Kornimate/medical-research-clean huggingface dataset:
deciphering the role of circular rnas in alkpositive anaplastic large-cell lymphoma

Conditions: ALK-Positive Anaplastic Large Cell Lymphoma

Summary: the objective of the project is to determine, whether circrnas could be used as circulating prognostic and/or predictive biomarkers of alk+ alcl resistance to treatment and whether they can be exploited as therapeutic targets.

anaplastic large-cell lymphoma (alcl) is an aggressive t-cell pediatric lymphoma. 85% of alk+ alcl cases harbor a fusion between the nucleophosmin (npm) and anaplastic lymphoma kinase (alk) genes, leading to a constitutively activated and oncogenic fusion protein. most alk+ alcl cases initially respond well to the frontline chemotherapy, but 30% of patients relapse and are of poor prognosis. understanding the origins of therapy resistance is of major importance to improve treatment and patient prognosis. current research highlights deregulated expression of regulatory non-coding rnas (ncrnas) as an important factor in therapy resistance. to date, micrornas and long noncoding rnas have been linked to therapy resistance in alk+ alcl. circular rnas (circrnas) are a class of highly stable noncoding rnas that have recently come into the focus of researchers. circrnas can control target gene expression by e.g. interacting with micrornas or proteins. this project aims to elucidate their role in alk+ alcl biology including their impact on noncoding rna networks and therapy resistance. this project will (1) identify a signature of circrnas associated with therapy resistance in alk+ alcl, (2) analyze their effect on treatment response, (3) elucidate their mechanism of action, and (4) evaluate circrna candidates as predictive and prognostic plasma biomarkers using liquid biopsies. the goal of the study is to characterize the role of candidate circrnas in this well-defined cancer type, which can serve as a model for other alk+ cancers. project results will add to the current mechanistic understanding of alk+ alcl pathogenesis and the origins of therapy resistance, and could define new druggable targets and associated predictive biomarkers for high-risk disease. establishing the blood-based alternative confirmation for the alk+ alcl diagnosis could also produce a less invasive predictive tool capable of longitudinal patient monitoring for early relapse detection.

Eligibility criteria:
inclusion criteria: * patient at diagnosis of alk+ alcl * patient at the time of relapse for alk+ alcl * patient without alk+ alcl exclusion criteria: -

Keywords: cancer
comparison of two volar plating systems for distal radius fractures

Conditions: Distal Radius Fracture

Summary: we plan to compare 2 types of plating systems for volar plating of distal radius fractures (aptus 2.5® medartis ag, basel, switzerland vs. inteos 2.5® - hofer medical gmbh and co kg, austria) in a prospective single-blinded controlled clinical trial.

this study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures. patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. informed written consent will be obtained. envelopes will be prepared containing equal number of cards representing either the conventional or the novel plating syste. on the morning of the surgery a randomly picked envelope decides allocation one of the study groups. patients will be blinded to treatment until completion of the study. patients allocated to the control group receive aptus 2.5® volar plate for distal radius fractures (medartis ag, basel, switzerland), while patients in the study group will receive the plating system inteos 2.5® (hofer gmbh and co kg, austria). in the control group, the pronator quadratus muscle will be cut prior mounting of the plate, while in the treatment group the plate will be inserted underneath the pronator quadratus leaving the muscle intact.

Eligibility criteria:
inclusion criteria: * " distal radius fracture, type a2, a3, b1, b2, b3, c1, c2 (according to ao müller classification3) " patient age between 18 and 75 years " closed fracture or i° open fractures (according to gustilo-anderson classification6) " agreement of patient to participate and written informed consent exclusion criteria: * " polytraumatized patients " severe systemic disorder (asa 3) " new and/or preexisting fracture/injury of contralateral forearm " ii° and iii° open fractures (according to gustilo-anderson classification6) " associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " non-compliance to postoperative protocol (e.g. physiotherapy) " delayed definitive surgical treatment of more than 14 days after injury " change from temporary procedure (e.g. fixateur externe) " complex regional pain syndrome (crps, m.sudeck) " loss to follow-up
efficacy and safety of lu aa34893 in patients with bipolar depression

Conditions: Depression in Patients With Bipolar Disorder

Summary: this study will evaluate the efficacy and safety of different doses of lu aa34893 in the treatment of depression in patients with bipolar disorder.

bipolar disorder is a common lifelong psychiatric disorder. it is characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. patients spend more time in depression than in (hypo)mania over their life time. the medical need for the patient is to remain symptom-free for as long a period as possible. a reduction both in severity of depression and mania, and in frequency of cycling, is the aim. although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. there is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. this study evaluates the efficacy and safety of the new drug, lu aa34893, in treatment of depression in patients with bipolar disorder.

Eligibility criteria:
inclusion criteria: * current major depressive episode of bipolar i or bipolar ii disorder, according to dsm-iv tr * moderate to severe depression * history of at least one documented mania or hypomania episode * absence of current mania or hypomania exclusion criteria: * any current psychiatric disorder other than bipolar disorder defined in the dsm-iv tr * any substance disorder with the previous 6 months * use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study * ect within 6 months before the study * female of childbearing potential and not using adequate contraception other protocol-defined inclusion and exclusion criteria may apply

Keywords: depression bipolar disorder placebo-controlled double-blind multicenter clinical study mania
exercise consultation in obese youth

Conditions: Obesity

Summary: exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (pa) among adults. it is unknown whether this approach would be efficacious with youth. the purpose of this pilot study was to assess whether exercise consultation would increase pa levels and improve anthropometric measures and metabolic markers in obese adolescents.


Eligibility criteria:
inclusion criteria: * adolescents * bmi greater than or equal to the 95th percentile for age (2000 cdc growth charts) exclusion criteria: * pregnancy * underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity

Keywords: obesity physical activity adolescents exercise counseling intervention
mindray neuromuscular transmission transducer

Conditions: Neuromuscular Blockade

Summary: a new nmt module from mindray (mindray co. shenzhen, people's republic of china.) claims to measure 3 directional accelerography. the aim of the study is to compare the neuromuscular block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ed95) monitored by the nmt versus that monitored by the relaxometer mechanomyograph on the other hand in group 1, and versus the tof-watch on the other hand in group 2 to clinically evaluate the new system for its diagnostic accuracy.

mechanomyography (mmg) is regarded as the standard method for precise quantification of neuromuscular block. the conventional mmg measures the exact force of muscle contraction in response to electric stimulation of the ulnar nerve. mmg quantifies the neuromuscular function by measurement of the force displacement. however the equipment is rather bulky, takes time to set up, requires a rigid support of the arm in an often-crowded operating room. this limits its clinical use in the daily anesthesia practice. acceleromyography is based on the acceleration of a piezo-electrode. a new nmt module from (shenzhen, people's republic of china.) claims to measure 3 directional accelerography. the aim of the study is to compare the neuromuscular block of rocuronium 0.6 mg/kg (twice the 95% effective dose, ed95) monitored by the nmt to that monitored by the relaxometer mechanomyograph in group 1, and versus tof-watch acceleromyograph in group 2 to clinically evaluate the new system for its diagnostic accuracy.

Eligibility criteria:
inclusion criteria: * 24 patients with mindray nmt monitoring on one hand versus mmg mechanomyograph on the other hand in group 1 with both hands accessible in supine position alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg * 24 patients with mindray nmt monitoring one hand versus tof-watch acceleromyograph on the other hand in group 2 with both hands accessible in supine position alternately right and left hands monitoring neuromuscular block of rocuronium neuromuscular blocking agent 0.6 mg/kg. exclusion criteria: * both hand inaccessible in supine position, patients receiving drugs interfering with rocuronium neuromuscular block, or patients with small joint arthritis that could affect neuromuscular monitoring.

Keywords: neuromuscular block monitoring
comparison of volatile anesthetics on cerebral oxygenation during controlled hypotension

Conditions: Oxygen Saturation

Summary: controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. on this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.


Eligibility criteria:
inclusion criteria: * patients in american society of anesthesiology (asa) classification i and ii * patients undergoing elective septoplasty operation exclusion criteria: * patients in asa classification iii and higher * emergency surgery * patients in new york heart association classification iii-iv * patients with known allergy to drugs used in the study
neural mechanisms of mindfulness-based cognitive therapy (mbct) for posttraumatic stress disorder (ptsd)_va only

Conditions: Post Traumatic Stress Disorder

Summary: this study will examine the effects of psychotherapy as treatment for ptsd. this research will see how brain activity and brain connectivity is affected by mindfulness based cognitive therapy (mbct) and muscle relaxation therapy (mrt). participants that qualify to be in this study will receive 8 weeks of group therapy in mbct or mrt. prior to receiving therapy participants will: complete baseline assessments related to their ptsd; fill out surveys; have an functional magnetic resonance imaging (fmri); and provide a saliva sample. these assessments will be repeated after the therapy is over. overall study participation should last approximately 10-12 weeks.

note: due to covid precautions, treatment shifted from in-person to remote ("zoom" videoconferencing)

Eligibility criteria:
inclusion criteria: * meets current diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for ptsd (with or without major depressive disorder) or subsyndromal ptsd (qualifying trauma, and at least one intrusive, one avoidant, one negativity, and one arousal symptoms, and significant impairment or distress); type of trauma shall include interpersonal violence - combat, physical assault, sexual assault, etc. exclusion criteria: * dissociative ptsd * delayed-onset ptsd * magnetic resonance imaging (mri) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.) * serious medical or neurologic conditions (e.g. stroke, seizures) * suicide risk * psychosis * life history of schizophrenia * life history of bipolar disorder * current severe substance use disorder * other factors that preclude safe and meaningful participation in the study, at discretion of the pi and study team

Keywords: mindfulness-based cognitive therapy muscle relaxation fmri group psychotherapy
randomized trial of psma pet scan before definitive radiation therapy for prostate cancer

Conditions: Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8

Summary: this randomized phase iii trial studies the success rate of definitive radiation therapy (drt) for prostate cancer (pca) with or without planning based on psma pet. psma- pet-based drt, may improve radiation therapy planning and patient selection for drt, and potentially improve its outcome compared to drt without psma pet (standard drt).

primary objective: i. to compare the outcome of patients with unfavorable intermediate (ir) and high-risk (hr) prostate cancer (pca) after standard drt versus prostate-specific membrane antigen (psma) positron emission tomography (pet)-based drt. outline: patients are randomized to 1 of 2 arms. in both arms, no other primary treatment should be given before rt. arm i: patients do not undergo psma pet for drt planning. patients undergo standard of care drt at the discretion of the treating radiation oncologist. arm ii: patients undergo psma pet for drt planning. patients then undergo drt at the discretion of the treating radiation oncologist, who receives the psma pet result and images. after completion of drt, clinical follow-up of patients with their treating radiation oncologist will be obtained for 5 years. the investigators will rely on the medical records obtained from the treating physicians as the primary source of outcome data.

Eligibility criteria:
inclusion criteria: * adult male 18 years or older * histopathologically-proven pca * unfavorable ir to hr disease: * prostate specific antigen (psa) \>= 10 ng/ml * or ct-stage \>= 2b * or gleason grade 3 (4+3=7) or higher * or gleason grade 2 (3+4=7) and \>= 50% positive biopsy cores * or decipher score \>= 0.45 * treating radiation oncologist intends to incorporate psma pet findings into the radiotherapy plan, if patient undergoes psma pet (intervention arm 2) * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * less than 18 years old at the time of investigational product administration * extra-pelvic metastasis (m1 disease) on any imaging or biopsy done before randomization * prior psma pet * prior pelvic rt * contraindications to radiotherapy (including active inflammatory bowel disease) * concurrent or prior surgery or systemic therapy for pca at the time of randomization

Keywords: psma pet/ct randomized trial definitive radiation therapy prostate cancer
study to evaluate safety, tolerability, efficacy and pharmacokinetics of asc10 in mild to moderate covid-19 patients

Conditions: SARS CoV 2 Infection

Summary: this is a phase ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of asc10 tablets in mild or moderate covid-19 subjects.


Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥18 years at screening; 2. those females who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose; 3. if male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug; 4. has a documentation of pcr-confirmed sars-cov-2 infection with sample collection ≤5 days prior to randomization. exclusion criteria: 1. females who are pregnant, planning to become pregnant, or breastfeeding; 2. has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from covid-19; 3. has hypersensitivity or other contraindication to any of the components of the study interventions; 4. has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

Keywords: asc10 rdrp
prospective evaluation of the statusfirst™ chf nt-probnp device in human whole blood and plasma samples

Conditions: Congestive Heart Failure (CHF)

Summary: the primary objective of the study is to establish the correlation between nt-probnp measurements in fresh human whole blood samples and those in plasma samples from the same study subjects, where said samples are collected in edta and li-hep anticoagulant tubes and measured by the statusfirst™ chf nt-probnp device in conjunction with the dxpresstm reader in a laboratory setting.


Eligibility criteria:
inclusion criteria: * have clinically confirmed heart failure (nyha class i-iv) or have presented to an emergency room or clinic with signs, symptoms and/or risk factors suggestive of heart failure, or * be non-chf controls greater than 45 years of age with no history of heart failure or cardiovascular disease. exclusion criteria: * be 45 years of age or younger

Keywords: congestive heart failure (chf) nt-probnp
assessment of a vaginal ring with meloxicam in the treatment of dysmenorrhea

Conditions: Dysmenorrhea

Summary: the investigators propose that the sustained administration of a vaginal ring would have a better response with respect to pain and a better safety profile than the oral administration of a non-steroidal anti-inflammatory drug. to assess the relief of the symptoms associated with dysmenorrhea, a specific survey was elaborated that also includes a visual analog scale (vas) to objectify and measure dysmenorrhea as is the case with mcgill's pain questionnaire (mpq).


Eligibility criteria:
inclusion criteria: * regular menstrual cycles on previous 3 months (24-35 days), * primary dysmenorrhea on 3 previous months, * with tubal ligation or users of condom for contraception, * hemoglobin of at least 11 g/dl, * safety blood analysis in normal levels exclusion criteria: * secondary dysmenorrhea, * users of hormonal contraceptives (2 months prior to the study) or intrauterine devices (iuds) (1 month prior the study). * allergy to any anti-inflammatory drug including meloxicam or diclofenac. * allergy to silicon. * pregnant or in lactation. * women with untreated or decompensated endocrine disorders
phase 3 study of surgery combined with neoadjuvant chemotherapy(xelox) in colorectal cancer with resectable liver metastasis

Conditions: Colorectal Cancer; Resectable Liver Metastasis

Summary: this study aims to discuss the efficacy and safety of neoadjuvant chemotherapy with xelox regimen (oxaliplatin plus capecitabine) .

liver metastasis is the most important prognostic factor of colorectal cancer. reasonable multidisciplinary therapy might improve the prognosis of patients with liver metastasis. surgery has been the first choice under such situation. recently, neoadjuvant chemotherapy has also shown its value in unresectable liver metastasis, for it can increase the chance of r0 resection and give some clues to chemosensitivity of agents. however, for those resectable lesions, the role and safety of neoadjuvant chemotherapy has yet to be confirmed. so we design this study.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal cancer with liver metastasis(all patients should have the pathological report of colorectal cancer. the chances of hepatocellular carcinoma or metastasis from other primary lesions should be excluded. ) 2. liver metastasis should be resected with r0 resection and to save enough normal liver tissue 3. anticipated liver resection: for normal liver, ﹤70%; for liver with cirrhosis, ﹤50% 4. no metastasis of other organs or lymph nodes in abdominal cavity 5. no previous use of oxaliplatin and capecitabine, or previous adjuvant treatment ended more than 6 months 6. age 18 to 75 years old 7. karnofsky performance status ≥70 8. life expectancy of ≥3 month 9. bilirubin level \< 1.5mg/dl 10. serum creatinine \<1.0 times uln 11. absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, hb\>9g/dl 12. having signed informed consent exclusion criteria: 1. previous use of oxaliplatin or fluorouracil-based chemotherapy in 6 months. 2. no r0 resection or not enough normal liver tissue left 3. previous radiotherapy of target lesions 4. accompanied with unresectable other metastasis or malignant pleural fluids or ascites. 5. complete or uncompleted liver obstruction 6. peripheral neuropathy(nci-ctc grade 1 or more) 7. mental disturbance neuropathy that influence the cognition, including brain metastasis 8. other serious disease such as uncontrollable active infection, heart infarction with 1 year, un controlled hypertension, arrhythmia with high risk, or unstable heart infarction,heart failure, coronary artery disease, myocardial infarction within the last 6 months 9. other previous malignancy within 5 year, except non-melanoma skin cancer 10. accompany with other anti-tumor therapies,including immune therapy, intervention or injection with chemotherapeutical agents into serous cavity, or participating other clinical trials. 11. pregnancy or lactation period