Kornimate/medical-research-clean huggingface dataset:
a safety, tolerability, and efficacy study of ibi314 in ambulatory patients with covid-19

Conditions: COVID-19

Summary: this is a dose-finding, inferentially seamless phase 1/2 study evaluating the safety, tolerability and efficacy of ibi314 in ambulatory patients with covid-19.

phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 32 ambulatory adult patients with covid-19. this phase of the study is designed to assess the safety, tolerability, pk, and pd of ibi314 administered as a single iv infusion. phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 208 ambulatory adult patients with covid-19. this phase of the study is designed to assess the efficacy and safety of ibi314, administered by single iv infusion at dose levels that meet none of the termination criteria for dose escalation in phase 1 of the study.

Eligibility criteria:
main inclusion criteria: 1. first onset of covid-19 symptoms \<7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea. 2. have a positive sars-cov-2 reverse transcription-polymerase chain reaction (rt-pcr) test using an appropriate sample such as nasopharyngeal (np), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. a historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable. 3. male or female patients ≥18 years of age at the time of signing informed consent. 4. agree to use an adequate method of contraception throughout the study period and for 90 days after the dose of study drug is administered. 5. women of childbearing potential (wocbp) must have a negative urinary pregnancy test at screening. main exclusion criteria: 1. according to protocol v3.0, note: patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled. 2. have oxygen saturation (spo2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (pao2 in millimeters of mercury) to fractional inspired oxygen (fio2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute. 3. have evidence of multi-organ dysfunction/failure. 4. systolic blood pressure \<90 mmhg, diastolic blood pressure \<60 mmhg, or requiring vasopressors. 5. require or anticipated impending need for endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo).
buccal cancer resection ultrasound guided

Conditions: Buccal Mucosa Cancer; Squamous Cell Carcinoma

Summary: the aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

buccal mucosa cancer is a rare disease. in the netherlands, approximately 100 patients are treated for this disease each year. to obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). if the tumor-free margin is smaller, such as close (1-5 mm) or involved (\<1 mm) margins, there is usually an indication for adjuvant therapy. now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. during a re-resection it is often difficult to find the location of the insufficient margin. ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt. the aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life. in this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection. 50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. the tumor has to be visible as an hypo-echogenic region on the ultrasound.

Eligibility criteria:
inclusion criteria: * buccal mucosal squamous cell carcinoma * surgical removal under general anesthesia exclusion criteria: * tumor is not visible on ultrasound as echolucent region

Keywords: buccal mucosal carcinoma squamous cell carcinoma ultrasound multicenter
comparisons of two types of robot assisted gait training

Conditions: Stroke; Robot Assisted Gait Training

Summary: comparisons of two types of robot assisted gait training: exoskeleton type robot vs. end-effector type robot: randomized controlled trial


Eligibility criteria:
inclusion criteria: * hemiplegic patients secondary to first cerebrovascular accidents * ankle dorsiflexor strength: medical research council scale 2 or 3 * functional ambulation category score 3 exclusion criteria: * history of surgery of affected lower limb * fracture of affected lower limb
plegridy satisfaction study in participants

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Summary: the primary objective of this study is to investigate whether peg-ifn beta-1a improves the satisfaction of relapsing-remitting multiple sclerosis (rrms) participants unsatisfied with injectable subcutaneous interferons, as measured by the abbreviated treatment satisfaction questionnaire to medication (tsqm-9), at 12 weeks. the secondary objectives of this study are to evaluate in this study population: effects of peg-ifn beta-1a treatment on participants' satisfaction at 24 weeks; effects of peg-ifn beta-1a treatment on short-term participants' adherence; effects of peg-ifn beta-1a treatment on participants' fatigue; effects of peg-ifn beta-1a on disease activity and physical disability; impact of peg-ifn beta-1a treatment on participant-reported health-related quality of life; impact of peg-ifn beta-1a treatment on participants' injection-system satisfaction; evaluate the relationship between participants' satisfaction and adherence; evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate \[arr\], disability, etc.) and to evaluate the treatment safety and tolerability.


Eligibility criteria:
key inclusion criteria: * subjects diagnosed with relapsing remitting ms according to 2010 mcdonald criteria. * subjects with edss score between 0.0 and 5.0 at baseline. key exclusion criteria: * pregnancy or breast-feeding. * have any contra-indications to treatment with peg-ifn-beta 1a according to the summary of product characteristics. note: other protocol defined inclusion/exclusion criteria may apply.
safety and feasibility of an endotoxemia model

Conditions: Cardiovascular Disease; Inflammation

Summary: the purpose of this study is to establish the safety and feasibility of low dose lps administration to a small subset of humans in preparation for a larger usda funded study examining what is the lowest effective dose of epa + dha (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response the investigators wish to examine the effects of an endotoxemia model for inducing inflammation. based on previous research, low dose lps administration affects metabolism in humans with only minimal clinical effects (such as "flu" like illness). therefore, each of the six subjects included in this small pilot study will receive a low dose of lps and placebo in order to learn more about the metabolic changes that occur during administration and inflammation. the investigators hypothesis that lps administration will elicit only minimal clinical effects (such as "flu" like illness) when compared to placebo (saline--water with the same amount of salt as in your blood).


Eligibility criteria:
inclusion criteria: * healthy men and non-pregnant/lactating women between the ages of 20 and 35 years old * bmi \> 19.9 and \< 30.0 * able to give written informed consent and willing to comply with all study- related procedures exclusion criteria: * previous history of heart disease or diabetes * renal insufficiency * chronic anti-inflammatory use * systolic blood pressure \< 90 * individuals currently using tobacco products or have done so in the previous 30 days * individuals taking omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month

Keywords: cardiovascular disease inflammation lps endotoxin
comparison of the performance of the infiniti vision and the series 20000 legacy phacoemulsification systems

Conditions: Cataract Extraction

Summary: to compare the efficiency of the infiniti vision system and the series 20000 legacy system phacoemulsification units during routine cataract extraction.


Eligibility criteria:
inclusion criteria: * cataract * eligible for cataract extraction with primary implantation of a posterior chamber iol * 2 to 3+ cataract density exclusion criteria: * preoperative ocular pathology that can affect visual acuity * corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities. * previous intraocular or corneal surgery. * other ocular surgery at the time of the cataract extraction. * surgical exclusion criteria: * significant intraoperative intraocular bleeding * detached descemet's membrane * implantation of the intraocular lens in the anterior chamber or sulcus
a stylet use may be beneficial for elective and rescue intubation of prematurely born infants

Conditions: Neonatology

Summary: contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. the goal is to compare the safety and efficiency of intubations with or without a stylet.

recent studies have found that using a stylet does not offer any benefits during intubation across a diverse infant population. the research, however, specifically targets extremely and very premature infants undergoing elective or rescue intubation in the delivery room. a single-center retrospective observational study was conducted to compare the number of intubation attempts, the duration of intubation until successful, and the rate of associated desaturations exceeding 20%. the outcomes were determined through video recordings and statistical analysis.

Eligibility criteria:
inclusion criteria: * intubation in the delivery room exclusion criteria: * both method used, video record not available

Keywords: resuscitation extremely premature infant intubation stylet
study using folatescan to identify subjects with folate receptor-positive metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with folate receptor-positive metastatic renal cell carcinoma

the investigational new drug (folatescan or technetium tc 99m ec20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. the folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. in contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. therefore, these folate conjugates are specific to cancer cells. this is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of folatescan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of folatescan compared to immunohistochemical staining (ihc).

Eligibility criteria:
inclusion criteria: * to be eligible for the study, patients must fulfill all of the following criteria: 1. patient must be 18 years of age or older. 2. patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion \>2.0 cm as diagnosed by ct, mri, or ultrasonography within 60 days prior to enrollment. 3. patient must have good kidney function defined as a serum creatinine ≤1.5 x uln. 4. patient must provide written informed consent prior to enrollment. 5. patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for ihc staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of folatescan. a fine needle aspirate is not acceptable. exclusion criteria: * any of the following criteria will make the patient ineligible to participate in this study: 1. patient is pregnant or breastfeeding. 2. patient is simultaneously participating in another investigational drug study, excluding the follow-up phase. 3. patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment. 4. patient is unable to tolerate conditions for radionuclide imaging. 5. patient has been administered another radiopharmaceutical that would interfere with the assessment of technetium tc 99m ec20.

Keywords: renal cell
obwell: innovative psychotherapeutic intervention to treat postpartum depression

Conditions: Post Partum Depression

Summary: postpartum depression (ppd) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". ppd differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. the symptoms of ppd interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby \[1\]. one-third of women in the u.s. with ppd are identified in clinical settings, yet only half of those begin psychotherapy treatment \[2\]. unfortunately, mothers whose newborns are in the neonatal intensive care unit (nicu) are at high risk for developing ppd \[3,4\], necessitating early identification and evidence-based treatment. cognitive behavioral therapy (cbt) and interpersonal therapy (ipt) are the two most effective psychotherapy treatments for ppd \[5,6\], yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for ppd than either approach alone. this clinical trial aims to compare the effectiveness of a 4-week intervention of either cbt or ipt for ppd in nicu mothers and to determine whether a sequential 8-week intervention (ipt then cbt, or cbt then ipt) is more beneficial.


Eligibility criteria:
inclusion criteria: * mother of nicu infant * older than age 18 * english-speaking * gave birth more than 24 hours ago and less than 12 months prior to enrollment * depression as assessed by: current/prior diagnosis of major depressive disorder or epds score above 10 or epds score below 10 and endorsement of "sometimes" or "often" on item #10 on the epds\* ("i have had thoughts of harming myself") exclusion criteria: * a diagnosis of substance dependency or substance use * acute suicidal or infanticidal ideation * current psychosis * medical history of cognitive impairment * infant death of current nicu admission * marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments), * are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)

Keywords: post partum depression cognitive behavioral therapy interpersonal therapy psychotherapy nicu
the ap-gelp study: a clinical trial on the effects of apremilast in female genital erosive lichen planus

Conditions: Lichen Planus of Vulva; Female Genital Disease

Summary: genital erosive lichen planus (gelp) is a chronic inflammatory disease causing painful genital sores and scarring in women. treatment options are limited and often unsatisfactory. this trial will study the effects of treatment with apremilast and quality of life and sexual function in women with gelp.

genital erosive lichen planus (gelp) is a chronic, inflammatory and scarring genital disease. the disease may have a significant impact on daily living, quality of life and sexual function. there is a considerable lack of high-quality evidence on treatment options for gelp and few effective therapeutic facilities available in current clinical practice. the aims of this study are to investigate clinical and immunohistochemical effects of a new oral anti-inflammatory treatment, apremilast, for women with moderate-to-severe gelp in a double-blinded, randomized, placebo-controlled trial (rct). apremilast is an inhibitor of phosphodiesterase 4 (pde4) with documented effect in several inflammatory skin diseases, but it has not yet been studied in patients with gelp. the drug dose and study design have been chosen based on relevant experience from other studies on apremilast, and is equivalent to the dose used for approved indications (chronic plaque psoriasis and psoriatic arthritis). the main objective of this trial is to assess the efficacy of apremilast in the treatment of gelp in women. secondary objectives include * description of immunohistochemical changes in lichen planus lesions * assessment of safety of apremilast in the treatment of gelp * assessment of quality of life and sexual function

Eligibility criteria:
inclusion criteria: * moderate to severe gelp at inclusion with the diagnosis based on characteristic clinical and/or histological features. minimum gelp score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain ≥1 are mandatory * informed consent from the patient to the protocol and clinical procedures. exclusion criteria: * patients receiving other systemic immune modulating therapy * concomitant use of strong cyp3a4 enzyme inducers * inadequate birth control, pregnancy and/or breast-feeding * depression and suicidal ideation * patients with severe renal impairment * patients with active tuberculosis, serious infections or cancer * unexplained and clinically significant weight loss in underweight patients * hypersensitivity to the active substance(s) or to any of the excipients * hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption * participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial

Keywords: apremilast genital erosive lichen planus
the eu hyprotect registry

Conditions: Hemodynamic Monitoring

Summary: european, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery


Eligibility criteria:
inclusion criteria: * consenting adult patients (≥18 years) * patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter * patients in whom the acumentm hypotension prediction index software with the acumen iq sensor on the hemosphere platform is used intraoperatively exclusion criteria: * patients undergoing emergency surgery or nephrectomy, liver and/or kidney transplantation * patients suffering from atrial fibrillation and/or sepsis (according to current sepsis-3 definition) * american society of anesthesiology (asa) physical status classification v or vi * disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation * pregnancy at the time of surgery * patients without signed informed consent / data protection statement * patient participating in other interventional trials

Keywords: intraoperative hypotension, preventive therapy, blood pressure monitoring
open randomized prospective clinical study of r-fpd versus r-mad regimen in the treatment of primary central nervous system lymphoma

Conditions: Primary Central Nervous System Lymphoma

Summary: comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma

this is an open, randomized, prospective, multicenter clinical study designed to compare the efficacy and safety of r-fpd and r-mad as first-line regimens in the treatment of primary central nervous system lymphoma. a total of 20 patients plan to participate in the study. the primary endpoints were objective response rate (orr) and progression-free survival (pfs) and secondary endpoints including overall survival (os), and adverse events.

Eligibility criteria:
inclusion criteria: age 14-75 years old; kps score ≥ 60 points or ecog score ≤ 2 points; expected survival period of more than 3 months; cd20 positive; pcnsl confirmed by tissue biopsy pathology (limited to brain, spinal cord, meninges and eyes, without lymphoma involving other parts of the body); no chemotherapy contraindications (blood and physiological examination results \<7 days); at least one measurable lesion according to the recist criteria; there are no other serious diseases that conflict with this plan; there is a possibility of follow-up; when using other anti-tumor drugs at different times during this treatment, bisphosphonate anti-bone transfer therapy and other symptomatic treatments may be applied; can understand the situation of this study and sign the informed consent form. \*: pathological histology is subject to consultation by pathologists at provincial hospitals. exclusion criteria: currently receiving other chemotherapy, radiotherapy and targeted therapy (chemotherapy within 3 weeks, radiotherapy within 2 weeks, or recovery from acute toxicity of any previous treatment); pregnant or lactating women; there are any uncontrollable medical diseases (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia); combined with chemotherapy and other contraindications for chemotherapy; those who have had other malignant tumors in the past; there are uncontrolled infected patients; those who have a history of mental illness that is difficult to control; the investigator believes that it is not appropriate to participate in this test.

Keywords: rituximab fotemustine pemetrexed orr os pfs