Kornimate/medical-research-clean huggingface dataset:
the influence of different anesthesia on acute and chronic postsurgical pain after thoracic surgery

Conditions: Acute Pain; Chronic Postsurgical Pain

Summary: this study would compare acute and chronic postsurgical pain in patients underwent thoracic surgery with different anesthesia and analgesia methods, and explore the influencing factors.

chronic postsurgical pain (cpsp) was the pain caused by the operation that exceeded the healing time of normal tissue (usually 3 months), that was, a status that the damage caused by noxious stimulus had been healed, but the pain that cannot be explained by disease and inflammation were still existed. due to the location of the incision and the necessity of indwelling the chest tube, the thoracic lung surgery was considered to be one of the most painful surgical operations. studies have found that the incidences of cpsp in patients with thoracotomy were 57% (95% ci, 51-64%) and 47% (95% ci, 39-56%) at postoperative 3 and 6 months, respectively. with the development of minimally invasive techniques, thoracic surgery had gradually become less traumatic, and the number of surgical incisions was gradually developed into single port.through ages, epidural analgesia with a combination of local anesthetics and opioids had long been considered the "gold standard" for postoperative analgesia in thoracic surgery. however, with the development of clinical anesthetics and the widespread use of nerve block techniques, it had been found that in open radical gastrectomy, there was no significant difference in the inhibition of intraoperative stress response between dexmedetomidine combined with general anesthesia and a combined general-epidural anesthesia. so, which anesthesia and analgesia method was "perfect" for a specific type of surgery procedure? this study would compare acute and chronic postsurgical pain in patients underwent different thoracic surgery procedure with different anesthesia and analgesia methods, and explore the influencing factors.

Eligibility criteria:
inclusion criteria: * asa i-ii * underwent selective thoracic surgery exclusion criteria: * with severe cardiac, endocrine,immunologic or haematologic diseases * medical history of chronic pain problems in chest area * medical history of pain-relief or sedative medication * not able to communicate with investigators
clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics

Conditions: Decubiti; Chronic Wounds; Acute Wounds

Summary: the study objective is to improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. currently, resistance testing will only be performed for the treatment with antibiotics.

complications like bacterial wound colonization and infections in wound treatment are still a serious problem. several therapy approaches are available to treat these complications, e.g. surgical wound debridement, antimicrobial therapy that can be divided into a local and a systemic antisepsis. the local antisepsis (the local utilization of antiseptics directly to the wound) is in many ways advantageous to the systemic antisepsis (orally or intravenously administered antibiotics): e. g. the direct contact of the antiseptic to the bacteria at the site of infection whereas antibiotics may not sufficiently reach the wound due to limited blood perfusion of wounds; growing utilization of systemic antisepsis also leads to an increasing number of resistant bacteria worldwide. to the concerns of many specialists, the first pan-resistant bacterial strain which is resistant to all available antibiotics including colistin was recently published. in future, the role of local antisepsis therefore becomes more important in the antimicrobial treatment. luckily, resistances of local antiseptics occur slowly due to the chemical and structural characteristics of antiseptics but even resistances of bacteria to antiseptics were reported. unlike the antimicrobial resistance testing for antibiotics that is done in the clinical routine, such testing is not a standard procedure for antiseptics for no obvious reason. the utilization of antiseptics is determined by the availability of products provided within the institution and preferences of the clinician. thus, it is unknown whether the chosen antiseptic has any bactericidal effect on the confirmed bacteria. university hospital rwth aachen wound care only uses polyhexanide and octenisept. iodine-containing preparations are explicitly not desired.improvement (bacteria reduction, acceleration of wound healing) of the local antiseptic therapy by adapting the antiseptic to the results of antimicrobial resistance testing. antimicrobial resistance testing has so far only been used to adapt systemic antibiotic therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. decubitus or secondary healing acute and chronic wounds 3. positively tested wound swab for bacteria (incl. multi-resistant bacteria) 4. patient is capable of understanding the nature, significance and consequence of the clinical trial 5. given written consent 6. women of child bearing potential (wocbp) who apply appropriate methods of contraception throughout the duration of the study exclusion criteria: 1. occlusive dressing (e.g. vac) or negative pressure wound therapy (npwt) 2. pregnant or lactating women 3. known allergies against investigational products
genistein in treatment of metastatic colorectal cancer

Conditions: Colon Cancer; Rectal Cancer; Colorectal Cancer

Summary: colorectal neoplasms are the third most common malignancies in the united states. patients with metastatic (stage iv) colorectal cancer have a median life expectancy of 2 years. the response rates to chemotherapy range from 35-40%. epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit wnt signaling, a pathway activated in majority of colorectal cancers. laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-fluorouracil and platinum compounds. based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. the aim of the study is to add genistein to the regimens of folfox or folfox-avastin in patients with newly diagnosed stage iv colon or rectal neoplasms.

objectives: primary * evaluate the tolerability of genistein when combined with chemotherapy secondary: * evaluate response rate (rr) as measured by the radiologic recist criteria * evaluate progression free survival (pfs)

Eligibility criteria:
inclusion criteria: * adult male and female patients ≥18 years old * have pathologically confirmed colon or rectal carcinoma * have metastatic (stage iv) disease * have a plan by treating physician to receive folfox or folfox-avastin * have an eastern cooperative oncology group (ecog) performance status ≤2 * have adequate hematopoietic, hepatic and renal function 1. hematopoietic function * hemoglobin ≥10g/dl * absolute neutrophil count(anc) ≥1,500cells/mm2 * platelet count ≥100,000/µl 2. hepatic function * total bilirubin ≤ 1.5x the upper limit of normal * alt and ast must each be ≤2,5x the upper limits of normal 3. renal function * estimated creatinine clearance (clcr) ≥30 ml/minute * are not pregnant and do not plan to become pregnant exclusion criteria: * prior systemic chemotherapy for metastatic disease * history of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators * patients taking mao-inhibitors * history of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study * unable to give informed consent or comply with clinical trial requirements * uncontrolled hypertension * history of clinically significant gi bleeding within prior 2 months prior to enrollment * presence of gi fistula * prior history of bowel perforation * history of cns thrombotic/embolic or ischemic events * have past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with the follow up visits.

Keywords: genistein soy supplements phytoestrogens colon cancer rectal cancer colorectal cancer metastatic stage iv folfox folfox-avastin chemotherapy
inspiratory muscle training in patients with covid-19

Conditions: Covid19; Respiratory Disease

Summary: covid 19 has become a pandemic and has led to high demand on healthcare systems. it can cause a severe acute respiratory syndrome (sars cov-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. objective: improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. method: prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. results: the findings will be compared before and after the approach and will be presented in graphs and tables. statistical tests will be used considering a significance level of 5%.

prospective clinical study in patients with covid-19 admitted to a non-critical unit of a tertiary hospital. they were randomized into a group that received motor and respiratory exercises and another group that received the same exercises associated with respiratory muscle training.

Eligibility criteria:
inclusion criteria: * patients diagnosed with covid-19 through pcr aged over 18 years admitted to non-critical units. exclusion criteria: * patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.

Keywords: physiotherapy exercises respiratory muscle training
epidemiology of chronic hepatitis c and disease modelling

Conditions: Hepatitis C

Summary: hepatitis c (hcv) is a major health problem amongst people who inject drugs (pwid) and have limited contact with health care services. halfway houses (hh) serve to reintegrate former drug users into society. strategies to eliminate hcv must focus on screening for hcv amongst hh. linkage to care for pwid population is an issue globally. the aim is to determine the sero-prevalence, demographics, disease distribution and factors associated with the risk of hcv transmission amongst former drug users at halfway houses. the secondary aim would be to determine the best models of care that can be used to link these individuals to existing healthcare services in a pragmatic, randomised fashion halfway houses are invited to participate in a program of hcv education, point-of-care screening using oraquick test and staging with fibroscan® by a small mobile team of healthcare workers. a detailed survey regarding illicit drug injecting practices is performed. those who are tested positive are referred to medical care. it is anticipated that the prevalence of hepatitis c within the drug injecting population along with the stages of liver disease such that models for disease burden can be determined.

this is a pragmatic observational study of point of care hcv screening in the halfway house resident /pwid population. in the secondary aim the hcv positive subjects are randomised to traditional referral pathway (hcv positive cases attend primary care facilities to get referral to specialist clinic in hospital) and 'direct' open access where the hcv positive cases has direct open access to specialist clinic as above (by passing primary care physicians). we observe the no. of subjects being linkage to specialist care, and hcv treatment

Eligibility criteria:
inclusion criteria: * former drug users residing in halfway houses exclusion criteria: * age below 21 years * residents of halfway houses who have never used drugs

Keywords: community screening halfway house people who inject drugs substance users released prisoners
adebrelimab with or without shr-8068 in combination with cisplatin plus gemcitabine as first-line treatment in patients with advanced biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: this study aims to evaluate the efficacy and safety of shr-8068 and adebrelimab in combination with cisplatin plus gemcitabine(cisgem), compared with adebrelimab in combination with cisgem, as first-line treatment in patients with advanced biliary tract cancer.


Eligibility criteria:
inclusion criteria: 1. age 18\~75 years old, both male and female; 2. histologically or cytologically confirmed unresectable locally advanced, or recurrent/metastatic biliary tract adenocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma); 3. has not received prior systemic anti-tumor therapy; 4. at least one measurable lesion based on recist v1.1 criteria; 5. ecog ps score: 0-1 points; 6. expected survival period ≥ 3 months; 7. adequate organ function; 8. must take one medically approved contraceptive measure; 9. patients voluntarily joined the study and signed informed consent. exclusion criteria: 1. history or concurrently has other solid tumor; 2. patients with liver tumor burden greater than 50% of total liver volume; 3. history of previous hepatic encephalopathy; 4. patients with biliary obstruction ， at risk of biliary tract infection; 5. patients with undergone major surgical treatment within 4 weeks before randomization; 6. patients with any active, known or suspected autoimmune disorder; 7. patients with active pulmonary tuberculosis; 8. patients with known history of hiv or active hepatitis; 9. untreated central nervous system metastasis; 10. pleural or peritoneal effusion with clinical symptoms; 11. patients with poorly controlled cardiac clinical symptoms or disease; 12. patients with abnormal coagulation function and bleeding tendency; 13. known allergic reaction to adalimumab or other monoclonal antibodies, or to the trial drug; 14. patients with other potential factors that may affect the study results.
diclofenac patch for the treatment of acute pain due to mild to moderate wrist sprain, strain or contusion

Conditions: Acute Pain

Summary: the purpose of the study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain, strain or contusion when applied to the painful area.

this randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion. eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. patients will return to the clinic for assessments on day 3 and day 7; a follow-up assessment will be conducted on day 14. patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility criteria:
inclusion criteria: * male and female subjects 17 - 75 years of age * sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion * meet baseline pain criterion exclusion criteria: * open wound or infection at the site of injury * severe wrist injury or wrist fracture * presence or history of hand, wrist or forearm nerve impingement or palsies * use of nsaids or opioids within 12 - 24 hours of wrist injury * presence or history of peptic ulcers or gi bleeding * history of intolerance to nsaids, acetaminophen, adhesives * positive pregnancy test * positive drug screen

Keywords: wrist sprain strain contusion diclofenac patch acute pain acute pain due to mild to moderate wrist sprain, strain or contusion
extended-release guanfacine hydrochloride in children/adolescents with attention-deficit/hyperactivity

Conditions: Attention Deficit Disorder

Summary: a study to evaluate the long term maintenance of efficacy of using guanfacine hydrochloride (spd-503) for the treatment of adhd in children aged 6-17 years in europe, australia, canada and the us.

the spd503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of adhd in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. this study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. to date, all of the completed studies conducted as part of the spd503 proigram have enrolled subjects from the us. this study is designed to evaluate the long-term maintenance of efficacy of spd503 for the treatment of adhd in children aged 6-17 years in europe, australia, canada and us.

Eligibility criteria:
inclusion criteria: * male or female, aged 6-17 years at the time of consent/assent at screening/visit 1 * subject meets dsm-iv-tr criteria for primaru diagnosis of adhd * subject has a minimum adhd-rs-iv total score of 32 at enrolment/visit 2 * subject has a minimum cgi-s score of 4 at enrolment/visit 2 * subject is able to swallow intact tablets exclusion criteria: * subject has a current controlled or uncontrolled, co-morbid psychiatric diagnosis. * subject has a know history or presence of structural cardiac abnormalities * subject with orthostatic hyupotension or a known history of controlled or uncontrolled hypertension * current use of any prohibited medication or other medications, including herbal supplements that affet blood pressure, or heart rate or that have cns effects or affect cognitive performance * subject is significant overweight based on centre for disease control and prevention bmi for age gender specific charts. significantly overweight is defined as a bmi \>95 th percentile children aged 6-12 years with a body weight ,25,0kg, or adolescents aged 13-17 years with a body weight \ 91 kg at screening/visit 1 * subject is currently considered a suicide risk in the opinion of the investigator * history of failure to respond to an adequate trial of an alfa2-agonist for the treatment of adhd.
characterization of corneal epithelial changes in participants treated with belantamab mafodotin

Conditions: Multiple Myeloma

Summary: this study will be available to any participant who has received or is currently receiving belantamab mafodotin treatment through either a clinical trial, an access program, or a physician prescription. participants do not need to be on active treatment. the purpose of this study is to gain a more complete understanding of the pathophysiology of the corneal events seen in some participants with relapsed/refractory multiple myeloma (rrmm) treated with belantamab mafodotin. a superficial corneal epithelial tissue specimen will be obtained by performing impression cytology (ic) or superficial keratectomy (sk) procedure in participants treated with belantamab mafodotin. the procedure will only be performed in one eye, most affected by the corneal epithelial changes. this specimen will undergo pathologic examination and composition analysis.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 years or older (at the time consent is obtained). * capable of providing signed written informed consent, which includes compliance with the requirements and restrictions listed on the consent form. * participants with rrmm who have received or are currently receiving treatment with belantamab mafodotin and diagnosed with microcyst-like epithelial changes (mecs) on slit-lamp examination or confocal microscopy, with or without symptoms, in at least one eye. a) if participants only had superficial punctate keratopathy with no evidence of mec's they are not eligible. * if undergoing sk procedure, treating provider has determined there is no excessive risk to the participant. exclusion criteria: * any serious and or/unstable medical or psychiatric disorder, or other conditions that could interfere with the participant's safety. * any excess risk of delayed wound healing (for example, diabetes mellitus). * do not meet criteria specified by the study or program through which they would receive belantamab mafodotin. * any participant taking concurrent medication that may affect the cornea (that is. amiodarone, some chloroquines). * any participant with decreased corneal sensation. * eye infections, including infectious keratopathy, stye, blepharitis, and conjunctivitis. * an active uveitis including anterior, posterior, or panuveitis in either eye. * permanent legal blindness in the fellow (non-study) eye.

Keywords: belantamab mafodotin impression cytology superficial keratectomy relapsed/refractory multiple myeloma
a study to investigate the efficacy and safety of brepocitinib in adults with dermatomyositis

Conditions: Dermatomyositis

Summary: this is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (tyk2/jak1 inhibitor) in adults with dermatomyositis (dm). the primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the total improvement score (tis). after 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.


Eligibility criteria:
inclusion criteria: * a diagnosis of dermatomyositis according to 2017 eular/acr classification criteria for idiopathic inflammatory myopathies * adult subjects (18-75 years old) * active muscle and skin disease at screening and baseline * prior therapy or current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant * weight \> 40 kg to \< 130 kg, and with a body mass index (bmi) \< 40 kg/m2. exclusion criteria: * dermatomyositis with end-stage organ involvement * dermatomyositis with irreversible muscle involvement * history of: * any lymphoproliferative disorder * active malignancy; * history of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) * cancer-associated dermatomyositis * overlap myositis/connective tissue disease (except for overlap with sjögren's syndrome) * participants at a risk of thrombosis or cardiovascular disease * participants with a high risk for herpes zoster reactivation * participants with active or recent infections

Keywords: brepocitinib dermatomyositis tyk2/jak1 inhibitor pf-06700841 pvt-2201