Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or tzd in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in africa, asia, europe and south america. the aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or tzd (thiazolidinedione) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - japan: age minimum 20 years - subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). stable is defined as unchanged medication and unchanged dose - hba1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) exclusion criteria: - females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - history of chronic or idiopathic acute pancreatitis - screening calcitonin value above or equal to 50 ng/l (pg/ml) - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) - impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m2 per modification of diet in renal disease (mdrd) formula (4 variable version) - acute coronary or cerebrovascular event within 90 days before randomisation - heart failure, new york heart association (nyha) class iv
cognitive effects of adjuvant vortioxetine in early schizophrenia

Conditions: Cognitive Impairment With Primary Psychotic Disorder; Negative Symptoms With Primary Psychotic Disorder

Summary: clinical trial to assess the efficacy of vortioxetine compared with treatment as usual in early schizophrenia.

clinical trial to assess the efficacy of vortioxetine, compared with treatment as usual in early schizophrenia. propose: to investigate the effect of vortioxetine in cognitive functioning and negative symptoms severity in early schizophrenia.

Eligibility criteria:
inclusion criteria: 1. outpatient 2. structured clinical interview for the diagnostic and statistical manual of mental disorders (dsm - scid) diagnosis of schizophrenia spectrum disorders. 3. age \>18-50 years old 4. stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine). 5. no antidepressant treatment for at least 8 weeks prior to randomization. 6. panss negative subscore \>14 with at least two of the items at a level \>/=4 (moderate) 7. panss positive subscore \ /=4 (moderate) 8. hamilton depression rating scale (hamd-17) total score \</=12 9. simpson angus score of any item \<2 10. behaviorally anchored rating scale (bars) of any item \</= 1 11. competent and willing to sign informed consent 12. the patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception exclusion criteria: 1. patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization. 2. structural brain disease (based on previous medical records) 3. cognitive disability by history and estimated intelligence quotient (iq) \<70 (id dsm-5 diagnosis). 4. any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition. 5. organic mental disorders, or mental disorders due to a general medical condition. any neurological or neurodegenerative disorders. 6. any current diagnosis of substance abuse or dependence. 7. serious risk of suicide. 8. patients with thyroid conditions. 9. intolerance to or inefficacy of vortioxetine in the past. patients who had failed treatment with vortioxetine were also excluded. 10. pregnant or breastfeeding female.
effects of structured rehabilitation program on quality of life in rectal cancer patients- a randomized controlled trial

Conditions: Quality of Life; Sexual Function; Urinary Incontinence; Anal Incontinence

Summary: quality of life after rectal surgery is reported to be impaired. side effects of surgery and/or neoadjuvant treatment as functional disturbances like sexual dysfunction, urinary incontinence, anal incontinence or stoma problems are commonly experienced. the investigators hypotheses is that structured rehabilitation program addressing these problems will improve quality of life. a rct are performed in order to document the effects of the rehabilitation.


Eligibility criteria:
inclusion criteria: * rectal cancer surgically treated for rectal cancer informed concent included in national guidelines for surveillance of rectal cancer patients exclusion criteria: * older than 75 years mentally or physically not able to participate non curative surgical treatment

Keywords: urinary function anal function
prevention and intervention of externalizing problem behavior in school: development and evaluation of a teacher coaching.

Conditions: Problematic Behavior in Children

Summary: children with externalizing problem behaviour are at risk of developing educational impairment, because of their problems in rule following, social behaviour and attention. this behaviour represents a great challenge for teacher. in addition, time pressures and conflicts with colleagues are the most common sources of stress for teachers. till now teachers receive no evaluated training which in particular regards externalizing problem behaviour. therefore we develop and evaluate an indicated prevention program for elementary school teachers with children with externalizing problem behaviour. all teachers of a participating school are given a general overview of externalizing problem behaviour (etiology, diagnosis) and information on evidence-based treatments for children with externalizing problem behaviour in school settings. single teachers will then participate in a 12 week coaching in which they learn to apply classroom management techniques, strategies to improve their relationships with children, behaviour modification techniques and cognitive interventions to specific target children. the coaching intervention is based on functional behavioural analysis and provides teachers with evidence-based strategies which focuses on one target child. longitudinal data will be collected in a within-subject control group design. dependent measures include teacher and observer reports.


Eligibility criteria:
inclusion criteria: * age between 6 and 11 years, externalizing behavior problems exclusion criteria: -

Keywords: externalizing problem behavior, teacher training, teacher coaching, primary school, elementary school, continuing professional development, advanced training
a study to evaluate the safety and tolerability and explore the efficacy of zonisamide as add-on therapy in elderly patients with refractory partial seizures

Conditions: Epilepsy

Summary: a two arm, randomized, double-blind study comparing zonisamide with placebo. the zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (aeds).


Eligibility criteria:
key inclusion criteria: 1. capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf. 2. able to complete the questionnaires used in this study. 3. localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the international league against epilepsy (ilae) criteria. 4. have at least one well documented seizure in the 4 weeks preceding the randomisation visit (visit 2) and are deemed to require additional aed medication. 5. receiving at least one, but not more than two other marketed aeds as concomitant medication, and the dosage should be stable for at least four weeks before the screening visit. key exclusion criteria: 1. seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia). 2. seizures which could be attributed to use of a drug. 3. presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, lennox-gastaut syndrome. 4. a history of eating disorders or a body weight below 40 kg. 5. a history of blood dyscrasias. 6. a history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria. 7. an increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders. 8. taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis. 9. taking rifampicin or drugs with anticholinergic effects. 10. taking carbonic anhydrase inhibitors or topiramate. 11. a history of pancreatitis. 12. a history of stevens johnson syndrome. 13. elevated levels of serum creatinine \>165 umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
impact of dexmedetomidine on acute kidney injury following living donor liver transplantation

Conditions: Acute Kidney Injury; Liver Diseases

Summary: acute kidney injury (aki) following liver transplantation (lt) is associated with increased costs, morbidity, and mortality. dexmedetomidine has known to have anti-inflammatory effect and has been shown to ameliorate iri in several organs. however, the impact of dexmedetomidine on aki after lt is not determined yet. therefore, this study aims to observe the renal protective effects of dexmedetomidine after lt.

acute kidney injury (aki) following liver transplantation (lt) has shown a wide range of incidence between 17% and 95% and is associated with increased costs, morbidity, and mortality. the etiology of aki after lt is multifactorial. among these factors, renal ischemia-reperfusion injury (iri) caused by perioperative renal hypoperfusion is considered as one of the most important independent risk factors and recent reports have indicated that iri is associated with an inflammatory cascade. dexmedetomidine which is a highly selective agonist of α2-adrenergic receptors has known have anti-inflammatory effect and has been shown to ameliorate iri in several organs. however, the impact of dexmedetomidine on aki after lt is not determined yet. therefore, this study aims to observe the renal protective effects of dexmedetomidine after lt.

Eligibility criteria:
inclusion criteria: * living liver transplantation recipients exclusion criteria: * preoperative renal dysfunction * dual living donor liver transplantation * severe cerebral artery disease * severe cardio-pulmonary disease

Keywords: dexmedetomidine acute kidney injury liver transplantation
retina microvascularisation and cardiovascular heart disease prediction

Conditions: Cardiovascular Disease

Summary: earlier studies have found that retinal photography could be very useful for evaluating the condition of microcirculation and the risk of cardiovascular diseases in patients. the architectural changes in retinal vascularisation strongly correlates with macrovascular remodeling. also, recent founding suggests a possible close anatomical parallel between both the macrovascular and the microvascular blood. our objectives are to assess (1) in which age and sex subgroups, if any, retinal vascular alteration in arterioles and venules can be predictive for cardiovascular morbidity and mortality; and (2) whether variations in arteriolar or venular caliber will predict better cardiovascular pathogenesis in normal and patient population. if the association between the diameter of the retinal vessels and the risks of cardiovascular disease is verified during this study, the impact on prevention would be enormous. the retinal microvascular change could become a powerful biomarker in the early detection of the cardiovascular pathogenesis and death risk


Eligibility criteria:
inclusion criteria: * age between 50 to 70 years old (male/female) * indication of coronarography within the last 3 month preceding the enrollment * patients with history of stroke, heart failure or arteriosclerosis. * at least one of the following risk factors for cardiovascular complication: * hypertension * coronary heart disease (chd) * diabetes * structural heart disease * dyslipidemia * obesity exclusion criteria: * patients with a permanent pacemaker or icd * nephrosis or chronic renal failure * the study interferes with therapeutic or diagnostic procedures * patients with inability to consent or comply with follow up requirements * patients with glaucoma * patients with any retina degeneration disease vascular age-related macular degeneration or any -retina degeneration disease * patients who are pregnant

Keywords: retinal microvascularisation fundus mfergs chf cardiovascular disease coronarography macrovascularisation the objectives are to assess if if any retinal vascular disorder in arterioles and venules can be predictive for cardiovascular morbidity and mortality
effectiveness of go for transitional housing residents

Conditions: Quality of Life; Wellness, Psychological

Summary: the goal of this pre-post study is to enhance the health and wellness of the residents in the concordia tsat sing kong transitional housing estate. this study aims to evaluate the effectiveness of the green oasis (go) wellness program in: 1. increase health awareness and engaging in health promoting activities, including more physical activities/walking, gardening. 2. enhance happiness and quality of life. participants will: * complete physical exercises, gardening, and interact with the go website * receive health talks


Eligibility criteria:
inclusion criteria: * aged 10 or above. * scored \>6 in the abbreviated mental test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients. * can understand cantonese. * able to take part in light exercise and stretching. * have access to smartphone and internet. exclusion criteria: * have a serious organic disease or malignant tumor. * have a mental disorder diagnosed by neurologists or psychiatrists. * experienced drug addiction
vaccination with autologous, lethally irradiated melanoma cells engineered by adenoviral mediated gene transfer to secrete granulocyte-macrophage stimulating factor (gmsf)

Conditions: Melanoma

Summary: the purpose of this study is to see if the proposed therapy will delay or stop the progression of the participants skin cancer. this study is being done because there are currently no treatments which have been shown convincing to treat disease which has progressed. this research study is designed to evaluate the immunologic effects and clinical side effects of giving vaccines to patients that are made from their own skin cancer cells.

* the vaccines created from the participants melanoma cells are scheduled to be given to the participants on days 1, 8, 15, 29 and every two weeks after until the supply of vaccine has run out. the amount of vaccine is dependent on the total amount of cells yielded when the tumor is processed and treated. it is hoped that participants will receive at least six vaccines. * the vaccines will be administered in two injections that will be placed underneath the participants skin. the two injections will be given at the same place on the body. * if tumor sample yields enough cells, participants will also receive an injection of non-transduced irradiated melanoma cells. the purpose of this is to measure the amount of reaction of the participants immune system occuring created by the vaccine. * if either the vaccine site or dth placement site has shown a reaction, a punch-biopsy will be taken. this will consist of a small piece of skin tissue removed under local anesthesia. * with vaccine #5, participants will receive a second dth injection. two days after the vaccine and dth injection, punch biopsies will be taken of both sites. * at week 10 of treatment (or earlier if necessary), participants will undergo a chest, abdomen and pelvic ct scan. the physician may also have participants undergo a brain mri if indicated at this time.

Eligibility criteria:
inclusion criteria: * stage iii patients must have: a) histologically documented melanoma b) lymphadenopathy of at least 2cm in greatest diameter by physical exam or ct scan in a region draining a known or suspected primary melanoma or in transit metastatic disease of at least 2cm in greatest diameter by physical exam or ct in a region draining a known primary melanoma c) refused, not eligible, or failed adjuvant therapy with high dose a-interferon d) must be able to have all measurable disease removed at time of tumor harvest * stage iv patients must have histologically documented metastatic melanoma * ecog performance status 0 or 1 * estimated life expectancy of 6 months or greater * 18 years of age or older * signed informed consent * greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy * greater than 6 months since bone marrow or peripheral blood stem cell transplant exclusion criteria: * uncontrolled active infection * pregnancy or nursing mothers * evidence of infection with human immunodeficiency virus, hepatitis b or c

Keywords: vaccination gm-csf autologous irradiated
dna analysis of tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at the dna in tumor tissue samples from patients with human papilloma virus-associated cancer of the oropharynx.

objectives: * analyze pik3ca expression and mutation and p110α amplification and expression in tumor tissue samples from patients with human papilloma virus positive (hpv+) and human papilloma virus negative (hpv-) squamous cell carcinoma (scc) of the oropharynx. * determine proliferation and survival after pi3k inhibition in hpv(+) and hpv(-) oropharyngeal scc cell lines and in hpv e6 and e7 expressing cells. * determine proliferation and survival after pi3k inhibition in short-term cultures of tumor tissue samples from patients with hpv(+) and hpv(-) primary scc of the oropharynx. outline: previously collected tumor tissue samples are analyzed for hpv dna by pcr amplification and direct sequencing of pcr products; expression of e6 protein and relative expression of pik3ca by qrt-pcr; amplification of pik3ca by southern blotting; mutation of pik3ca; expression of p110α, phospho-akt, total akt, and foxo1 by polyacrylamide gel electrophoresis (page) and immunoblotting; and the effect of pi3k inhibition on cell cycle and apoptosis by flow cytometry. pharmacological studies are performed on oropharyngeal squamous cell carcinoma cell lines and short-term cultures and hpv e6 and e7 expressing cells using ly 294002 in vitro to analyze response to pi3k inhibition. results of response to pi3k inhibition will be correlated with hpv status, pik3ca expression, amplification, and mutation, and p110α expression. projected accrual: a total of 20 hpv(+) and 20 hpv(-) tumor tissue specimens from patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * undergoing operative procedures for biopsy and/or resection of squamous cell carcinoma (scc) of the oropharynx * tumor tissue sample available from the head and neck tissue repository and clinical database of vanderbilt university * no tumors with human papilloma virus (hpv) dna sequences but no expression of e6 patient characteristics: * see disease characteristics prior concurrent therapy: * not specified

Keywords: recurrent squamous cell carcinoma of the oropharynx stage i squamous cell carcinoma of the oropharynx stage ii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the oropharynx
efficacy and safety of jaktinib in participants with severe novel coronavirus pneumonia(covid-19)

Conditions: COVID-19; Pneumonia

Summary: this study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.


Eligibility criteria:
inclusion criteria: * 18 years of age, male or female; * the participants was diagnosed with novel coronavirus pneumonia; * it meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9). * participants who voluntarily sign informed consent. * the national institute of allergy and infectious diseases sequential scale (niaid-0s) score is 5 or 6; exclusion criteria: * participants who cannot take orally, or are suspected to be allergic to jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption; * participants who have received the following treatments within the specified time window before randomization: 1. participants have received janus kinase (jak) inhibitor, interleukin 6 (il-6) inhibitor, il-1 inhibitor, tumor necrosis factor (tnf) inhibitor, t cell or b cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid; 2. systematically used cyp 3a4 potent inhibitor or potent inducer in the first five drug half lives at random; * immune deficiency;