Kornimate/medical-research-clean huggingface dataset:
neoadjuvant camrelizumab, nab-paclitaxel and carboplatin in stage ib-iiia nsclc

Conditions: Lung Cancer, Non-small Cell; Artificial Intelligence

Summary: this prospective, single-arm, multicenter, phase ii trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. the mpr is the primary endpoint, and the pcr, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. the exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.


Eligibility criteria:
inclusion criteria: * the patients have stage ib-iiia nsclc. * patient ages are ≥ 18 years old, regardless of gender. * the patients have an ecog ps of 0-1, with a condition suitable for surgery. * the patients have not received any anti-tumor treatment. * the patients have adequate blood function. * the patients have adequate organ function. * the patients had been using an appropriate method of contraception, and there exists a negative pregnancy test (serum or urine) for women. * the patients will give their signed informed consent. exclusion criteria: * patients who had a prior allogeneic tissue or organ transplantation. * patients who have multiple cancers. * patients who have any severe or uncontrolled systemic diseases. * patients with a positive test for hiv, hbv, or hcv. * patients with severe infection or with an infection that required antibiotic therapy. * patients with a history of interstitial lung disease, active tuberculosis, or autoimmune disease. * patients who have participated in any other clinical trials. * patients who are considered ineligible by the investigator.

Keywords: non-small cell lung cancer neoadjuvant therapy immune checkpoint inhibitor major pathological response artificial intelligence
a study to evaluate the efficacy and safety of shr-1703 in subjects with eosinophilic granulomatosis with polyangiitis （egpa）

Conditions: Eosinophilic Granulomatosis With Polyangiitis

Summary: this study is a phase 2/3 clinical trial to evaluate the efficacy and safety of shr-1703 in patients with egpa.


Eligibility criteria:
inclusion criteria: 1. male or female subjects age 18 years or older; 2. diagnosed with egpa for at least 6 months; 3. history of relapsing or refractory egpa； 4. stable dose of oral prednisone of ≥7.5 mg/day (but not \>50 mg/day) for at least 4 weeks prior to randomization; 5. if receiving immunosuppressive therapy (excluding cyclophosphamide), the dosage must be stable within 4 weeks prior to randomization and during the study. exclusion criteria: 1. subjects with other eosinophilic-related diseases; 2. diagnosed with granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa). 3. life-threatening egpa within 3 months prior to randomization; 4. malignancy history within 5 years prior to randomization; 5. immunodeficiency; 6. uncontrolled hypertension； 7. uncontrolled cerebrovascular and cardiovascular disease; 8. parasitic infection within 6 months prior to randomization; 9. active infectious disease requiring clinical treatment within 4 weeks prior to randomization; 10. subjects with a dose of oral prednisone of \>50 mg/day within 4 weeks prior to randomization; 11. oral or intravenous cyclophosphamide therapy within 4 weeks prior to randomization; 12. intravenous or subcutaneous immunoglobulin within 12 weeks prior to randomization; 13. biological agents or th2 cytokine inhibitors used within 12 weeks prior to randomization or within 5 half-lives of the drug; 14. rituximab or alemtuzumab used within 12 months prior to randomization； 15. surgical plans that might affect the evaluation; 16. significant laboratory abnormalities； 17. prolonged qtc interval or other electrocardiogram abnormalities with significant safety risk at screening; 18. history of drug or substance abuse or alcohol abuse within 1 year prior to screening; 19. subjects participated another clinical study and received active drug within 30 days or 5 half-lives of the drug prior to screening; 20. subjects is pregnant, lactating, or planning to be pregnant; 21. subjects have a known history of hypersensitivity or intolerance to anti-il-5 mabs or other biological agents; 22. other conditions unsuitable for participation in the study per investigator judgement.
act1vate: addressing emotional distress to improve outcomes among diverse adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this research will compare a psychological intervention ("act1vate") versus diabetes self-management education and support (dsme/s; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (t1d) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

this randomized controlled trial will compare a telemedicine psychological intervention specifically designed to address diabetes distress ("act1vate") versus traditional diabetes self-management education and support (dsme/s; usual care) in improving glycemic control among n=250 adults with type 1 diabetes (t1d), glycosylated hemoglobin (hba1c) between 7.5% - 12.5% in the last 90 days, and significant diabetes distress. capitalizing on existing and real-world processes, the electronic health record (ehr) will be used to identify eligible patients and examine primary outcomes. participants randomized to the usual care group will be offered standard, 1:1 dsme/s delivered by a certified diabetes care and education specialist via telemedicine format. participants randomized to the act1vate group will be offered 5 group-therapy telemedicine sessions delivered by a behavioral health provider who is an integrated member of the diabetes care team. act1vate is grounded in acceptance and commitment therapy (act), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. the primary clinical outcome, hba1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the ehr over 12 months. changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12. a thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient and provider perspectives. cost-effectiveness will also be examined from the health system perspective. by maximizing integration with routine medical care for t1d in a real world, healthcare environment, results will be highly generalizable and hold great potential to inform the future of care for adults living with t1d.

Eligibility criteria:
inclusion criteria: * spanish or english-speaking * type 1 diabetes * glycosylated hemoglobin (hba1c) 7.5% - 12.5% in last 90 days * screen positive for diabetes distress exclusion criteria: * severe medical or psychological conditions that would interfere with participation based on the opinion of a provider * plans to move out of the san diego area in the next 12 months * lack of technology capability required to complete online surveys and telemedicine visit

Keywords: type 1 diabetes emotional distress
rotator cuff reconstruction with xenologous dermis-patch augmentation and acp® - injection

Conditions: Rotator Cuff Tears

Summary: the purpose of this study is to show that an augmentation with the dx reinforcement matrix from arthrex is possible with the arthroscopic technique.

the shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. if the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. the patients in this study have 60 years or more. the tissue of these patients isn't as good as in young patients. the patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. additionally the investigators can boost the healing process with a selective use of prp (prp = platelet rich plasma). in this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them.

Eligibility criteria:
inclusion criteria: * arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by dr. flury * age: 60 years or more * suture bridge technique * women: no longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically ovaries and/or uterus removed surgically) * signed consent form exclusion criteria: * partial reconstruction of the rotator cuff (pasta) * open reconstruction * tendon transfer (latissimus dorsi or pectoralis major) * revision surgery * omarthrosis (level ≥ 2 samilson \& prieto) * systemic arthritis * rheumatoid arthritis * diabetes (insulin treated) * requiring surgery in reconstruction of the subscapularis tendon * progressive fat inclusion (fatty infiltration of the rotator cuff musculature goutallier level iv * acute or chronic infection * pathological bone metabolism * insufficient perfusion in the affected arm * neuromuscular disease in the affected arm * non compliance of the patient * disorders which handicap or inhibit the patient to follow the orders of the clinical testers

Keywords: rotator cuff tears acp dx reinforcement matrix
pilot study evaluating interruption of enfuvirtide (fuzeon, t20) in patients with enfuvirtide resistance

Conditions: HIV Infections

Summary: the goal of this study is to examine whether enfuvirtide (t20, fuzeon) has continued anti-hiv activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.

some patients do not achieve an undetectable hiv viral load with an enfuvirtide (t20, fuzeon) based antiretroviral regimen. as a consequence, enfuvirtide resistant virus can emerge. it is not yet known if enfuvirtide has continued virologic or immunologic benefit after the drug-resistant variant emerges. interrupting enfuvirtide may reduce the accumulation of enfuvirtide mutations and may allow for a potent response of enfuvirtide with future regimens. subjects must have evidence of viral replication (hiv rna \> 1,000 copies/ml on two consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide. patients will then interrupt enfuvirtide while continuing all other antiretroviral agents. subjects will be seen weekly for four weeks, every two weeks for an additional 8 weeks, and then every four weeks through week 48. plasma hiv rna levels and cd4+/cd8+ t cell counts will be measured in real time at each visit, and provided to the referring primary care physician. subjects will be allowed to resume enfuvirtide at any time during the course of this study. subjects will be encouraged to resume enfuvirtide (with or without modifying the background regimen) if plasma hiv rna levels increase by \> 0.5 log on two consecutive occasions. subjects are seen every four weeks for 24 weeks after enfuvirtide is resumed. plasma will be collected at those visits for hiv rna and stored for retrospective genotype/phenotype evaluation.

Eligibility criteria:
inclusion criteria: * currently receiving continuous enfuvirtide-based antiretroviral therapy. * documentation of recent plasma hiv rna level greater than the lower limit of detection (measured within the preceding 4 weeks) * screening plasma hiv-1 rna level \> 1000 copies/ml. * negative serum pregnancy test (for women of childbearing potential) documented within the 14-day period prior to study entry. * subjects must be able to give written informed consent and agree to abide by the requirements of the study. exclusion criteria: * unstable hiv disease status such that interrupting any antiretroviral therapy poses significant short-term risk for disease progression (as determined by study investigators and referring primary care provider). * female subjects who are pregnant, breastfeeding, or who plan to become pregnant during the study. * active hepatitis c infection requiring treatment with an interferon-based regimen. * evidence of active, untreated opportunistic infections or unexplained temperature which is \> 38.5°c for seven consecutive days, within 30 days prior to the first screening visit.

Keywords: enfuvirtide t20 fuzeon treatment interruption resistance hiv drug resistance antiretroviral agents salvage therapy drug resistance, multiple human immunodeficiency virus
pediatric early autism recognition system: pears

Conditions: Autism Spectrum Disorder

Summary: the goal of the study is to assess a new autism evaluation model that would include the addition of a level-2 autism screener, the rapid interactive screening test for autism in toddlers (rita-t), to the developmental screening already done by the child's pediatrician. the study hypotheses: 1. the pears intervention will show high feasibility to primary care physicians (pcps) and patient families. 2. the pears intervention will lead to increased parent activation around autism diagnosis.


Eligibility criteria:
inclusion criteria- child: * increased risk for autism spectrum disorder (asd) defined as: * positive modified checklist for autism in toddlers-revised (mchat) (score greater than 3); * or having a sibling or parent with asd; * or history of prematurity (gestational age less or equal 34 weeks); * or other provider or parent concern for asd. * child age 18-36 months exclusion criteria- child: * previous asd diagnosis * previous negative asd evaluation * known seizure disorder * vision impairment * hearing impairment inclusion criteria- parent - parent or legal guardian of the children exclusion criteria- parent - not a parent or legal guardian of the child

Keywords: early diagnosis
integrated mental health care and vocational rehabilitation to individuals on sick leave due to anxiety and depression

Conditions: Generalized Anxiety; Social Phobia; Panic Disorder; Depression

Summary: the purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in denmark

background: depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in denmark have common mental disorders like depression and anxiety. there is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. integrated vocational and health care services have shown good effects on return to work in other scandinavian countries. objective: the purpose of the danish ibbis study is to examine the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in denmark. method: this three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in denmark. 603 patients are recruited from danish job centers in four municipalities. the primary outcome is return to work at 12 months. results/discussion: this study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a scandinavian context.

Eligibility criteria:
inclusion criteria: * depression, generalized anxiety, social phobia or panic disorder according to mini international neuropsychiatric interview (mini) * on sick leave from work or unemployment and have received sick leave benefit for minimum four weeks or have started a sick leave benefit case which is estimated to last for minimum eight weeks * citizen in one of the following municipalities: copenhagen city, gladsaxe municipality, lyngby-taarbæk municipality or gentofte municipality * danish-speaking * given informed consent exclusion criteria: * pregnant * high degree of suicidal ideation * dementia * alcohol or substance misuse that hinders the person participating in treatment * wish to start or continue psychological therapy * need for psychiatric treatment in the secondary psychiatric care system * medically unstable to a degree that the patient cannot adhere to treatment * participant in the research project collabri * attending stress courses in the stress clinics of copenhagen city * assessed by job center case managers to be dangerous

Keywords: vocational rehabilitation anxiety depression common mental disorders cognitive behavior therapy return to work mental health services integration
alcohol-roc-training

Conditions: Binge Drinking; Heavy Drinking; Young Adult; Heavy Drinker

Summary: the goal of the proposed study is to examine whether brief training in regulation of craving (roc-t) affects alcohol drinking. the study will consist of a basic screening (phone and online), and in person visit to determine eligibility and conduct pre-intervention baseline assessments, 1-4 training (roc-t) visits, a post-intervention assessment visit, and 1-2 phone/online follow up assessments.the two active conditions of roc-t are based on cognitive-behavioral treatments (cbt) and mindfulness-based treatments (mbt).

this is a stage 1b randomized-controlled trial (rct). 177 heavy drinking young adult participants will be randomized to 4 x 45-minute web-based sessions of (1) cbt-roc-t training, (2) mbt-roc-t, or (3) control (no strategy) delivered over three weeks. participants will be enrolled for 16 weeks (three weeks pre-, three weeks during, and ten weeks post-intervention).

Eligibility criteria:
inclusion criteria: (1) young adults ages 18-26 years, who (2) report ≥ 3 heavy drinking days (i.e., heavy drinking defined by \>3 drinks for women, \>4 drinks for men) in the prior month; (3) are motivated to quit or reduce drinking; (4) are fluent in english and have a 6th grade or higher reading level; (5) have access to a computer with working internet; (6) use a working smartphone; (7) can commit to the full length of the protocol; and (8) are willing to be randomized to intervention condition. exclusion criteria: (1) current (past 12 months) clinically-severe alcohol use disorder (aud; e.g., history of seizures, delirium, or hallucinations during withdrawal) or current severe alcohol withdrawal; (2) current (past 12 months) clinically-severe substance use disorder (except tobacco) or current severe drug withdrawal; (3) serious other psychiatric illness by history or examination; (4) severe or unstable physical disease within the past 6 months; (5) psychoactive medications (e.g., mood stabilizers) that have not been at a stable dose unless determined to be on a stable dose of medication by the study psychiatrist; (6) current use of any investigational medication; (7) color blindness; (8) biological females who are pregnant; and (9) notable dislike to any particular type of alcoholic beverage depicted in study stimuli; (10) participants who will not complete at least 70% of past day ema reports in the pre-intervention phase will not be randomized; (11) participants who cannot understand or follow study-related instructions (e.g., unable to correctly use the intervention strategies, indicate lack of understanding of study instructions despite multiple attempts).

Keywords: binge drinking heavy drinking young adult heavy drinker regulation of craving cognitive behavioral therapy neurocognitive training mindfulness-based therapy
pain reduction in maxillomandibular surgery using maxillary and mandibular nerve blocks

Conditions: Pain, Post Operative; Regional Anesthesia

Summary: maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. this study is designed to evaluate analgesic effectiveness, through opioids consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.

maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. it mostly requires opioids use which lead to well known side effects. regional anesthesia has strongly modified post-surgical rehabilitation of many procedures. maxillary nerve block has proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but has been rarely evaluated in orthognathic surgery. mandibular nerve block has never been investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound guided technique to perform these nerve blocks. consequently, this trial is designed to evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy. this monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25 patients receiving either bilateral double ultra-sound guided nerve block (maxillary and mandibular) with ropivacaine 4.75mg/ml either local infiltration of lidocaine 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. per et post-surgery anesthesic protocol and analgesia are standardized for both group. the main outcome corresponds to opioid consumption in mme of the first 24h after surgery. follow-up occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.

Eligibility criteria:
inclusion criteria: * patients from 15 to 45 years old, * scheduled for maxillary-mandibular osteotomy, * registered in french social insurance register, * with informed consent disclosure. exclusion criteria: * american society of anesthesiologists (asa) classification ≥ 3 * innate or acquired hemostasis pathology, * peripheric neuropathy, * drug intake for chronic pain, * infection/scar at needle insertion site, * associated rhinoplasty surgery, * allergy to local anesthetics, * pregnant woman or potentially, * breastfeeding woman, * already registered in other clinical trial, * adults under legal protection of incapable adult, * cognitive disease impairing using of evaluation tools performed in protocol, * all contraindication of anesthetics drugs used in protocol.

Keywords: orthognathic surgery maxillary-mandibular osteotomy double jaw osteotomy bimaxillary surgery maxillary nerve block mandibular nerve block regional anesthesia nerve blocks