Kornimate/medical-research-clean huggingface dataset:
lung diffusing capacity for nitric oxide and carbon monoxide after hematopoietic stem-cell transplantation

Conditions: Lung Disease

Summary: early after allogeneic hematopoietic stem-cell transplantation (allo-hsct), reductions of absolute lung volume and diffusing capacity for carbon monoxide (dlco) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (ips). it can be hypothesized that these changes might be due to an occult intersitial lung disease associated with infections, acute graft-versus-host disease (agvhd), myeloablative conditioning regimens or any combination of these. to test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (dlno) and dlco and estimate the changes of membrane diffusing capacity (dm) and pulmonary capillary volume (vc) by the dlno/dlco ratio. as we hypothesize that ghvd should be intuitively absent amongst autologous hsct (auto-hsct) recipients, we will compare the changes in dlno/dlco ratio showed by the latter group with those of subjects undergoing allo-hsct.

in allogeneic hematopoietic stem-cell transplantation (allo-hsct) recipients, early reductions of absolute lung volume and diffusing capacity for carbon monoxide (dlco) are frequently detected even in the absence of overt idiopathic pneumonia syndrome (ips)\[pmid: 22221781\]. two months after allo-hsct, we have recently shown an increase in lung tissue density determined by quantitative ct scan \[pmid: 22898044\]. it can be hypothesized that these parenchymal changes might be due to an occult intersitial lung disease associated with infections, acute graft-versus-host disease (agvhd), myeloablative conditioning regimens or any combination of these \[pmid: 21531955\]. to test this hypothesis, we will simultaneously measure the lung diffusing capacity for nitric oxide (dlno) and dlco. assuming, for clinical purposes, that the reaction rate of no with blood hemoglobin is infinite so that dlno = dmno = dmco\*alpha (alpha = no/co diffusivity ratio), as to partition the effect of hsct on membrane diffusing capacity (dm) and pulmonary capillary volume (vc) we will use the dlno/dlco ratio \[pmid:16478855\]. as we hypothesize that ghvd should be intuitively absent amongst autologous hsct (auto-hsct) recipients, we will compare the changes in dlno/dlco ratio showed by the latter group with those of subjects undergoing allo-hsct.

Eligibility criteria:
inclusion criteria: * baseline spirometry, lung volumes, and dlco of the subjects included in the analysis must be within the predicted normal range * all patients must be in stable clinical conditions at the time of study exclusion criteria: * a history of bronchial asthma, chronic obstructive pulmonary disease, or other significant respiratory disease

Keywords: allogeneic and autologous hematopoietic stem-cell transplantation lung diffusing capacity for nitric oxide carbon monoxide lung tissue density microvascular damage
an open label extension study to evaluate the safety of continued therapy of subcutanous remodulin® in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this is a multicenter, open-label trial to evaluate the safety of continued therapy with subcutaneous remodulin® in subjects with pulmonary arterial hypertension (pah) who complete the cvt-cv-003 study. the study will include about 50 subjects at up to 10 clinical trial centers in china who completed all required assessments in the cvt-cv-003 study. study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor.


Eligibility criteria:
inclusion criteria: a subject is eligible for inclusion in this study if all of the following criteria apply: 1. the subject voluntarily gives written informed consent to participate in the study. 2. the subject participated in and completed study cvt-cv-003. 3. sexually active women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception. medically acceptable forms of effective contraception include: (1) approved hormonal contraceptive (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (iud), or (4) partner vasectomy. women of child bearing potential include any females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months). males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication. 4. the subject has not developed a concurrent illness or condition during the conduct of the previous study (including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left sided heart disease) that would make participation in this study detrimental to the subject's health in the opinion of the investigator. 5. in the opinion of the principal investigator, the subject is able to communicate effectively with study personnel, is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits, and is mentally and physically capable of administering remodulin by continuous sc infusion using a micro infusion pump. exclusion criteria: a subject is not eligible for inclusion in this study if any of the following criteria apply: 1. the subject permanently discontinued remodulin during study cvt-cv-003. 2. the subject is pregnant or lactating.

Keywords: pah subcutaneous treprostinil remodulin 6 minute walk test
analgesia by single or dual acupoints stimulation after radical mastectomy

Conditions: Pain

Summary: the purpose of this study is to compare the effects of dual acupoints and single acupoint transcutaneous electrical acupoint stimulation (teas) pretreatment on incidence of post-mastectomy pain syndrome(pmps) in patients undergoing operation of breast cancer.

patients were randomly assigned to three groups, receiving 30min teas before anesthesia respectively. the acupoints of dual point group are bilateral neiguan points(pc6) combined with danzhong point(rn17), single point group is bilateral neiguan points(pc6), and the false stimulation group only attach electrodes without electric current. the frequency of teas is set to 2/15 hz. intraoperative anesthetic dosage of propofol and remifentanil was recorded. three and six months after surgery, follow-up about chronic pain was made by telephone or face-to-face using the follow-up questionnaire. the adverse events were recorded.

Eligibility criteria:
inclusion criteria: * scheduled for operation of breast cancer； * asa（american society of anesthesiologists）i-ii； * aged between 18 and 65； * informed consented。 exclusion criteria: * suffered from the contraindication of teas including the local skin breakage, infection or planted with the electrophysiology device； * unable to communicate and coordinate with the researcher, such as suffering from language comprehension deficits or mental diseases； * certain/suspicious addiction with alcohol, analgesics or other drugs； * unstable angina or myocardial infarction occurred in 3 months; nyha（new york heart association） is 3 or higher; * blood pressure ≥ 180/110 mm hg while preoperative visiting; * suffered from diabetic complications including diabetic ketoacidosis, hyperosmolar coma, infection, macroangiopathy, diabetic nephropathy, retinopathy, cardiomyopathy, neuropathy and diabetic foot; * severe dysfunction of liver or kidney meaning one of alt（alanine transaminase）, ast（aspartate transaminase）, alp（alkaline phosphatase） or tbil（total bilirubin） is 2 times higher that normal or creatinine clearance \ 177umol/l; * participate in the other clinical trial 3 month before the enrollment.
transcranial direct current stimulation and computer-based training for the traumatic brain injury rehabilitation

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. therefore, rehabilitation is of utmost importance. the increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (dlpfc) is related to better performance in functional memory. in this context, transcranial direct current stimulation (tdcs), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including tbi by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. in addition, studies have shown greater benefits when the technique is combined with cognitive training. therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tdcs applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tdcs on cognitive function of individuals with severe chronic tbi.


Eligibility criteria:
inclusion criteria: * chronic tbi (≥ 12 months) * severe tbi (glasgow ≤ 8, loss of consciousness \> 24 hours, post-traumatic amnesia \> 1 week) * working memory, attention or executive deficit * score in mini mental state examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling). exclusion criteria: * individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis) * mid or extensive cranial defects * titanium cranial prosthesis * extensive cranial prosthesis located on the dorsal prefrontal cortex * metallic devices implanted in the brain * psychotic disorders * recent history of alcoholism or use of drugs * neurological diseases (e.g parkinson, stroke, alzheimer).

Keywords: traumatic brain injury transcranial direct current stimulation computer-assisted training cognitive training cognitive function executive function working memory attention
real-world immuno-radiotherapy for advanced nsclc

Conditions: Lung Cancer Non-Small Cell Cancer (NSCLC)

Summary: the optimal combination strategy for radiotherapy combined with immunotherapy (irt) in advanced non-small-cell lung cancer (nsclc) remains unclear, and there is a lack of real-world data to validate its efficacy. the objective of this study is to confirm the survival benefits of irt in advanced nsclc and to identify the optimal combination strategy for its use.

the pacific study has established radiotherapy combined with immune checkpoint inhibitors (irt) as the primary treatment modality for unresectable, locally advanced non-small-cell lung cancer (nsclc). simultaneously, the keynote-001 study provided evidence supporting the efficacy of irt in patients with metastatic and progressive nsclc. however, most available evidence comes from interventional clinical trials, where participants are rigorously selected and required to adhere strictly to protocol-defined interventions. this creates a significant gap in real-world data, which is essential to further validate the survival benefits of irt in advanced nsclc. furthermore, clinical trials evaluating concurrent irt in nsclc have largely yielded negative or inconclusive results, highlighting the need for clarity on the optimal combination strategy for irt. to address these gaps, researchers will conduct a territory-wide real-world cohort study. the objective of this study is to validate the survival benefits of irt in patients with advanced nsclc and to identify the optimal sequential strategy for irt.

Eligibility criteria:
inclusion criteria: * nsclc patients who received immunotherapy between 2015 and 2021 * for unresectable locally advanced nsclc: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after rt or concurrently with rt * for de novo metastatic nsclc: radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days after rt or concurrently with rt * for post-treatment progressive nsclc: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy * age \>= 18 years old exclusion criteria: * patients with multiple primary cancers or a pathological diagnosis of small cell lung cancer * patients who did not receive radiotherapy or who did not undergo radiotherapy within 90 days before or after immunotherapy

Keywords: advanced nsclc icis radiotherapy irt
exisulind versus placebo after surgical removal of the prostate

Conditions: Prostatic Neoplasms

Summary: this is a study in which patients with prostate cancer treated by surgical removal of the prostate and considered to be at risk for prostate cancer recurrence will receive exisulind 250 mg twice a day or placebo twice a day for two years.


Eligibility criteria:
males 18 years of age or older with prostate cancer treated primarily by radical prostatectomy and randomized within 45 days after surgery may be eligible for enrollment into this protocol. participants cannot have had hormonal therapy, cryotherapy, thermotherapy, or radiotherapy prior to entering the study.
the safety and effectiveness of zidovudine plus adefovir in hiv-infected patients

Conditions: HIV Infections

Summary: to study the safety, tolerance, pharmacokinetics, and anti-hiv effects of combination zidovudine (azt) and pmea (adefovir) therapy.

patients receive azt daily and intravenous pmea three times weekly for 4 weeks. an mtd will be defined for this regimen.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (bactrim, septra) or dapsone, and fluconazole or ketoconazole if on a stable regimen for at least 4 weeks prior to study entry. patients must have: * hiv seropositivity. * mean cd4 count \<= 500 cells/mm3. * been receiving azt at 500 mg daily for at least 4 weeks prior to study entry. * life expectancy of at least 3 months. note: * kaposi's sarcoma is permitted provided patient has not received any systemic therapy for ks within the past 4 weeks. patients with a history of another malignancy must be disease free for 6 months or more prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * inadequate venous access. * active, serious infections (other than hiv infection) requiring parenteral antibiotic therapy. * clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or clinically significant arrhythmia. * active malignancy other than kaposi's sarcoma. * mental incapacity or illness that may affect compliance. concurrent medication: excluded: * ddi or ddc. * interferon alpha. * ganciclovir. * foscarnet. * diuretics. * investigational agents including d4t. * chemotherapeutic agents. * amphotericin b. * aminoglycoside antibiotics. * other nephrotoxic agents. * immunomodulatory agents. * parenteral therapy for an active, serious infection (other than hiv infection). prior medication: excluded within 2 weeks prior to study entry: * ddi or ddc. * interferon alpha. * ganciclovir. * foscarnet. * diuretics. * investigational agents including d4t. * chemotherapeutic agents. * amphotericin b. * aminoglycoside antibiotics. * other nephrotoxic agents. * immunomodulatory agents. excluded within 4 weeks prior to study entry: systemic therapy for kaposi's sarcoma. required: * azt at a stable dose for at least 4 weeks prior to study entry. current use of illicit drugs (e.g., heroin or cocaine). ingestion of substantial alcohol.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents zidovudine adenine
safety, tolerability and pharmacokinetics of arct-810 in healthy adult subjects

Conditions: Ornithine Transcarbamylase Deficiency

Summary: determine the safety, tolerability and pharmacokinetics of single doses of arct-810 in healthy adult subjects.

this is a single ascending dose study of arct-810 in which approximately 30 subjects are planned to be enrolled. the length of each study participant is approximately 8 weeks from screening to last study visit. study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of arct-810. there will be 6 participants in each group. within each cohort, subjects will be randomized 2:1 to receive arct-810 or placebo as an iv infusion.

Eligibility criteria:
inclusion criteria: 1. healthy males or females aged 18 to 65 at the time of informed consent. 2. body weight ≤ 100kg and body mass index \<35 kg/m2 3. willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits and willing to refrain from taking protein supplements for the duration of the study. 4. willing and able to comply with protocol-defined procedures and complete all study visits 5. males must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of study drug. females: must be non-pregnant and non-lactating and either: i. surgically sterile or ii. post-menopausal exclusion criteria: 1. clinically significant abnormalities in medical history 2. screening laboratory results as follows: * alt, ast, ggt, total bilirubin or alkaline phosphatase, \> uln. * random blood glucose and/or hba1c \> uln * hemoglobin \< lln * platelet count \< 100x109/l * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 calculated by modification to diet in renal disease \[mdrd\] study equation. * urine protein:creatinine ratio (upcr) \> 50 mg/mmol 3. active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to study day 1 4. known history of or positive test for human immunodeficiency virus (hiv), hepatitis c or chronic hepatitis b 5. uncontrolled hypertension (bp \> 160/100 mm hg) 6. treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer 7. recent (within 1 year) history of, or current drug or alcohol abuse 8. have any other conditions, which, in the opinion of the investigator or sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
renew-ai: personalizing scleroderma management with an ai health coach

Conditions: Scleroderma

Summary: the purpose of this pilot study is to explore the use of a large language model (llm) in providing education and behavioral health coaching for individuals with systemic sclerosis (ssc). the goal of the llm is to help user set or modify behavioral goals, provide education, or emotional support as needed by the participant. the primary outcome for this study is to assess the feasibility and acceptability of using an ai-supported health coaching tool over a four-week period.

the study is supported by dan barry trainee research program through the department of physical medicine and rehabilitation at michigan medicine.

Eligibility criteria:
inclusion criteria: * participants from our previous clinical trial, who received the original renew intervention (n=66), will be invited to participate in this study. * participants who have a medical diagnosis of systemic sclerosis, any subtype (diffuse, limited, sine, or overlap) * participants who report a mean score 4 or more on the fatigue severity scale, indicative of problematic fatigue; potential mean range 1-9 * participants who have access to a computer and an internet connection * participants who are able to speak and read english. exclusion criteria: * individuals who did not participate in the original renew trial * individuals who lack access to reliable high-speed internet will be excluded to ensure they can fully engage with the ai-supported health coaching and digital components of the study * non-english speakers will be excluded because the current version of the ai tool is available only in english * individuals planning to initiate any new treatments specifically targeting fatigue, pain, or mood symptoms (such as psychological therapy, structured rehabilitation, or new medications) during the 4-week study period will be excluded, to avoid confounding effects on the study outcomes. * individuals with other significant medical or logistical issues that would impede meaningful participation, such as severe concurrent medical conditions, inability to access the renew intervention, or cognitive impairments that prevent them from engaging with study procedures, will also be excluded.

Keywords: systemic sclerosis
agitation follow up after introduction of a new patient care algorithm

Conditions: Agitation,Psychomotor

Summary: agitation in the intensive care unit is motor hyperactivity. it is frequent (b/w 30% to 70%) and has multiple causes: pain, medical reason, delirium, medication, etc. it can be a source of complication, for the patient, and equipment pullout. international recommendations state that the agitation should be taken care of with standardized protocols to improve patient care.

data regarding patient characteristics and evaluation criterion will be collected automatically with the unit software (ccc, general electrics) in specific file. care and health teams enter the data systematically following the usual protocol. first step : follow-up and collection of data of patients included. agitation evaluation with rass scale, pain evaluation with bps or nprs. second step: team training to delirium evaluation scale (cam-icu) and to the use of care algorithm. third step: follow-up and collection of data of patients included. use of care algorithm by doctors, nurses and back up training nurse to ensure daily information to health professionals of the care unit. concomitant step: post discharge from care unit medical appointment to evaluate anxiety symptoms (had scale) and quality of life (sf-12)

Eligibility criteria:
inclusion criteria: * patient presenting an agitation episode (rass\>1) * intensive care unit hospitalization * patient or next of kin if patient not able non opposed on participating to the study exclusion criteria: * decision to limit life-sustaining therapy * brain damage * moribund patient * patient participating to another trial excluding observational studies * the patient is pregnant or a lactating female * patient under tutorship or curatorship and liberty deprived

Keywords: rass cam-icu