Kornimate/medical-research-clean huggingface dataset:
diclofenac patch for treatment of acute pain due to mild to moderate soft tissue injuries (taped)

Conditions: Acute Pain; Soft Tissue Injury

Summary: the primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.

this randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries. eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 14 days. patients will return to the clinic for assessments on day 3, day 7 and day 14; a follow-up assessment will be conducted on day 21. patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. functional disability and global impression of change will be recorded in the diary at study visits, ratings of the quality of sleep will 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 18-75 years of age * sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle) * meet baseline pain criterion exclusion criteria: * open wound or infection at site of injury * evidence of severe injury, including fracture or nerve injury * use of oral nsaids or opioids within 12-24 hours of injury * presence or history of peptic ulcers or gi bleeding * a history of intolerance to nsaids, acetaminophen, adhesives * positive pregnancy test * positive drug screen

Keywords: diclofenac acute pain topical patch acute pain due to mild to moderate soft tissue injury
a study of gemcitabine-cisplatin chemotherapy plus necitumumab in the first-line treatment of participants with squamous lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. the study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. the study will last approximately 2 years.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed squamous non-small cell lung cancer (nsclc) * stage iv disease at time of study entry based on american joint committee on cancer 7th edition * measurable disease at time of study entry as defined by response evaluation criteria in solid tumors (recist), version 1.1 * required to have a performance status (ps) 0-1 exclusion criteria: * nonsquamous nsclc * prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (egfr), vascular endothelial growth factor (vegf), or vegf receptor * previous chemotherapy for nsclc * major surgery or received any investigational therapy in the 4 weeks prior to study enrollment * chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) * brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
universal chimeric antigen receptor t-cell （ucar t-cell） therapy targeting cd19/b cell maturation antigen （cd19/bcma） in patients with r/r neurological autoimmune diseases

Conditions: Neuromyelitis Optica Spectrum Disorders; Myasthenia Gravis; Multiple Sclerosis; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Autoimmune Encephalitis

Summary: this is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory neurological autoimmune diseases. this study aims to evaluate the safety and efficacy of the treatment with universal cd19/bcma car t-cells.

this is an investigator-initiated trial to evaluate the safety and efficacy of universal cd19/bcma car t-cells in relapsed or refractory neurological autoimmune diseases. study intervention consists of a single infusion of universal car t-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. interim analysis will be performed when participants finish the visit 90 days after car t-cell infusion.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * flow cytometry detected positive b cell cd19 or bcma in the patient's peripheral blood. * subjects with relapsed or refractory neurological autoimmune diseases, including neuromyelitis optica spectrum disorders(nmosd), myasthenia gravis(mg), multiple sclerosis(ms)，autoimmune encephalitis(ae) and chronic inflammatory demyelinating polyradiculoneuropathy(cidp). * female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; female subjects of childbearing potential must have a negative human chorionic gonadotropin (hcg) test within 7 days before study enrollment and not be lactating. * willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. exclusion criteria: * subjects with a history of severe drug allergies or allergic tendencies. * history of malignancy within five years. * subjects with insufficient cardiac function. * subjects who are positive for hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab) with peripheral blood hbv dna \>the upper limit of detection; subjects positive for hepatitis c virus (hcv) antibody and peripheral blood hcv rna; individuals positive for human immunodeficiency virus (hiv) antibody; individuals positive for syphilis testing. * pregnant women or women planning to conceive.

Keywords: universal allogeneic car t-cells
impact of mesh fixation with tissue adhesive

Conditions: Groin Hernia; Hernia, Inguinal; Postoperative Pain; Neuropathic Pain

Summary: randomized controlled trial on mesh fixation using cyanoacrylate glue compared to standard suture in open inguinal hernia repair.

hernioplasty with suture-fixed mesh is the standard technique for the treatment of inguinal hernia, one of the most frequent pathologies in the surgery service. despite its good results in terms of recurrences, it is currently under review due to the incidence of chronic postoperative pain. up to half of the patients report some type of pain at one year of follow-up, and 15% report moderate-severe pain. the objective of the study is to analyze whether the use of tissue adhesive (n-hexyl cyanoacrylate 0.5 ml) for mesh fixation in patients undergoing scheduled open inguinal hernioplasty results in a better postoperative evolution, with less chronic pain and less demand for analgesia, compared with a control group of patients who undergo the same surgical intervention with standard suture repair.

Eligibility criteria:
inclusion criteria: * elective open inguinal hernioplasty in patients over 18 years old exclusion criteria: * patient refusal * laparoscopic surgery * reintervention surgery * urgent surgery * cyanoacrylate allergy * administration of intraoperative local anesthetics * comorbidities that may affect the requirements of analgesics, such as degenerative arthropathies, fibromyalgia, etc.

Keywords: hernioplasty mesh fixation n-hexyl cyanoacrylate groin hernia postoperative pain
study to assess renewal of treatment in patients recently diagnosed with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to collect some parameters which may help to provide guidance on how androgen deprivation therapy (adt) drugs are renewed and physician satisfaction.


Eligibility criteria:
inclusion criteria: * adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month gnrh analogue triptorelin formulation * expected survival \> 12 months. * patients having provided written informed consent. * patients mentally fit for completing a questionnaire. exclusion criteria: * treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study. * patients who already have been treated with a gnrh analogue within the last year. * patients with hypersensitivity to gnrh, gnrh analogue, triptorelin or its excipients. * patients with a contraindication according to smpc.
dairy lipids and cardiometabolic risk

Conditions: Morbid Obesity

Summary: it is a randomized parallel arm intervention study in adults with severe obesity. the objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein b concentrations than the daily ingestion of low-fat dairy products (control group). metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.


Eligibility criteria:
inclusion criteria: * men and women between 18-70 years * body mass index (bmi) between 35 and 60 kg/m2 inclusive * stable body weight (weight change +/- 5 % for 3 months prior to screening) * consumption of at least 1 serving/day of dairy products made from cow's milk * informed consent exclusion criteria: * history of bariatric or digestive surgery or disease interfering with main outcomes * drinking more than 3 glasses of alcohol per day (\>30g/day) * pregnancy, parturiency or breastfeeding * food allergies or intolerance to dairy products * dietary restriction (vegetarian or lactovegetarian) or high protein diet * use of dietary supplements * treated with lipid lowering drugs (fibrates, statins, anti-pcsk9, ezetimibe, cholestyramine) within the last 6 weeks before study entry * treated with insulin, glp-1 analogs, acarbose, corticoids, beta-blockers. * medications interfering with intestinal microbiota (beta-lactamines within 3 months before the study or laxatives) * smoking ≥ 5 cigarettes/day during the past 6 months.

Keywords: obesity nutrition dietary intervention weight loss metabolism dairy fat milk polar lipids
icotinib with concurrent radiotherapy vs. chemoradiotherapy in non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the current standard of care for unresectable locally advanced non-small-cell lung cancer (nsclc) is a combination of chemotherapy and thoracic radiotherapy (trt). the standard regimens consist of platinum-based doublet chemotherapy.icotinib(bpi-2009, conmana) is the first self-developed small molecular drug in china for targeted therapy of lung cancer.icotinib is a novel oral quinazoline compound that has proven survival benefit in chinese patients with lung cancer,especially in egfr mutation lung cancer. this randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus pemetrexed + carboplatin with concurrent radiotherapy in inoperable stage iii non-small cell lung cancer with egfr mutation, the primary endpoint is progression-free survival.


Eligibility criteria:
inclusion criteria: 1. unresectable stage iiia / iiib non-small cell lung cancer with egfr 19/21 mutation. 2. no previous systemic anticancer therapy. 3. life expectancy more than three months. 4. ecog performance status of 0 to 1. 5. measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site. 6. patients will be required to provide informed consent before enrollment. exclusion criteria: 1. intrapulmonary metastasis, atelectasis of an entire hemithorax,pleural dissemination, or contralateral hilar lymph node metastasis. 2. prior chemotherapy for nsclc, chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway. 3. severe heart disease, uncontrolled diabetes mellitus, or active infection. 4. active concomitant malignancy, and pregnancy or breast-feeding.

Keywords: inoperable stage iii non-small cell lung cancer egfr mutation icotinib radiotherapy chemoradiotherapy
safety and efficacy of ginsenoside rg3 in combination with first-line chemotherapy in advanced gastric cancer

Conditions: Self Efficacy

Summary: safety and efficacy of ginsenoside rg3 in combination with first-line chemotherapy in advanced gastric cancer.the purpose of this study is to assess the safety of ginsenoside rg3 in advanced gastric cancer, and whether it improves the efficacy of first-line chemotherapy.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. performance status- eastern cooperative oncology group (ecog) 0-1; 3. histologically or cytologically confirmed gastric cancer; 4. at least have one measurable disease(according to recist, response evaluation criteria in solid tumors ) 5. life expectancy of at least 3 months; exclusion criteria: 1. received any prior treatment including ginsenoside rg3; 2. active or uncontrolled infection; 3. concurrent treatment with an investigational agent or participation in another therapeutic clinical trial; 4. pregnant or lactating women.
comparison of erector spinae plane block and rectus sheath block

Conditions: Postoperative Pain, Acute

Summary: in study, the investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.

following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in american society of anesthesiologists (asa) classes i-iii, who were to undergo midline incisions. the demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the espb group and rsb group. hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. patient-controlled analgesia (pca) prepared with morphine was administered to all patients. patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (vas) at rest and during coughing, time to first pca dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.

Eligibility criteria:
inclusion criteria: * aged 18-75 years * american society of anesthesiologists (asa) classes i-iii exclusion criteria: * local anesthetic allergy * coagulopathy * injection site infection * history of abdominal surgery * severe neurological or psychiatric disorder * severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate \<15 ml/min/1.73 m2) * chronic opioid use

Keywords: erector spinae plane block rectus sheath block pain management midline laparotomy
effects of humidity (during cpap treatment) on mucociliary clearance in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: that the level of humidification delivered to patients during cpap treatment will alter the subjects mucociliary clearance rate and related mucus properties.


Eligibility criteria:
inclusion criteria: * moderate to severe obstructive sleep apnea - apnea hypopnea index (ahi) \> 15 * 75% of events during the diagnostic study must be obstructive exclusion criteria: * currently using cpap treatment or have used it in the past 4 weeks * intolerance of cpap and/or cpap mask in the past or during the titration night * mouth breather (unable to breath through mouth for the study period) * \< 18years old * nasal cpap intolerance determined in the psg-cpap titration study * serious nasal issues * acute upper airway disease * smoker * copd * congestive heart failure * neuromuscular disease * stroke
pediatric solid tumor metabolism [a prospective study exploring metabolism of solid tumors in pediatrics]

Conditions: Neuroblastoma; Sarcoma; Pediatric Cancer

Summary: to explore metabolic phenotypes of children with extra-cranial solid tumors and compare these with their histopathological and genetic alterations to discover potential novel biomarkers and therapeutic targets to improve outcomes in children with high risk disease.

the principal objective of this study is the metabolic characterization of pediatric solid tumors, with a particular focus on neuroblastoma (nbl) and fusion positive sarcoma (fps), which will allow the detection of tumor specific metabolic alterations that can be exploited with the aim of developing novel therapeutic strategies and biomarkers. cellular metabolism studies provide insight, in a complementary way to genomics, into processes acting downstream from oncogenes and oncogenic fusion proteins, and such insight may point toward previously unrecognized therapeutic targets or onco-metabolites that are traceable as robust biomarkers for response. the investigator's new approach to use an in-vivo comprehensive analysis of metabolic reprograming in fps/nbl has never been performed in childhood fps/nbl and will complement genomics studies for these cancers. for this study, the investigators plan to obtain tumor samples at time of surgical biopsy/resection and study their metabolic signatures.

Eligibility criteria:
inclusion criteria: * suspected malignancy * age ≤ 26 years and being cared for at children's medical center * ability to undergo standard of care diagnostic procedure, including biopsy or resection of the tumor, in the or or ir at cmc exclusion criteria: * poorly controlled diabetes * any other medical condition that prevents administration of glucose
treatment of adenocarcinoma of the rectum with transanal local excision for complete responders

Conditions: Rectal Cancer

Summary: the current standard of care for rectal cancer has diminished local recurrence and enhanced survival. quality of life, however, remains poor for many patients and the probability of distant recurrence is high. in this study, we will attempt to reduce the distant recurrence rate and improve quality of life by making changes in the timing and administration of chemotherapy and radiation and doing less invasive rectal surgery when indicated.

the purpose of the study is to determine if neo-adjuvant folfox therapy and lengthening the time interval between neo-adjuvant chemotherapy and transanal local excision will increase the percentage of patients with pathologic complete remission. this is a prospective pilot study to examine the impact of two variables: 1) addition of neo-adjuvant folfox chemotherapy, and 2) increasing the time interval between completion of chemo-radiotherapy and subsequent surgery, on the rate of achieving pathologic complete remission with avoidance of radical resection while maintaining an excellent local control with improvement of quality of life. all procedures in this study are standard of care, the study question relates to the use of neo-adjuvant folfox and the timing between the end of radiation and surgery.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. diagnosis of rectal invasive adenocarcinoma 3. tumor in the low or mid rectum (up to 11 cm from the anal verge) 4. clinical stage t3/n0-n1m0. patients with low t2 who will need abdominal perineal resection are also eligible. 1. clinical staging will be estimated based on the combination of the following assessments: 1. physical examination by the primary surgeon 2. computed tomography or positron emission tomography/computed tomography scan of chest, abdomen and pelvis 3. pelvic mri and endoscopic ultrasound exclusion criteria: * less than 18 years of age * do not complete informed consent * pregnant women
role of the oral microbiome & mucosal immunity in covid-19 disease

Conditions: COVID-19; Microbial Colonization; Oral Disease; Periodontal Diseases; Innate Inflammatory Response; Mucosal Infection

Summary: determining whether in the mouth there are differences between the participant groups in the nature and activity of mucosal innate immunity, in immune responses to sars-cov2 antigens, or in the oral microbiome

cross sectional with longitudinal component * stimulated whole mouth fluid (swmf) and blood samples from south asian and non-asian populations * controls, and covid-19 patients in both populations. * oral disease questionnaire and clinical examination * separation of swmf into pellet for dna extraction for microbiomics and supernatant for cell phenotype analysis, cytokines and antibodies to sars-cov2 antigens

Eligibility criteria:
inclusion criteria: * • south asian and white british persons and those diagnosed with symptomatic or asymptomatic covid-19 infection. * aged 18 or over. able to understand and consent. * uninfected subjects: no history of covid-19; not vaccinated; (negative for anti-sars-cov2 nucleoprotein antibodies at lab) * for patient groups: confirmed covid-19 positivity, symptoms and symptom onset within the past 21 days; be recently hospitalised with covid-19 disease; have covid-19 disease proven by pcr testing for sars-cov-2 within the last 21 days; covid disease severity graded as per nih/who. * recovered groups: have had covid-19 disease proven by pcr testing for sars-cov-2. covid disease severity graded as per who or nih equivalent criteria * those willing to participate on a single occasion but unwilling to participate with longitudinal samples will not be excluded. * smoking, obesity, diabetes, heart disease, antibiotics or treatment related to covid is not excluded. exclusion criteria: * • those patients unwilling to participate, those unable to understand sufficiently to give informed consent and those unable to participate due to the severity of covid-19 disease. those patients classified as not either south asian or white british heritage. * patients with malignancy, pregnancy, long term immune suppression, inability to give informed consent, not willing or able to have oral examination. * diabetes not excluded but screening for diabetes will be performed: glucose will be assessed in blood/serum sample (150ul). exclusion criteria summary: * critically ill participants who cannot give informed consent * those who are not willing to have an oral examination, or donate blood or saliva samples. * those who cannot chew / drool to provide a swmf sample due to severe/critical medical conditions * participants with known malignancies or who are pregnant * participants who are on long-term immunosuppressants (e.g. for autoimmune diseases) * participation in other current research that is designed to, or is expected to alter the immune response. * inability to communicate, understand or read english.

Keywords: covid-19 periodontal disease oral health mucosal immunity
randomized, double-blind, placebo-controlled trial of pregabalin in patients with fibromyalgia.

Conditions: Fibromyalgia

Summary: this study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * acr criteria for fibromyalgia * a score of more or equal to 40 mm on the pain visual analog scale (vas) and a an average score more or equal to 4 on 4 daily pain diaries exclusion criteria: * patients with other severe pain conditions * patients with severe depression * patients taking excluded medications