Kornimate/medical-research-clean huggingface dataset:
ziconotide effectiveness and safety trial in patients with chronic severe pain

Conditions: Pain

Summary: the purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.


Eligibility criteria:
inclusion criteria: * each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy. * each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline. * each patient must be able to respond to the visual analog scale of pain intensity (vaspi). * each patient must have an implanted programmable synchromed infusion device or a cadd-micro external programmable infusion device and spinal catheter (hereafter "it pump and spinal catheter") prior to enrollment into this trial. (if a patient has an external pump, the investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. the investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.) * each patient must be at least 18 years of age. * each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. reasonable accommodation of visually impaired patients will be allowed. * each patient is willing and able to comply with the protocol requirements. * each female patient of childbearing potential must agree to use adequate contraceptive methods while on prialt as determined by the investigator. exclusion criteria: * presence of pregnancy or lactation. * participation in another investigational drug or device trial within the preceding 30 days. * presence of known hypersensitivity to prialt or any of its components. * presence of any contraindication to continued it therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid \[csf\] circulation, or patient and caregiver inability to manage and protect the it pump and spinal catheter system and return for clinic follow up visits). * presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the investigator's opinion precludes the patient's ability to participate in this study.

Keywords: intrathecal
the comparison of postoperative pain after lumbar fusion surgery in intravenous patient-controlled analgesia between conventional mode and optimizing b.i mode with 'painstop' equipment

Conditions: Back Pain; Fusion of Spine, Lumbar Region; Spinal Stenosis

Summary: the postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (pca). the most common pain control method of this surgery is the intravenous (iv) pca. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of iv pca, may be failed to reduce the pain intensity effectively. consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. in addition, the patient's satisfaction to the pca may be low compared with that of expected. for the recently released pca instrument 'painstop', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (lot). furthermore, this device can be set to optimize basal infusion (b.i), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. therefore, this pca device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. however, since there are few studies related to this new mode of pca, more research is needed in patients with postoperative pain.


Eligibility criteria:
inclusion criteria: 1. the subjects who undergoing lumbar fusion surgery 2. asa class ⅰ-ⅲ 3. written consents obtained to participate voluntarily in this clinical trial exclusion criteria: 1. sudden change of surgical plan 2. patients who have the hypersensitivity to the pain killers including narcotics 3. patients who are unable to express the degree of pain

Keywords: lumbar fusion surgery patient controlled analgesia optimizing basal infusion mode
molecular imaging probes to inform heterogeneity in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of the study is to see if imaging with fluorine-18 fluorodeoxyglucose (\[18f\] fdg) and fluorine-18 displacement per atom (\[18f\]dpa-714) using positron emission tomography and computed tomography (pet/ct) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (ipf). this study may help physicians and researchers better understand how best to treat patients with ipf in the future.


Eligibility criteria:
inclusion criteria: 1. age between 40-85 years old. 2. a diagnosis of ipf that fulfills american thoracic society (ats) / european respiratory society (ers) 2018 consensus criteria within 5 years. 3. ability and willingness to give informed consent and adhere to study requirements. 4. ratio of forced expiratory volume in 1 second to forced vital capacity (fev1/fvc) \>0.70. 5. high or mixed affinity binder for tspo ligands based on genotyping for single-nucleotide polymorphism (snp)rs6971. exclusion criteria: 1. acute exacerbation of ipf within \<30 days 2. diagnosis of diabetes mellitus (type 1 or type 2). 3. diagnoses of current infection by clinical or microbial assessments. 4. treatment for \>14 days within the preceding month with \>20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant. 5. subjects with prior radiation therapy to the thorax. 6. women who are pregnant, or who are breastfeeding. ipf is a disease of older adults, and male predominant, so this will not be a frequent consideration. 7. severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke. 8. subjects with known liver disease. 9. diagnosis of any active cancer with the exception of basal cell carcinoma of skin. 10. low affinity binder for tspo ligands based on genotyping for snp rs6971. 11. active cigarette smoking or vaping
web-based follow-up to former icu patients

Conditions: Post Intensive Care Unit Syndrome

Summary: this study evaluates if a web-based 1-year programme is a useful method for follow-up intensive care survivors with short icu-stay. half of the participants are randomized into receiving the web-based follow-up while the other half will receive no follow-up.

it is not uncommon for intensive care survivors to have persisting, psychiatric, cognitive and physical impairments long time after the critical illness occurred. today, nurse-led follow-up is used but the main focus is on patients with a icu-stay for at least three days. this study evaluates icu-survivors with a maximum icu-stay for 72 hours. participants are randomized to the web-based one year follow-up programme and no follow-up. both group receive questionnaire 2, 6 and 12 month after the end of their intensive care stay. the web-based follow-up programme includes, short lectures that describes the intensive care e.g. hallucinations, memory loss and delirium. the programme also include short films that shows the medical equipment and how and why it´s used. regular contact with icu-nurse to discuss any upcoming problems.

Eligibility criteria:
inclusion criteria: * ≥18 years of age. * treated at the icu under the time of the study. * have a bank-id (which is needed to log in to the website.) exclusion criteria: * institutionalized due to severe cognitive deficit. * does not communicate in the swedish language. * patient is moved from other icu to icu where study is being held. * patient is sent to another icu from icu where study is being held. * no home address. * patient decline to participate in study. * patient is receiving psychiatric specialist care post-icu e.g. high suicide risk. * patient is receiving icu-treatment due to violence and is under on-going police-investigation. * palliative care. * patient receiving in-hospital care for more than 4 weeks in a row (except patient who is cared for in physical rehab-clinic at the hospital).

Keywords: intensive care units survivors web-based
the effect of duration between sessions on microperimetric biofeedback training in patients with maculopathies

Conditions: Macular Degeneration; Low Vision; Stargardt Disease

Summary: patients who develop macular diseases have several clinical complications,such as central vision loss, the central scotoma of the visual field, the decrease of reading speed and fixation stability. at present, there is still no satisfactory effect in the prevention and treatment of advanced macular disease. a new rehabitation strategy named microperimetric biofeedback training has been shown to be effective in improving patients' visual appearance, but there is no consensus regarding the optimal methodology and standard of practice. therefore, we designed a prospective clinical study to verify the effectiveness of mbft and to determine an optimal plan.

the present study aimed to investigate the effects of training frequency and number of training sessions on the visual outcomes of patients with various macular diseases. a total of 15 training sessions were conducted on two distinct frequencies, namely once a day and once every other day. baseline measurements included fixation stability, reading speed, and best corrected visual acuity (bcva) were obtained and followed up after the 5, 10, and 15 training sessions. by comparing the changes in these visual function parameters across different stages of training, the study aimed to identify and analyze the underlying patterns and rules governing the training process. ultimately, the results of this study could serve as a valuable reference for standardizing the use of mbft in clinical practice.

Eligibility criteria:
inclusion criteria: participants who (1) were diagnosed with macular disease and had a bcva poorer than 20/60; (2) with stable fundus lesion in fundus examinations; (3)with education level beyond the third grade; (4)had no other effective treatment; and (5)were willing to improve visual quality. exclusion criteria: who (1) received ocular treatments in the preceding 3 months, (2) with active fundus lesions like inflammation, bleeding, exudation, edema, (3) with obvious opacity of the refractive media such as keratopathy, severe cataract, or severe vitreous opacity, (4) were unable to attend scheduled follow-up appointments.

Keywords: macular disease low vision visual rehabilitation
prospective observation study of insulin sensitivity during and after gonadotropin releasing hormone agonist therapy for prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (gnrh agonist), affects the way the body produces and responds to insulin. the investigators will evaluate the changes in insulin sensitivity during and after gnrh agonist treatment for prostate cancer. the investigators are assessing the possibility that treatment-related insulin resistance may contribute to the risk of diabetes and/or cardiovascular disease in men with prostate cancer.

* the study will be divided into 2 groups: one group (cohort a) will consist of men undergoing gnrh agonist therapy for at least 24 months. the second group (cohort b) will consist of men undergoing the same treatment but who are scheduled to receive only 6 months of treatment. * the following tests and procedures will be performed when the participant joins the study, then at 3, 6, 12 and 24 months thereafter. (all visits will take place at the general clinical research center (gcrc) at the massachusetts general hospital.) height and weight; blood and urine samples; oral glucose tolerance test (ogtt), dual energy x-ray absorptiometry scan; medical history; and physical examinations.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate, clinical stage m0 * scheduled to initiate gnrh agonist therapy with intended treatment duration of greater than 24 months (group a) * scheduled for radiation therapy and neoadjuvant gnrh agonist therapy with intended 6 month duration of treatment (group b) * karnofsky performance status 90 or 100 * local or local-regional disease (group b) exclusion criteria: * prior hormone therapy (gnrh agonist or antiandrogen) * history of bilateral orchiectomy * known diabetes mellitus or glucose intolerance * current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels

Keywords: gnrh insulin sensitivity
the role of sub-mental ultrasonography in diagnosing obstructive sleep apnea and its correlation with subjective scales

Conditions: Obstructive Sleep Apnea; Diagnostic Imaging; Ultrasound

Summary: the investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of obstructive sleep apnea syndrome and the related specific subjective scales.

polysomnography (psg) is the gold-standard diagnose tool for obstructive sleep apnea (osa). however, the availability of psg is limited, particularly in developing and / or least developed countries. sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use. the investigators aimed to perform sub-mental ultrasonography to the patients who underwent to psg by a blind-to-the-psg-results radiologist and analyse the correlation between ultrasound measures, apnea-hypopnea index (measured by polysomnography) and subjective osa scales.

Eligibility criteria:
inclusion criteria: * patient who consented for sub-mental ultrasound exclusion criteria: * any pharyngo laryngeal anatomic abnormality * previous history of obstructive sleep apnea treatment * previous history of surgical intervention to the pharyngo laryngeal anatomic area

Keywords: sub-mental ultrasonography obstructive sleep apnea
immunonutrition to reduce toxicities in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer; NSCLC; Non-small Cell Lung Cancer; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage ⅢA; NSCLC Stage IIIB; NSCLC, Stage IIIA

Summary: the purpose of this study is to assess whether either or both nutrition supplements (impact® advanced recovery or boost® high protein) ingested prior to and during concurrent chemoradiotherapy decreases toxic side effects of treatment in stage iiia-b non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * patients will be recruited from the moffitt cancer center thoracic oncology outpatient clinic when identified by a thoracic oncologist that the patient will undergo all of their chemoradiotherapy at moffitt. * men and women ≥18 years of age. * diagnosed with unresectable stage iiia or iiib non-small cell lung cancer. * patients plan to undergo all cancer treatment at moffitt cancer center with definitive concurrent chemotherapy and radiotherapy. * no prior treatment of nsclc. * able to provide informed consent. * performance status 0, 1 or 2. * life expectancy \>3 months. * no esophagitis within 90 days. exclusion criteria: * mental incompetence or chronic psychiatric disease. * incarcerated individuals. * use of antibiotics or probiotic supplements within one month of chemoradiotherapy. * allergy to any of the components of impact® advanced recovery or boost® high protein. * pregnant female or breast-feeding. any female patient \<45 years old not using appropriate contraceptive measures during the treatment. * sepsis or active infection. * chronic renal failure stage iv (requiring protein restriction) or stage v requiring dialysis. * malnutrition defined as bmi \<16. * inflammatory bowel disease (ulcerative colitis or crohn's disease). * severe hepatic dysfunction (baseline prothrombin time off any anticoagulation of international normalized ratio (inr) \>1.8). * significant digestive disease with nausea, vomiting or diarrhea, nci grade \>1. * use of il-6 inhibitors (tocilizumab or siltuximab) within last 6 months.

Keywords: immunonutrition radiotherapy unresectable stage iiia-b lung cancer radiation oncology thoracic oncology epidemiology nutrition
cadonilimab in the treatment of advanced soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this study was to evaluate the efficacy and safety of cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma).

after being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period (≤28 days) to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be treated with cadonilimab monotherapy.

Eligibility criteria:
inclusion criteria: * 1. written and signed informed consent. * 2. male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent. * 3. pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, leiomyosarcoma, anigosarcoma, synovial sarcoma. * 4. patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma). exclusion criteria: * 1. prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. * 2. concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. * 3. prior exposure to any experimental antitumor vaccines, or any agent targeting t-cell costimulation or immune checkpoint pathways (eg, anti-pd-1, anti-pd-l1, anti-ctla-4, anti-cd137 or anti-ox40 antibody, etc). * 4. active autoimmune diseases; * 5. history of transplantation; * 6. known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (hiv).
validation of a new methodology for mapping the human blood-retinal barrier function

Conditions: Age-Related Maculopathy; Diabetic Macular Edema

Summary: to validate a new methodology, named retinal leakage analysis (rla), for mapping the human blood-retinal barrier (brb) function, in the clinical practice.


Eligibility criteria:
inclusion criteria: * patients diagnosed with amd, or * patients diagnosed with dme * age over 18 years * inform consent exclusion criteria: * cataract or other eye disease that may interfere with fundus examinations * glaucoma * dilatation of the pupil \< 5 mm
optimization of tuberculosis intradermal skin test

Conditions: Healthy Volunteers

Summary: the only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the mantoux method (also named tuberculosis skin test or ppd skin test). the tuberculin skin test is based on a delayed-type hypersensitivity skin reaction however, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the ppd skin test). the new generation bd micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel. a non-invasive and objective instrumental method of reading the test will be also tested .


Eligibility criteria:
inclusion criteria: * subject aged 18 years or over * tuberculosis skin test (ppd) * positive : 5mm =\<ppd\<15mm (24 subjects) * negative: ppd \< 5mm (6 subjects) * negative quantiferon test. * legal capacity to consent * subject had given written consent before his participation * subject accepting to participate in the second phase of the study with skin biopsies (24 subjects with positive ppd) * females of childbearing potential using an effective method of contraception, for at least 1 month before the beginning of the study and until 1 month after the end of their participation exclusion criteria: * known allergy to tuberculin * history of severe skin reaction to tuberculin with vesicle, ulceration, necrosis * history of active tuberculosis * latent tuberculosis (positive quantiferon test) * contact with a person having or having had active tuberculosis in the previous 3 months * chronic disease non-stabilized under treatment * immunosuppressive therapy or corticosteroids within 1 month before ppd skin tests * non-steroid anti-inflammatory drugs within 1 week before ppd skin tests * application on study areas of topical drugs containing corticoids or immunosuppressants within 1 week before ppd skin test * dermatological disease on study area * known allergy to local anesthetics * wound healing disorders * subject in an exclusion period or participating or planning to participate in another biomedical research

Keywords: delayed-type hypersensitivity reaction to tuberculin intradermal injection tuberculosis skin test bd micro-needle medical device spectroscopy
rectal and oral omeprazole treatment of reflux disease in infants.

Conditions: Gastroesophageal Reflux; Esophageal Atresia; Hernia, Diaphragmatic

Summary: the purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (gerd) in infants. infants, aged 0-12 months, require a non-standard dose of omeprazole. due to this fact extemporaneous formulations of omeprazole are administered to these infants. the oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. the dose range for gerd management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day. dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.this study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.

Eligibility criteria:
infants were eligible for the study if they were: * 6-12 weeks postnatal age * weighed more than 3 kg * were after surgical repair for ea or cdh * showed clinical gerd * were to undergo the 48 hour ph measurements. infants were excluded if they were: * allergic to omeprazole * participated in other interventional trials * used medications known to interact with omeprazole.

Keywords: omeprazole, suppository, infants