Kornimate/medical-research-clean huggingface dataset:
optimal postoperative pain management after lung surgery (optrial)

Conditions: Lung Cancer; Pain, Postoperative; VATS; Locoregional Anaesthesia; Thoracic Epidural

Summary: adequate pain control after video-assisted thoracoscopic surgery (vats) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. so far, no consensus exists on optimal postoperative pain management after vats anatomic lung resection. thoracic epidural analgesia (tea) is the reference standard for postoperative pain management following vats. although the analgesic effect of tea is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. these disadvantages of tea initiated the development of unilateral regional techniques for pain management. the most frequently used techniques are continuous paravertebral block (pvb) and single-shot intercostal nerve block (icnb). the investigators hypothesize that using either pvb or icnb is non-inferior to tea regarding postoperative pain and superior regarding quality of recovery (qor). signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) * patients referred for anatomic lung resection (pneumonectomy, (bi)lobectomy or segmentectomy for either benign or malignant disease) with the intention of performing it by video-assisted thoracoscopic surgery (vats) or robot-assisted thoracoscopic surgery (rats) * patients should be able to provide informed consent and fill out questionnaires in dutch language. exclusion criteria: * patients with contra-indications for tea or pvb (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, bridging indication for therapeutic anticoagulation (chads-vasc ≥ 8), sepsis and mechanical spine obstruction) or allergic reactions to local anaesthetics will be excluded. * patients chronically using opioids for reasons not related to the operation will be excluded from the study since postoperative baseline opioid requirement will be higher and tea remains the preferred technique for these patients. * in case the lung surgeon estimates the operation to be performed through a thoracotomy instead of vats/rats
bioavailability, safety, and tolerability of bis-001 er

Conditions: Epilepsy, Complex Partial

Summary: this study investigates the safety, tolerability, and pharmacokinetics of bis-001 er in healthy volunteers. subjects will be dosed twice daily, with a dose escalation occurring every 2-3 days until a maximum dose of 5mg per day is reached.


Eligibility criteria:
inclusion criteria: 1. speak english with sufficient proficiency to read and comprehend the informed consent document, and to communicate with study staff. 2. be able to consent to participate by signing the informed consent document after a full explanation of the nature and purpose of this study. 3. have signed the informed consent before any study-specific procedures are performed 4. be males or females between 18 - 45 years of age. 5. have a negative urinary pregnancy test upon admission to the site on day 1 6. be in good general health in the judgment of the principal investigator based upon medical history, physical examination, standard 12-lead electrocardiogram (ecg), and clinical laboratory evaluations obtained within the two weeks prior to enrollment. 7. be able to comply with all study-specified procedures. 8. weight between 40 and 100 kg exclusion criteria: 1. has taken huperzine a. 2. is planning to become pregnant or impregnate spouse, not using an acceptable method of birth control (defined as use of double-barrier birth control methods, use of oral contraceptives, or surgical sterilization), pregnant or nursing 3. has a pre-existing medical condition (including an existing progressive or degenerative neurological disorder) or takes medications that, in the principal investigator's opinion, could interfere with the subject's suitability for participation in the study. 4. has a history or evidence of significant psychiatric disturbance or illness, including alcohol or drug abuse within the past 2 years, or symptoms of psychosis (hallucinations, delusions) in the last 5 years. 5. has had any clinical laboratory abnormalities within the past two months, prior to screening, considered of clinical significance by the principal investigator 6. is on concomitant therapy with non-anti-epileptic drugs (aeds) that are cholinergic. 7. has participated in any clinical investigational drug or device study within four weeks prior to study entry.
a long term follow-up of rotator cuff tear patients treated with integrated complementary and alternative medicine

Conditions: Rotator Cuff Tear

Summary: this study is a prospective observational trial. data of 4 hospitals will be used to find out the efficacy of conservative treatment in rotator cuff tear.

"rotator cuff tear is known as its symptoms which are pain, limited shoulder range of motion(rom), and the clicking sound of the shoulder. on recent research by health insurance review \& assessment service, the number of rotator cuff tear patients has increased from 508155 to 704838 during 2013-2017. and also the research reported that the difference of effect between surgical treatments and non-surgical treatments was unremarkable. so in most cases, non-surgical treatments are applied primarily on rotator cuff tear except for some serious cases. physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of rotator cuff tear by using korean medicine treatment so far has its weak level. therefore, it is expected that this study will demonstrate the efficacy of the treatment of rotator cuff tear in korean medicine treatment and will further pave the way for non-surgical treatment of rotator cuff tear. therefore, the investigators conducted an observational trial to analyze the effectiveness of korean medicine treatment in rotator cuff tear. retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. based on this, investigators will conduct research in the form of a prospective survey and analyze the causal relationship and factors using the two data. the hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through a questionnaire. the questionnaire will be developed after consultation with experts from the musculoskeletal system and related societies, and will be used for the questionnaire."

Eligibility criteria:
inclusion criteria: * patients who had been hospitalized with symptoms of shoulder pain at haeundae jaseng korean medicine hospital, jaseng korean medicine hospital, bucheon jaseng korean medicine hospital and daejeon jaseng korean medicine hospital from jan 2015 to mar 2020. * patients diagnosed with 'rotation cuff tear' finding of the emr imaging (t2-weighted mri scan of shoulder * patients who had been hospitalized more than 3 days * patients who are within age from 19 to 70 exclusion criteria: * patients who are hospitalized by traffic accident * patients who are diagnosed other serious shoulder injury that can cause shoulder pain(tumor of shoulder, acute fracture and dislocation of shoulder) * patients who had treated shoulder pain at haeundae jaseng korean medicine hospital, jaseng korean medicine hospital, bucheon jaseng korean medicine hospital and daejeon jaseng korean medicine hospital in recent 6 months. * patients who are considered impossible to attend survey by investigators.

Keywords: rotator cuff tear, korean medical treatment
evaluation of the long- term effects of spiriva on lung function in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this trial is to determine whether daily treatment with tiotropium (spiriva®, bromuro de tiotropio®) inhalation capsule via handihaler® reduces the rate of decline in lung function over time in patients with copd.


Eligibility criteria:
inclusion criteria: * written informed consent. * male or female patients 40 years of age or older. * smoking history of at least 10 pack years. * diagnosis of copd with post bronchodilator fev1 less than or equal to 70% of predicted normal and fev1\<70% of fvc and on stable respiratory medication. exclusion criteria: * significant diseases other than copd which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate. * myocardial infarction in past 6 months. * unstable or life threatening arrhythmia in past year. * hospitalization for nyha heart failure class iii or iv in past year. * active tuberculosis. * asthma. * pulmonary resection. * malignancy treated with radiation or chemotherapy in past 5 years. * respiratory infection in 4 weeks prior to screening. * known hypersensitivity to anticholinergic drugs or components. * known moderate to severe renal impairment. * known narrow angle glaucoma. * significant symptomatic bph or bladder neck obstruction. * need for oxygen therapy \>12 hr/day. * use of oral corticosteroids at unstable doses or \>10 mg/day.
study to learn more about the safety of drug jivi over a long period of time in previously treated patients with hemophilia a (bleeding disorder resulting from a lack of fviii) who are receiving jivi regularly at their treating doctors to prevent bleeding

Conditions: Hemophilia A

Summary: in this observational study researchers want to learn more about the safety of drug jivi over a long period of time. jivi (generic name: damoctocog alfa pegol) is an approved blood clotting factor viii (fviii) medication for the treatment of hemophilia a (bleeding disorder resulting from a lack of fviii). it is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other fviii products. therefore jivi acts longer in the body which reduces the frequency of drug injections. this study will enroll previously treated patients with hemophilia a who are receiving jivi regularly at their treating doctors to prevent bleeding. observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.


Eligibility criteria:
inclusion criteria: * signed informed consent/assent will be obtained before any study-related activities * ptps with hemophilia a assigned to jivi prophylaxis treatment * negative fviii inhibitor test before study entry * decision to initiate treatment with commercially available jivi has been made by the treating physician before and independently from the decision to include the patient in this study exclusion criteria: * known or suspected contraindications to jivi or related products * mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation * participation in an investigational program with interventions outside of routine clinical practice
glossopharyngeal nerve blockade for awake videolaryngoscope assisted endotracheal intubation in the morbidly obese

Conditions: Gagging

Summary: the investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese.


Eligibility criteria:
inclusion criteria: * morbid obese patients scheduled for bariatric surgery, with a planned awake intubation. exclusion criteria: * inability to communicate in english or french * allergies to any study drugs * any patient with an american society of anesthesiologists score of 4 or more
a study to assess the safety and efficacy of oral armour thyroid compared to synthetic t4 for the treatment of primary hypothyroidism in adult participants

Conditions: Hypothyroidism

Summary: this study will evaluate the efficacy and safety of armour thyroid treatment compared with synthetic t4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[tsh\]) on synthetic t4 treatment. this study will also therefore evaluate the efficacy and safety of dose conversion from synthetic t4 therapy to armour thyroid therapy.


Eligibility criteria:
inclusion criteria: * have a diagnosis of primary hypothyroidism made \>= 12 months prior to screening. * be on continuous thyroid replacement therapy of synthetic t4 for primary hypothyroidism for at least 12 months immediately prior to the screening visit. * be on a stable fda-approved daily dose of synthetic t4 prior to the screening visit, and must be taking synthetic t4 dose of at least 25 mcg at screening visit. must enter the study using the same stable dose to determine dose conversion. * documentation of 1 in-range thyroid-stimulating hormone (tsh) (i.e., within 0.45 - 4.12 miu/l, inclusive) at screening and at least 1 additional in range tsh (i.e., within 0.45 - 4.12 miu/l, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to screening. exclusion criteria: * any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of armour thyroid or synthetic t4. * history of alcohol or other substance abuse within the previous 6 months prior to the screening. * known or suspected allergy or intolerance to any ingredients of armour thyroid, including its excipients, synthetic t4, other thyroid replacement medications, or pork products.

Keywords: hypothyroidism armour thyroid synthetic t4
adi-peg20, obesity and prediabetes

Conditions: Obesity; PreDiabetes

Summary: th purpose of this study is to determine whether adi-peg20 (pegylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.

obesity, insulin resistance, and their complications are major causes of morbidity and mortality in children, adolescents, and adults. although caloric restriction is an effective treatment, intensive lifestyle changes are rarely durable. the investigators and others have shown that: (i.) fasting incites arginine catabolism, and forced arginine catabolism recapitulates several therapeutic effects of fasting, (ii.) exogenous, forced arginine catabolism improves metabolic health, and (iii.) adi-peg20 (pegylated arginine deiminase) is an arginine catabolizing enzyme preparation that improves insulin sensitivity, mitochondrial respiration, and energy utilization in obese mice. the study will determine whether adi-peg20 also exerts beneficial effects on metabolic healthy in people. the investigators will perform a 12-week, randomized, double-blind, placebo-controlled trial in boys and girls with pre-diabetes to evaluate the efficacy of adi-peg20 treatment on: 1) body composition; 2) resting energy expenditure; 3) multi-organ insulin sensitivity; 3) β-cell function; and 4) muscle mitochondrial function.

Eligibility criteria:
inclusion criteria: * age: ≥18 and ≤22 years; * bmi 25.0 - 44.9 kg/m2; * prediabetes, defined as fasting plasma glucose of ≥100 mg/dl, or hba1c ≥5.7%, or homa-ir ≥2.5. exclusion criteria: * hba1c ≥6.5%; * intolerance or allergies to ingredients in adi-peg20 or placebo; * taking dietary supplements or medications known to affect our study outcomes; * evidence of significant organ system dysfunction or diseases, * metallic implants, which would preclude mri
recombinant vaccinia virus administered intravenously in patients with metastatic, refractory colorectal carcinoma

Conditions: Colorectal Carcinoma; CRC

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of jx-594 (pexa-vec) administered intravenously either alone or in combination with irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.

this was a phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (crc)

Eligibility criteria:
inclusion criteria: * histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator * failed treatment with irinotecan * kras mutant tumor or kras wild-type having failed cetuximab (erbitux) or panitumumab (vectibix) or had contradictions to treatment * regorafenib-naïve (have not received regorafenib) * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 * measurable tumor (≥1 cm longest diameter) * acceptable health status as determined by the investigator and blood work (chemistry, complete blood count, coagulation) exclusion criteria: * intolerant to irinotecan (if assigned to the combination arm: cohort 3, cohort 4 or combination expansion arm) * treatment with ketoconazole, enzyme-inducing anticonvulsants and st. john's wort (if assigned to combination arm) * significant immunodeficiency due to underlying illness and/or medication * history of severe exfoliative skin condition requiring systemic therapy within the past 2 years * clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions * active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months * viable centrual nervous system (cns) malignancy associated with clinical symptoms * received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas) * prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment * use of prohibited anti-viral medication, interferon/pegylated interferon (peg-ifn) or ribavirin that cannot be discontinued within 14 days prior to any jx 594 dose * inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all jx-594 treatments. * pregnant or nursing an infant * diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.

Keywords: vaccinia vaccinia virus jx-594 jennerex colorectal carcinoma colorectal cancer colon cancer rectal cancer oncolytic virus viral therapy ras mutant erbitux failure oxaliplatin failure folfox failure folfiri failure irinotecan failure pexa-vec
using facebook to support opioid recovery among american indian women

Conditions: Opioid Use Disorder

Summary: the purpose of this study is to find out whether a facebook group will help native women in recovery from opioid use.


Eligibility criteria:
inclusion criteria: 1. aian person based on self-reported race/ethnicity 2. gender identity as a woman 3. at least 18 years of age with no upper age limit 4. resides in minnesota 5. meets criteria for oud based on the dsm-5 checklist (american psychiatric association, 2013) 6. self-reports at least one month of abstinence from opioid use based on tlfb interview and negative urine opiate screen 7. current use of moud 8. is comfortable speaking and reading english 9. has an existing facebook account or willing to set one up 10. is willing and able to participate in the facebook intervention for 3 months 11. has access to broadband internet on a mobile phone/computer/tablet at any location 12. is willing and able to travel to a community clinic in minneapolis, minnesota for the uds or is willing to and able to complete a virtual zoom uds visit. 13. provides written informed consent exclusion criteria: 1. self-reports current suicidality based on the concise heath risk tracking scale 2. participated in prior study phases (aim 1 formative work) of nida ctn-0123

Keywords: american indian or alaska native internet-based intervention community-based participatory research minnesota ethnic and racial minorities women's health
breathe-easy: food supplement for respiratory health

Conditions: Respiration Disorders; Chronic Respiratory Conditions; Pulmonary Diseases or Conditions; Chronic Disease Management; Respiratory Tract Disorders

Summary: the trial aims to assess the effectiveness of a natural lung care solution and a food supplement in improving lung function, capacity, and alleviating symptoms associated with respiratory conditions like asthma, copd, and chronic bronchitis.


Eligibility criteria:
inclusion criteria: * adults aged 18 and older. * diagnosed with a chronic respiratory condition (e.g., asthma, copd). * no known allergies to ingredients in the supplement. * ability to provide informed consent and comply with study procedures. exclusion criteria: * acute respiratory infection within the last 30 days. * current participation in another clinical trial. * history of severe adverse reactions to similar supplements.

Keywords: lung care breathe-easy dietary supplement
pharmacokinetics of adalimumab with methotrexate for treatment of patients with ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: assess the body's reaction to dose-response relationship for the adalimumab/methotrexate interaction in subjects with moderately to severely active ulcerative colitis.

assess the pharmacokinetic dose-response relationship for the adalimumab/methotrexate interaction in subjects with moderately to severely active uc.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating females. females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]). * diagnosis of uc confirmed by established criteria, regardless of disease duration. * moderate to severely active uc, defined by a modified mayo score ≥6, with confirmed endoscopic activity by central reader (mayo endoscopic subscore ≥2). * require initiation with adalimumab for induction of remission. * ability of subject to swallow study drug capsules. * ability of subject to participate fully in all aspects of this clinical trial. * written informed consent must be obtained and documented. exclusion criteria: * prior treatment with a tnf antagonist or biological therapy. * prior treatment with mtx. * disease limited to the rectum (proctitis). * documented presence of antibodies against adalimumab. * contraindication for anti-tnf or mtx therapy. * contraindication for endoscopy. * ostomy. * planned surgery.

Keywords: moderately to severely active ulcerative colitis
correlation between mrs (magnetic resonance spectroscopy) and tumor response to radiation therapy in breast cancer

Conditions: Breast Cancer

Summary: correlation between mrs and tumor response therapy in breast cancer.

correlation between mrs (magnetic resonance spectroscopy and tumor response to radiation in breast cancer

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosed breast cancer * patient is 18 years or older * karnofsky performance score \> 70 * no previously irradiated or recurrent breast cancer * no contraindication to mrs/mri * signed informed consent.

Keywords: cancer mrs treatment response