Kornimate/medical-research-clean huggingface dataset:
a randomized, double-blind, parallel-arm, placebo and active controlled dose-ranging study of the efficacy and safety of multiple doses of tapentadol ir for postoperative pain following bunionectomy surgery

Conditions: Pain; Postoperative Pain

Summary: this study was to evaluate the efficacy and safety of dosing regimens of tapentadol hcl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the first day following a bunionectomy in men and women.

tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. this was a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose study in men and nonpregnant, nonlactating women. the patients were at least 18 and no more than 75 years of age and experienced moderate to severe pain within 9 hours after removal of postoperative analgesia. the surgery was a standardized first metatarsal bunionectomy. treatment of postsurgical pain after the 9 hr period was with either placebo, tapentadol, or oxycodone using various dosing regimens. the primary objective of this study was to evaluate the efficacy and safety of these treatments on total pain relief and total change in pain intensity over 12 hours and reporting of adverse events, laboratory values, vital signs, and ecgs. secondary objectives included evaluation of several other pain measures, and drug pharmacokinetics and pharmacodynamics. six patient treatment groups received study medication orally at 0, 4, and 8 hours with one of the following dosing regimens: 1) placebo, placebo, and placebo, 2) 93 mg, 93 mg, and 93 mg tapentadol ir, 3) 140 mg, 140 mg, and 140 mg tapentadol ir, 4) 140 mg, 70 mg, and 70 mg tapentadol ir, 5) 186 mg, 93 mg, and 93 mg tapentadol ir, and 6) 10 mg, 10 mg, and 10 mg oxycodone ir.

Eligibility criteria:
inclusion criteria: * moderate to severe pain intensity within 9 hours of the discontinuation of the popliteal block, and permitted supplemental systemic analgesics, if taken, during the postoperative surgical period * moderate to severe categorical pain intensity and a pain intensity vas = 40 mm exclusion criteria: * randomization less than 10 hours after initiation of the standardized first metatarsal bunionectomy * history of seizure (including febrile seizure), or loss of consciousness due to head trauma * use of antiparkinsonian drugs, neuroleptics, anticonvulsants, monoamine oxidase inhibitors (maois), tricyclic antidepressants (tcas), ssris, and snris at any time within 30 days of surgery and throughout the study period

Keywords: tapentadol bunionectomy analgesia acute pain postsurgical pain
digital biofeedback system versus conventional rehabilitation after rotator cuff repair

Conditions: Rotator Cuff Tear

Summary: this study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions. the investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation. patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. both groups will perform a 12 to 16-week rehabilitation program starting immediately after surgery. outcomes will be measured at baseline, 8 and 12 weeks. in patients where a decision is made to extend the program to 16 weeks, another assessment will be made at this point.


Eligibility criteria:
inclusion criteria: * shoulder pain and functional limitation with clinical examination compatible with rotator cuff tendinopathy * imaging (mri or ultrasound) evidence of rotator cuff tear (supra and/or infraspinatus tendon tear inferior to 3 cm? or 5cm?) * indication for a simple rotator cuff repair according to the patient´s orthopedic surgeon * ability to understand simple and complex motor commands * availability of a carer to assist the patient after surgery exclusion criteria: * patients admitted for revision cuff repair * complex cuff tears (involving subscapularis tendon or more than one tendon besides supra and infraspinatus, or massive dimension tears) * glenohumeral arthritis * irreparable tendon defect * patients with concomitant neurological disorders (ex. stroke, parkinson´s disease, multiple sclerosis) * aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process * respiratory, cardiac, metabolic conditions or others incompatible with at least 30 minutes of light to moderate physical activity * major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after surgery * other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program * blind and/or illiterate patients
ramps vs srps for pancreatic body and tail adenocarcinoma

Conditions: Radical Antegrade Modular Pancreatosplenectomy

Summary: two arms rct is design, patients with pancreatic body or tail adenocarcinoma will be randomly assigned to the radical antegrade modular pancreaticosplenectomy (ramps) group or standard retrograde pancreatosplenectomy (srps) group. the primary objective is to evaluate the effect of ramps on the overall survival of patients with resectable body and tail pancreatic ductal adenocarcinoma. and the secondary objective is to evaluate the disease-free survival, r0 resection rate, number of retrieved lymph nodes and perioperative outcomes like postoperative complication rate, severe complications, mortality and functional recovery time between the experimental group and control group.


Eligibility criteria:
inclusion criteria: * age 18-80 years old; * resectable pancreatic body and tail ductal adenocarcinoma with both preoperative and intraoperative evaluation(refer to nccn guideline 2018 of pancreatic cancer); * ecog performance status 0-1; * adenocarcinoma of pancreatic body and tail duct, without distant metastasis and ascites; * the estimated survival time is ≥ 3 months; * follow-up in time and obey the research requirements; * be voluntary to this clinical trial and can sign the informed consent; * normal hematological index (leukocyte, platelet, liver function, renal function, dic, electrolyte index, hb \>10g/dl). exclusion criteria: * the patients with distant metastasis according to preoperative tumor staging; * patients with recurrent pancreatic ductal adenocarcinoma; * the artery or vein is involved and could not be resected or reconstructed(according to preoperative evaluation or intraoperative evaluation after exploration); * patients with cardiopulmonary disfunction and cannot tolerate operation; * the patients accepted neoadjuvant chemotherapy and radiotherapy before operation; * patients with other malignancies or hematopathy * before the operation, the total bilirubin was more than 250 μmol/l without preoperative biliary drainage or after biliary drainage, the total bilirubin was still more than 250 μmol/l; * pregnancy diagnosed, planned pregnancy and lactating female patients * refusal to sign consent. * intraoperative exclusion include:tumor metastasis; not pancreatic primary disease; unresectable pancreatic body/tail adenocarcinoma * postoperative exclusion include: not pancreatic ductal adenocarcinoma according to pathological examination. * withdrawal of informed consent; * willingness to withdraw from the study.

Keywords: radical antegrade modular pancreatosplenectomy standard retrograde pancreatosplenectomy pancreatic body and tail adenocarcinoma
study to evaluate safety, efficacy and immunogenicity of acne mrna vaccine in participants with mild acne

Conditions: Acne

Summary: the purpose of the vbe00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the acne mrna vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. this study will consist of a sentinel cohort and a main cohort, with the sentinel cohort assessing the safety in a stepwise manner.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator * clinical diagnosis of mild facial acne vulgaris with: * iga score of mild (grade 2 on the 5-grade iga scale) and * between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) and * between 5 to 19 inflammatory lesions (ie, papules and pustules) and * no nodulocystic lesions (ie, nodules and cysts) exclusion criteria: participants are excluded from the study if any of the following criteria apply: * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol \[peg\], polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mrna coronavirus disease 2019 (covid 19) vaccine * previous history of myocarditis and/or pericarditis and/or myopericarditis * skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy * excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection * receipt of immune globulins, blood or blood-derived products in the past 3 months * self-reported or documented seropositivity for human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus
copeptin as a stress marker during a written examination

Conditions: Healthy

Summary: to investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.


Eligibility criteria:
inclusion criteria: * age over 18 years * member of 4th year in medical course at basel university exclusion criteria: * intake of any medication (except birth control pill) * bmi over 30kg/m2 * evidence of acute disease * history of chronic illness, including chronic psychiatric disease * anamnestic certain or assumed pregnancy * regularly smoking students

Keywords: medical students basel university
the various effects of gaseous albuterol on serum lactate

Conditions: Asthma

Summary: empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy. it is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment. this study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.

approximately 30 healthy volunteers will be randomized to albuterol or placebo. we powered our study to detect a difference of 0.5 mmol/l, but hypothesize that the difference will be greater than 1.0 mmol/l. all volunteer subjects will sign a written consent, approved by the institutional review board. the intended pool of volunteers will be from residents, attendings, and medical students in the hospital. the consent form will clearly specify that their participation in the study will not impact their academic status or employment. the subjects randomized to the albuterol arm will receive a one hour 10 mg continuous albuterol nebulizer treatment. those randomized to placebo will receive a one-hour saline nebulizer treatment. the chief pharmacist for the study will randomly assign a number between one and thirty to fifteen albuterol treatments and fifteen placebo treatments. subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.

Eligibility criteria:
inclusion criteria: * 18 years or older exclusion criteria: * pregnant * prisoner * beta agonist allergy * hypokalemia * taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide * coronary artery disease * hyperthyroidism * abnormal heart rhythm * baseline serum lactate level \>2.2 mmol/l * baseline heart rate \> 120

Keywords: albuterol serum lactate lactic acidosis asthma
covid-19 seroprevalence study in itm staff

Conditions: Covid19

Summary: in belgium, the corona virus disease 2019 (covid-19) epidemic is in the growing phase of its second wave. the belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. to decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful. this study will be conducted on staff members of the itm. all staff members will be invited to participate. participants will be asked to have a blood sample drawn for detections of antibodies against sars-cov-2 (using one of these two commercial assays: anti-sars-cov-2 elisa (euroimmun) or wantai sars-cov-2 ab elisa (wantai sars-cov-2 diagnostics)) and to complete a questionnaire about their exposure, both within and outside the itm, to the sars-cov-2, and about their health and symptoms. the primary objective is to estimate the occurrence rate of anti-sars-cov-2 antibodies or seroprevalence in itm staff. secondary objective is to estimate the sars-cov-2 seroprevalence in itm staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to covid-19 patients/samples, comorbidities, adherence to containment measures.

the study is observational and will be conducted on itm staff members. all members will be invited to participate.

Eligibility criteria:
inclusion criteria: * be an active itm staff member * be willing and able to complete the questionnaire * be willing and able to provide informed consent exclusion criteria: * doctor of philosophy (phd) students, master students and interns of the itm

Keywords: humans covid-19 pandemics sars virus cross-sectional studies seroepidemiological studies belgium risk factors seroprevalence
study evaluating tti-237 in advanced malignant solid tumors

Conditions: Neoplasms

Summary: the purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (mtd) of tti-237 for the treatment of subjects with advanced malignant solid tumors.


Eligibility criteria:
inclusion criteria: * documented diagnosis of malignant solid tumor with measurable disease * life expectancy of at least 12 weeks * ecog performance status of 0, 1, or 2 exclusion criteria: * recent major surgery, radiation therapy or anti-cancer treatment * history of any other prior malignancy within the last 5 years

Keywords: tumors advanced malignant solid tumors
vr in diabetic polyneuropathy

Conditions: Diabetic Polyneuropathy

Summary: this study is an experimental single centre study investigating the effect of vr on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years old * able to speak dutch/french * continuing usual care regarding medication use 3 weeks prior and during study participation * diagnosis of dpn for 6 months or longer, confirmed on emg exclusion criteria: * history of seizures/epilepsia * susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia * shift workers
vebreltinib plus plb1004 as the first-line therapy for patients with egfrm+/met+ locally advanced or metastatic nsclc.

Conditions: Non-Small-Cell Lung Cancer

Summary: efficacy and safety evaluation of vebreltinib plus plb1004 as the first-line therapy for patients with egfrm+/met+ locally advanced or metastatic nsclc.

a multicenter,randomized,open-label,phase ii study to evaluate the efficacy and safety of vebreltinib plus plb1004 as the first-line therapy for patients with egfrm+(exon 19 deletion or exon 21 l858r)/met+ locally advanced or metastatic non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: 1. ability to understand and willingness to sign a written informed consent document. 2. aged at least 18 years old. 3. histologically or cytologically confirmed locally advanced or metastatic nsclc (stage iiib\~iv). 4. patients with previously untreated, egfrm-positive (exon 19 deletion or l858r) and met overexpression (ihc 3+) . 5. at least one measurable lesion as defined by recist v1.1. 6. ecog performance status 0 to 1. exclusion criteria: 1. there are mutations of alk or ros1. 2. have symptomatic and neurologically unstable central nervous system (cns) metastases or cns disease that requires increased steroid doses for control. 3. pregnant or nursing women.

Keywords: nsclc lung cancer met amplification egfr l858r egfr exon 19 deletion egfr
oral microbiome is associated with the response to chemoradiotherapy in initial inoperable patients with esophageal squamous cell cancer

Conditions: Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Initial Inoperable

Summary: esophageal cancer accounts for more than half of the world, seriously affecting people's health in china. 95% patients are squamous cell carcinoma. surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage t4b or other surgical contraindications have no surgical opportunity. in recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. a large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. in summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.


Eligibility criteria:
inclusion criteria: * 18-85 years old; * eastern cooperative oncology group (ecog) 0-2; * esophageal squamous cell carcinoma; * ct2-4an0-3m0 (ajcc 8th) confirmed by radiological examination; * initial unresectable at initial diagnosis confirmed by thoracic surgeons; * treatment naive; * no contraindications for adjuvant chemoradiotherapy; * signature of inform consent. exclusion criteria: * • younger than 18 years old or older than 85 years old; * ecog\>2; * esophageal adenocarcinoma, small-cell cancer and other pathological types; * ct1anynm0, ct4banynm0, c anytanynm0 confirmed by radiological examination; * resectable at initial diagnosis confirmed by thoracic surgeons; * previous treatment of chemotherapy, radiotherapy, and other treatment; * contraindications for chemoradiotherapy; * no signature of inform consent.
study of the effects of carbohydrate counting

Conditions: Type 1 Diabetes

Summary: the investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. the investigators want to test the hypothesis in this study.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * diabetes duration at least 12 months * mdi therapy * hba1c 8-10,5% (both included) exclusion criteria: * gastroparesis * present or former practice of carbohydrate counting * pregnancy or nursing

Keywords: carbohydrate counting insulin bolus calculation
moms managing attention-deficit/hyperactivity disorder (adhd) study

Conditions: ADHD; Parenting

Summary: the study will develop and test a behavioral program for pregnant individuals with attention-deficit/hyperactivity disorder (adhd). this behavioral program will include skills for managing adhd and related symptoms during pregnancy and after delivery and will be taught by a behavioral therapist in ob care settings.

treating pregnant individuals with adhd may improve parent and child wellbeing, parent-child interactions, and psychosocial familial factors to enhance family resilience and reduce prevalence/severity of child mental health disorders. using the information provided from stakeholder interviews and adaptations of an existing cbt intervention for parents of children with adhd, the current study will develop the momma (moms managing adhd) intervention and implement it via an open clinical trial (n=10 pregnant individuals), delivered by masters-level women's health behavioral therapists. investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers) and qualitative data (e.g., feedback interviews). in addition, quantitative data (self-reported symptoms, parenting, and home environment measures; observed parent and child behavior; parent reported child temperament/behavior) will be used to assess parent and child outcomes following the intervention. this mixed-methods model will offer a comprehensive examination of the momma intervention and inform a refined intervention model.

Eligibility criteria:
inclusion criteria: * (1) meet full dsm-5 criteria for adhd * (2) are between 20- and 32-weeks of gestation * (3) speak english * (4) will deliver at the university of pittsburgh medical center (upmc) magee women's hospital (mwh) exclusion criteria: * (1) active substance use disorder * (2) intellectual disability * (3) other severe mental illness, including bipolar disorder, psychosis, and major depressive disorder with suicidal ideation or requiring higher level of care (inpatient or partial/intensive outpatient) * (4) high risk pregnancies requiring transfer of care to maternal-fetal medicine (e.g., maternal cancer, multiples, placenta accreta) and/or fetus known to have a severe congenital condition.