients

Conditions: Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Summary: this clinical trial aims to investigate whether the low treatment intensity (12 ml/kg/hr, low-dose hemodialysis/filtration) or the medium treatment intensity (25 ml/kg/hr, standard-dose hemodialysis/filtration) is more effective and safer for continuous renal replacement therapy in critically ill patients.


Eligibility criteria:
inclusion criteria: patient who meets all of the following criteria and who has given informed consent. 1. adults (18 years of age or older, regardless of the time since icu admission) currently admitted to an intensive care unit\*. \*includes high care units, where continuous monitoring is conducted and intensive care physicians are in charge of medical care. 2. a diagnosis of acute kidney injury is made according to the kidney disease: improving global outcomes (kdigo) international diagnostic criteria (one of the following is met) * serum creatinine increased by more than 0.3 mg/dl within 48 hours * serum creatinine increased more than 1.5-fold from baseline and the increase is considered to have occurred within 7 days * oliguria (\< 0.5 ml/kg/hr) lasting more than 6 hours 3. the treating intensivist believes that continuous kidney replacement therapy is necessary exclusion criteria: patient who meets any of the following exclusion criteria will be excluded. 1. receiving chronic dialysis or scheduled for initiation of chronic dialysis 2. undergoing any kidney replacement therapy or blood purification therapy within 48 hours 3. when kidney replacement therapy using other dialysate or replacement fluids, such as citrate dialysis, is preferred due to coexisting bleeding disorders or allergy to acetate 4. concomitant blood purification therapy other than hemofiltration/dialysis, such as plasma exchange 5. the patient is in a very critical condition and the treating physician believes that survival for more than 24 hours is unlikely 6. previous participation in the study 7. after receiving a full explanation of the study and with full understanding, a patient do not consent to participate in the study of their own (or their substitute decision maker's) will. 8. the principal investigator (or an investigator) thinks it to be inappropriate to participate in this study.