Kornimate/medical-research-clean huggingface dataset:
purify antigen-specific b cells from patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune disease characterized by the presence of autoantibodies directed against citrullinated proteins, called acpas. these antibodies are very specific to ra, and the severity of the disease is closely correlated with the level of these acpas, even though they appear much earlier than the clinical signs. current treatments by biotherapies are effective but only treat the inflammatory symptoms of the disease or, on the contrary, induce a global immunosuppression with a depletion of all b lymphocytes. contrary to the current approaches, the cure ra project proposes a double innovative character: * the project aims at specifically destroying b lymphocytes expressing / or secreting acpas for a more specific approach to ra, without inducing immunosuppression. * the new therapeutic molecule is entirely original and has no equivalent at present, it uses the target antigens of autoantibodies, the citrullinated peptides, as tools to destroy the pathogenic b cells that express/produce these autoantibodies.


Eligibility criteria:
inclusion criteria: - antibodies anti-ccp + (acpa +) \> 250 iu/ml exclusion criteria: * current or past rituximab (mabthera) treatment past (\< 9 months) * abatacept treatment

Keywords: b cells rheumatoid arthritis acpa
pancreatic cancer biomarker study

Conditions: Pancreatic Adenocarcinoma

Summary: this is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

this is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer. study participants will be recruited by physician referral or from a list of clinical patients being evaluated for a potential pancreatic abnormality or for potential treatment of pancreatic cancer. additionally, a surveillance cohort will be recruited among individuals who are being monitored for recurrence following surgical or medical treatment for pancreatic cancer. peripheral blood specimens will be collected from all participants at time of enrollment. additional specimens may be collected from surveillance cohort participants no more frequently than once every 3 months as clinically indicated. the specimens will be sent to a clinical lab for stra biomarker and ca19-9 analysis. participants will be followed for 36 months to track clinical outcomes. the performance of the investigation biomarker for the diagnosis, prognosis, or surveillance of pancreatic cancer will be compared to the performance of ca19-9.

Eligibility criteria:
inclusion criteria: diagnosis/prognosis cohort * patients being evaluated for possible pancreatic abnormality, via additional radiological test (endoscopic ultrasound, abdominal ct scan), blood test (ca19-9), or other diagnostic procedure. * patients being evaluated for medical or surgical treatment for pancreatic cancer or pancreatitis on the basis of previous clinical and radiological findings. surveillance cohort * patients being monitored or who will be monitored for potential recurrence of pancreatic cancer following surgical or medical treatment of pancreatic adenocarcinoma. exclusion criteria: * the participant is unwilling or unable to provide written informed consent. * in the investigator's opinion, the participant is unsuitable for the study. * the participant does not speak english. * the participant is a prisoner. * the participant is known to be pregnant. * the participant is less than 18 years of age.
nitrous oxide for acute migraine pain in the emergency room (ed)

Conditions: Migraine; Pain

Summary: background migraine headaches account for 8-18% of all headaches seen in pediatric emergency rooms. standard treatment includes iv pain medications, anti-emetics, and iv fluids. nitrous oxide has analgesic properties similar to those of opioids and is easy to administer. it has been shown in two small studies to be effective in treating migraine headaches. research question does nitrous oxide act as a safe, less invasive, and effective treatment of acute migraine headaches in children and adolescents presenting to an emergency department? design this is a prospective non-randomized self-controlled study. repeated measures will be taken to examine change in pain scores before and after nitrous oxide treatment. methods each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment at multiple time-points.


Eligibility criteria:
inclusion criteria: * during the study enrollment period, eligible subjects will be english-speaking children and adolescents * between the ages of 8 - 18 years (inclusive) * with history of migraine present for at least one year * with previous migraine headaches conforming to ichd-ii diagnostic criteria * able to give assent according to institutional guidelines, and * have parental consent to participate. exclusion criteria: * any patients will be excluded if he/she * has had any neurosurgical interventions * has underlying seizure disorders * presents with a headache of a different quality than their other migraines * has contraindications to nitrous oxide * unable to complete the pain assessment * does not have a dependable contact number for the follow-up call

Keywords: migraine pediatric adolescent nitrous oxide
a study of the effect of lenalidamide on complex regional pain syndrome type 1

Conditions: Complex Regional Pain Syndrome, Type 1

Summary: the purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (crps).


Eligibility criteria:
inclusion criteria: 1. age \> or = to 18 years 2. signed consent form 3. a diagnosis of crps type i for at least one-year duration with unilateral involvement of a distal limb 4. crps pain intensity score at least 4 on an 11-point pi-nrs 5. measurable sural, median sensory, median motor and peroneal motor nerve conductions 6. women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. they must agree to use adequate contraceptive methods not including steroid-based contraceptives. they must also agree to have pregnancy tests every 4 weeks while on the study drug.
rhomboid flap vs. deep suturing in recurrent pilonidal sinus

Conditions: Pilonidal Sinus Infected

Summary: this prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.

pilonidal disease derives its name from latin- pilus meaning "hair," and nidus meaning "nest" . the source of pilonidal disease is thought to be a deep intergluteal sulcus. it is widely accepted that the establishment of the pilonidal sinus results from the penetration of shed hair shafts through the skin, which ultimately leads to an acute or chronic infected site . pilonidal disease is largely considered a surgical disease, especially in acute instances with secondary infection and abscess. infection or abscess requires incision and drainage. definitive treatment is delayed the majority of the time if there is an acute infection or abscess until after the infection has been addressed. surgical options for chronic disease are numerous and can include "pit picking," curettage, aspiration, unroofing, or surgical excision. defects can be closed primarily, with flaps or grafts, or allowed to heal by secondary intention . the most serious problem of the various surgical approaches proposed is the recurrence rate, ranging from 0% to 40% . the surgical treatment of patients with recurrent disease does not differ from the surgical treatment of primary pilonidal disease. in case of a recurrence with an abscess, incision and drainage prevail, while in case of chronic recurrent disease, a flap based procedure may be indicated following sinus excision with scarring, like the rhomboid flap .

Eligibility criteria:
inclusion criteria: * adult patients aged between 18 and 60 years; * patients with one or two small inactive sinuses will be included for easier excisional procedures; * previous intervention for pilonidal disease whether surgical or non-surgical; exclusion criteria: 1 - patients with an acute abscess. 2- patients with mall inactive pilonidal sinus disease. 3- age beyond the previous limits. 4- patients with primary pilonidal disease. 5- refusal to participate in the study. 6- unfit for anaesthesia and surgery. 7- patients with malignant neoplasms or inflammatory bowel disease.

Keywords: rhomboid flap deep suturing
an2728 topical ointment to treat mild-to-moderate plaque-type psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine whether an2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (bsa) excluding face, scalp, and genitals * willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits * women of childbearing potential must agree to use contraception for the entire study period exclusion criteria: * any dermatological conditions that could interfere with clinical evaluations * concurrent or recent use of certain topical or systemic medications without a sufficient washout period * significant confounding conditions as assessed by study doctor * participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study * use of lithium- or hydroxychloroquine-containing products (e.g., plaquenil) * use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months * pregnancy or lactation

Keywords: psoriasis
manual versus ai-assisted clinical trial screening using large-language models

Conditions: Comparing Manual and AI Patient Screening in Heart Failure

Summary: a prospective randomized controlled trial comparing manual review and ai screening for patient eligibility determination and enrollments. a structured query will identify potentially eligible patients from the mass general brigham electronic data warehouse (edw), who will then be randomized into either the manual review arm or the ai-assisted review arm.

screening participants for clinical trials is a critical yet challenging process that requires significant time and resources. traditionally, patient screening has been manual, relying on the diligence and judgment of study staff. however, manual screening is prone to human error and inefficiencies, contributing to high costs and prolonged trial durations. recent advancements in natural language processing (nlp) and large language models (llms), such as gpt-4, offer potential solutions to improve the accuracy, efficiency, and reliability of the screening process. retrieval-augmented generation (rag)-enabled systems, like rectifier, have shown promise in enhancing clinical trial screening by automating the extraction and analysis of relevant data from electronic health records (ehrs). in the investigators' previous study, rectifier demonstrated high accuracy in screening patients for clinical trials, aligning closely with expert clinician reviews and outperforming manual study staff in several criteria. it underscored the potential for llms to transform clinical trial screening, making it more efficient and cost-effective while maintaining high standards of accuracy and reliability. however, before rectifier is scaled to be used across many domains of clinical trials, it should be validated prospectively in the real-world setting to enroll patients. in the co-operative program for implementation of optimal therapy in heart failure (copilot-hf) trial (nct05734690), the investigators will identify potential participants through ehr queries followed by manual review, which provides an opportunity for rectifier to improve the screening process. by leveraging rectifier, this study aims to evaluate the effectiveness of automated ai screening compared to traditional manual methods for enrollments of patients into an ongoing clinical trial.

Eligibility criteria:
inclusion criteria: * documented diagnosis of heart failure (e.g., icd-9 codes 428 icd-10 codes i50 or problem list in the electronic health record) * most recent left ventricular ejection fraction (lvef) assessed within the past 24 months * seen mass general brigham provider within the last 24 months exclusion criteria: * lvef \<50% currently prescribed or intolerant to an evidence-based beta-blocker, arni, mra, and sglt2i at least 50% goal dose * lvef\>50% currently prescribed or intolerant to sglt2i * systolic blood pressure (sbp) \<90 mmhg at last measure
transdiagnostic oncology program in primary care

Conditions: Cancer Survivor

Summary: the goal of this observational study is to learn about how cancer survivors experience a relatively new 12-month interdisciplinary aftercare program called the transdiagnostic oncologic program (top). top is an innovative program offered as part of routine family-doctor care among several practices in the province drenthe, the netherlands. it is coordinated by the family doctor and caried out by an interdisciplinary team, consisting of the family doctor, a physiotherapist, nutritionist, and optionally a psychologist. the main questions this study aims to answer are: * is top feasible and acceptable? * does top lead to improvements in quality of life in cancer survivors? patients who were eligible for the program (n=54) were asked to participate in research as well. everyone who participated in top (n=19) agreed to participate in this study as well. those who declined participation (n=35), were asked to serve as controls, of which 16 agreed to do so.


Eligibility criteria:
eligibility criteria for the program and for the study were the same, with the exception that participants were willing to sign informed consent to participate in the study. inclusion criteria: * being between ≥18 and ≤ 75 years old * having been diagnosed with cancer at least 6 months ago and/or have been long-term stable. exclusion criteria: * having severe physical risks due to cancer treatment and / or comorbidities * currently undergoing intensive chemotherapy or other treatment * having cognitive or psychosomatic complaints that interfere with successful participation * having skin cancer, except for melanomas with metastasis * having a life expectancy of \<1 year

Keywords: cancer survivor family-doctor led aftercare program lifestyle intervention transdiagnostic general practitioner interdisciplinary
development of an early warning score for detecting the deterioration of a patients' general condition in an acute hospital

Conditions: General Condition

Summary: an acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters. an early warning system (ews) shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. its predictive power and accuracy shall be investigated. in a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous ews on wearables will be examined.

an acute deterioration of a patients' general condition is often preceded by changes in individual vital parameters and may lead to adverse events, such as admission to the intensive care unit, heart attack or death. some of them are potentially avoidable if appropriate measures are taken in a timely manner. therefore early warning systems (early warning scores= ews) have been developed from a set of several physiological measurements, signs and symptoms. individual parameters are weighted to sum up a score. based on this score, the deterioration of a patients' general condition may be indicated and a predetermined reaction from the professional staff be triggered (so-called track-and-trigger system). it is important to determine all parameters since missing values influence the informative value of an ews. this requires a higher effort by the staff and is one of the reasons why early warning systems are not yet used systematically in switzerland. a reduction in the number of parameters to be measured could lower the hurdle for the use of these tools and enable a broader applicability. therefore an early warning system shall be developed with a reduced number of physiological and individual parameters, compared to conventional early warning systems; and an algorithm will be generated that is able to predict clinical deterioration. its predictive power and accuracy shall be investigated, based on various clinical outcomes such as mortality, cardiac arrest, transfer to the intensive care unit or sepsis. retrospective, encrypted patient data (from 2016 until 2022) will be used to develop a statistical prediction model. in a second exploratory phase, different model variants will be analyzed and the applicability of the model variants in the context of continuous ews on wearables will be examined.

Eligibility criteria:
inclusion criteria: * hospitalized patients of surgical and medical wards of university hospital basel * hospital stay longer than 24 hours * signed general consent exclusion criteria: * patients admitted directly to the intensive care unit * rejection of general consent

Keywords: early warning score (ews) deterioration of patients' general condition
to evaluate safety, tolerability, pharmacodynamics, and pharmacokinetics of dwrx2003 against covid-19

Conditions: Healthy

Summary: this study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of niclosamide (dwrx2003) following escalating doses of dwrx2003 administered as an intramuscular injection in healthy volunteers.


Eligibility criteria:
inclusion criteria: 1. normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age. 2. volunteers who agree to give written informed consent and are willing to participate in the study. 3. volunteer having bodyweight minimum of 50 kg. 4. volunteer having body mass index of 18.50 to 29.90 kg/m2 (both inclusive). exclusion criteria: 1. known allergic to niclosamide or any component of the formulation and to any other related drug. 2. history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. 3. female volunteers who are nursing mothers/lactating women or are found positive in beta hcg test. 4. history/ current use of alcohol or drug abuse.
prospective evaluation of the diagnostic efficacy of a eus guided fnb needle (aquire®)

Conditions: Tumors of the Pancreas; Submucosal Tumor of Gastrointestinal Tract (Disorder); Lymph Node Disease

Summary: the present study investigates the efficacy of a new endoultrasound guided fine needle biopsy (eus-fnb) device (aquiretm boston scientific= aquire®) for obtaining histological tissue cylinders in the diagnosis of solid pancreatic tumors, submucosal tumors of the upper gastrointestinal tract (esophagus, stomach, duodenum) and lymph node disease..

the aquiretm fnb device uses a triple point tip that is designed to maximize tissue capture and minimize fragmentation. the efficiency of the 22 gauge needle is evaluated in a prospective single arm study. the material obtained will be collected for formalin fixation and analyzed by a pathologist blinded for the type of needle device.

Eligibility criteria:
inclusion criteria: * informed consent * indication for eus fnb with solid pancreatic tumors, submucosal tumors or lymph node disease of the upper gastrointestinal tract will be included exclusion criteria: * cystic pancreatic tumors * contraindication for eus fnb * lesion of interest cannot be reached endosonographically

Keywords: endosonography fine needle biopsy
predicting response to interventional pain management techniques in chronic low back pain in a prospective cohort.

Conditions: Low Back Pain; Pain Measurement; Chronic Pain; Analgesia, Epidural; Clinic, Pain

Summary: the main aim of this study is to identify factors that may be associated with a better or worse response to interventional pain management therapies for the treatment of chronic lumbar pain in adult patients. if several predictive factors are to be identified, a predictive model will be developed.

chronic lumbar pain is a common affection in the adult population, and an important source of chronic incapacity and impaired quality of life. there is a wide range of therapeutic options for the treatment of chronic lumbar pain. this study will analyze the response to several interventional pain management techniques and will search for factors that may be associated to a better or worse response to the techniques.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old with chronic lumbar pain to whom one of the following interventional pain management techniques has been indicated: * radiofrequency lumbar facet joint injection * radiofrequency lumbar facet joint denervation * lumbar epidural corticosteroid injection * caudal epidural corticosteroid injection * pulsed radiofrequency of the lumbar dorsal root ganglion * dorsal root ganglion injection exclusion criteria: * patients that have not undergone the interventional pain management technique. the interventional pain management technique is considered not performed if it is not done after a twelve month period after recruitment. * patients who are not willing to participate. * patients of whom it is impossible to obtain data of response. * patients who undergo low back surgery while they are in the study. * patients who suffer from an intercurrent disease that may interfere with the evaluation of chronic lumbar pain. * patients who suffer from myofascial pain syndromes. * patients who undergo pulsed radiofrequency denervation for the treatment of sacroiliac joint syndrome.