Kornimate/medical-research-clean huggingface dataset:
a community-based advance care planning programme for patients with advanced disease

Conditions: Chronic Disease

Summary: advance care planning has been recommended as an integral part of care for patients with life-limiting disease, but relevant development in hong kong is still in its infancy. this proposed study attempts to address this service gap by promoting advance care planning to patients with advanced disease. it is hypothesized that the proportion of patients whose end-of-life care preferences were known in the experimental group will be significantly higher than that in the control group.

this study aims to evaluate the impacts of a community-based advance care planning programme on end-of-life care of patients with advanced disease. a mixed-method approach, including a randomized controlled trial and qualitative interviews, will be used. participants in the experimental group will received a structured advance care planning programme delivered by a trained facilitator. it includes an educational component, reflection and a family meeting.

Eligibility criteria:
inclusion criteria: * aged 18 or above * meet one of the three triggers for supportive /palliative care as suggested in the gold standards framework * living at home * being communicable exclusion criteria: * mentally incompetent * cannot nominate a family carer * have already signed an advance directive * have been referred to palliative care service

Keywords: end-of-life care treatment decision making advance care planning
clinical evaluation for digital acupuncture manipulation therapeutic instrument

Conditions: Cervical Spondylosis

Summary: the investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the visual analogue scale(vas), neck disability index scale (ndi) and short form 36-item questionnaire (sf-36).

based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. the biocompatibility of shock wave was detected by massachusetts general hospital needle sensation scale ((massachusetts general hospital acupuncture sensation scale, mass)). the visual analogue pain score ((visual analogue scale, vas)), neck disability index scale ((neck disability index,ndi) and short form 36-item questionnaire (sf-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.

Eligibility criteria:
inclusion criteria: 1. neck pain with the diagnosis of cervical spondylotic radiculopathy; 2. aged between 18-70 years; 3. have not participated in any drug clinical trials within the last month; 4. voluntarily joining this study with informed consents exclusion criteria: 1. a history of cervical spine trauma or have received cervical spine surgery; 2. accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression; 3. cervical spondylosis in urgent need of surgery; 4. pregnant women and lactating women; 5. a serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition 6. anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks

Keywords: digital acupuncture manipulation therapeutic instrument cervical spondylosis
study testing convalescent plasma vs best supportive care

Conditions: Pneumonia, Interstitial

Summary: currently there are no proven treatment option for covid-19. human convalescent plasma is an option for covid-19 treatment and could be available from people who have recovered and can donate plasma.

experience from prior outbreaks with other coronaviruses, such as sars-cov-1 shows that convalescent plasma contains neutralizing antibodies to the relevant virus. in the case of sars-cov-2, the anticipated mechanism of action by which passive antibody therapy would mediate protection is viral neutralization. the only antibody type that is currently available for immediate use is that found in human convalescent plasma. as more individuals contract covid-19 and recover, the number of potential donors will continue to increase. the investigators seek to treat participants who are sick enough to warrant hospitalization prior to the onset of overwhelming disease.

Eligibility criteria:
inclusion criteria donor: * 18 years or older * must have been hospitalized w/covid-19 respiratory symptoms and confirmation via covid-19 sars-cov-2 rt-pcr testing but are now pcr negative by 2 nasopharyngeal testing * females of child-bearing potential must have a negative serum pregnancy test * subject and/or lar willing to provide informed consent * patient agrees to storage of specimens for future testing inclusion criteria recipient: * 18 years or older * must have been hospitalized w/covid-19 respiratory symptoms within 3 to 7 days from the beginning of illness * subject and/or lar willing to provide informed consent * patient agrees to storage of specimens for future testing exclusion criteria: * 18 years or older * receipt of pooled immunoglobulin in past 30 days * contraindication to transfusion or history of prior reactions to transfusion blood products * females who are identified as donors must not be pregnant
microbiome immunotherapy neoadjuvant assessment

Conditions: Triple Negative Breast Cancer

Summary: predictive biomarkers of response to combination chemotherapy and immune-checkpoint inhibitors are urgently needed to help tailor treatment recommendations for patients with early-stage tnbc. tumour-associated microbiota in primary breast tumours represent promising and novel candidate biomarkers modulators of the efficacy of therapies for patients with tnbc. it has been shown that microbes colonizing breast tumours can modulate the efficacy of commonly used drugs and that the microbiome of breast tissue biopsies could represent a new biomarker. data on the microbiome of patients with cancer indicate the potential for a new class of bacteria-based oncological biomarkers, for exploitation in precision oncology.


Eligibility criteria:
inclusion criteria: 1. be willing and able to provide written informed consent for the trial in accordance with national/local guidelines. 2. be a male or female subject 18 years of age on day of signing informed consent. 3. histologically proven infiltrating carcinoma of the breast on core needle biopsy that is: her2 negative in primary tumour pre-treatment by local pathology assessed according current asco/cap guidelines: in situ hybridization non-amplified (ratio of her2 to cep17 \< 2.0 or single probe average her2 gene copy number \< 4 signals/cell), or immunohistochemistry (ihc) 0 or ihc 1+. er and pr negative in primary tumour pre-treatment defined as \< 10% of cells expressing hormonal receptors via ihc analysis by local laboratory assessment. 4. unresected, untreated breast cancer planned to undergo neoadjuvant systemic therapy, that meets one of the following clinical stages (see appendix a): o t2, t3, or t4a-d lesion, any n, m0 5. be willing to undergo mandatory research biopsy procedure at baseline (up to 4 core samples may be taken from this procedure). exclusion criteria: 1. patients who are pregnant or breast-feeding 2. current use of any investigational agents 3. history or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
evaluation of intravenous dalbavancin for peritonitis

Conditions: Peritonitis; Peritonitis Bacterial

Summary: this study evaluates the use of dalbavancin 1500 mg iv x 1 dose for treating patients with gram positive peritonitis in patients requiring peritoneal dialysis.


Eligibility criteria:
inclusion criteria: patients \> 18 years of age actively receiving peritoneal dialysis diagnosed with a gram + peritonitis determined to be a good candidate for dalbavancin treatment by the attending nephrology attending. exclusion criteria: patients with contraindications to dalbavancin therapy
biopharmaceutical study of glyco pmdi with or without charcoal block vs iv bolus in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled glyco pmdi.


Eligibility criteria:
inclusion criteria: 1. males and females healthy volunteers aged 18-65 years; 2. written informed consent obtained before the first trial related activity. 3. able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly. 4. body mass index (bmi) between 18.0 and 32.0 kg/m2; 5. non- or ex-smokers who smoked \< 5 pack years; 6. good physical and mental status; 7. normal blood pressure and heart rate; 8. electrocardiogram (ecg)considered as normal; 9. results of laboratory tests within the normal ranges. 10. lung function measurements within the normal ranges. exclusion criteria: 1. blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication; 2. pregnant or lactating women or women of childbearing potential, unless they are using one or more of the acceptable methods of contraception. male subjects not willing to use an acceptable method of contraception. 3. positive hiv1 or hiv2 serology; 4. positive results from the hepatitis serology which indicates acute or chronic hepatitis b or hepatitis c; 5. unsuitable veins for repeated venipuncture; 6. history of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening; 7. clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation; 8. clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol; 9. participation in another clinical trial less than 8 weeks prior to inhalation of the study medication; participation in another clinical trial using radioactive material within 1 calendar year; 10. history of hypersensitivity to m3 antagonists or any of the excipients contained in any of the formulations used in the trial; 11. any drug treatment, including prescribed or otc medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital, isoniazid) preceding the first intake of the study drug, with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions). 12. treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole). 13. subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to the first intake of study medication and for the entire duration of the study. 14. heavy caffeine drinker.

Keywords: none (study in healthy volunteers)
the mesenchymal covid-19 trial: mscs in adults with respiratory failure due to covid-19 or another underlying cause

Conditions: Covid19; Acute Respiratory Distress Syndrome

Summary: this is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (iv) administration of cyp-001 in adults admitted to an intensive care unit (icu) with respiratory failure

after enrolment upon meeting eligibility criteria (d0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus cyp-001. on d1 and d3, each participant randomised to receive cyp-001 will receive an iv infusion of 2 million cymerus mesenchymal stem cells (mscs)/kg of body weight (up to a maximum of 200 million cells). participants will have further data collection throughout their icu and hospital stay and follow up to 28 days.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older * respiratory failure with the following signs and symptoms: 1. p/f ratio \<300 mmhg 2. onset within one week of a known insult or new or worsening respiratory symptoms. 3. chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules. * respiratory failure which is not fully explained by cardiac failure or fluid overload. * onset of respiratory failure within the past 48 hours (as defined in inclusion criterion 2 exclusion criteria: * \<18 years of age * patient is known to be pregnant * known active malignancy that required treatment in the last year * who class iii or iv pulmonary hypertension * venous thromboembolism currently receiving anti-coagulation or within the past 3 months * currently receiving extracorporeal life support * severe chronic liver disease (child-pugh score \>12) * "do not attempt resuscitation" order in place * treatment withdrawal imminent within 24 hours * bmi \> 45 kg/m2. * received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned administration of study treatment. * known positive test for human immunodeficiency virus 1 (hiv 1), hiv 2, hepatitis b virus, hepatitis c virus or any other infection which the opinion of the investigator is likely to impact on the ability of the patient to participate in the study. * known sensitivity to dimethylsulfoxide (dmso) or any other component of the study treatment.

Keywords: mesenchymal stem cells msc induced pluripotent stem cells ipsc cellular therapy
one year study to evaluate the safety of the combination of valsartan and amlodipine in patients with hypertension

Conditions: Hypertension

Summary: a one year safety study for patients who complete study vaa489a2201.


Eligibility criteria:
inclusion criteria: * successful completion of vaa489a2201 core trial * visit 7 blood pressure must be msdbp ≤ 95 mmhg and mssbp ≤ 150 mmhg exclusion criteria: * patients who experienced any adverse events considered serious and drug related in vaa489a2201 core * other protocol-defined exclusion criteria may apply

Keywords: hypertension, valsartan, amlodipine,safety
high-concentration nitrous oxide for dental procedural sedation in children

Conditions: Anxiety

Summary: the use of nitrous oxide as a sedative agent is very common in pediatric dentistry. in concentrations up to 50% it is considered as mild sedation and it is very safe. despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as midazolam, atarax or general anesthesia. higher concentration was not conducted in pediatry densitery. the aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

nitrous oxide/oxygen in varying concentrations has been successfully used for many years to provide sedation and analgesia for a variety of painful procedures in children. the use of nitrous oxide as a sedative agent is very common in pediatric dentistry. in concentrations up to 50% it is considered as mild sedation and it is very safe. it is usually used for mild or moderate anxiety state because it is not so potent in concentrations up to 50 %. despite its safety and widespread of its use nitrous oxide is not a potent drug and many times dentists fail to gain cooperation in moderate or high anxious children, and the alternatives are to use moderate sedation with drugs such as midazolam, atarax or general anesthesia. nitrous oxide 50% is the most common concentration in use but the results of the sedation does not always provide a satisfactory cooperation, higher concentration was not conducted in pediatry densitery. the aim of this study is to compare the effectivity and safety of providing nitrous oxide at increasing concentrations 60%, 70% with 50% parameters, sedation depth, adverse events and cooperation of the child during the dental treatment.our hypothesis is that nitrous oxide in concentrations higher than 50% up to 70% is a safe and effective sedation method in dental treatment of children.

Eligibility criteria:
inclusion criteria: * children evaluated by a senior pediatric dentist and require a wide treatment of caries, with a high score of anxiety unable to accept dental treatment with nitrous oxide /oxide of 50% in combined with behavioral management in the pediatric dental clinic. exclusion criteria: * children with high potential risk of sedation, snoring, stridor, sleep apnea, maxillofacial malformation, history of airway difficulty, gastro esophageal reflux, reactive airway disease or acute runny nose, cardiac disease, altered mental status, inadequate fasting time. * parental refusal for conscious sedation.

Keywords: moderate sedation pediatric dentistry anxiety
a study of jnj-95475939 in the treatment of participants with moderate to severe atopic dermatitis (ad)

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate how well jnj-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * chronic atopic dermatitis (ad), according to american academy of dermatology consensus criteria with onset of symptoms at least 1 year prior to the screening visit * eczema area and severity index (easi) score greater than and equal to (\>=) 16 at the screening and baseline visits * validated investigator global assessment for ad (viga-ad) score \>= 3 at the screening and baseline visits * \>= 10% body surface area (bsa) of ad involvement at the screening and baseline visits * baseline peak pruritus numeric(al) rating scale (pp-nrs) average score of \>=4 * documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening) * participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit exclusion criteria: * experienced primary efficacy failure (no response within 16 weeks) or an adverse event (ae) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting il-4rα, il-4, and/or il-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab) * participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study * active skin disease other than ad including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments * current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum * history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers. * diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization * had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
a research study on how semaglutide works in people with fatty liver disease and liver damage

Conditions: Non-alcoholic Steatohepatitis

Summary: semaglutide is a medicine studied in patients with non-alcoholic steatohepatitis (nash), as it may improve liver damage. participants will either get semaglutide or placebo (a dummy medicine) - which treatment participants get is decided by chance. the study will last for about 61 weeks in total. participants will have 10 clinic visits and 3 phone calls with the study doctor or staff during the study. some of the clinic visits may be spread over more days. participants will need to inject themselves with medicine under the skin. participants will have to do this once a week for 48 weeks. the study includes magnetic resonance imaging (mri) scans of the liver, 1 or 2 liver tissue samples, ultrasound scans of the stomach and a possible examination of the food pipe. for some tests participants may need to remove some items of clothing. participants will stop in the study if the doctor thinks that there are any risks for their health. the information collected from participants during the study may help them and other patients with nash in the future. women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. * histologic evidence of nash and fibrosis stage 4 according to the nash crn classification based on central pathologist evaluation of a liver biopsy obtained within 360 days prior to screening. in subjects who have never had a liver biopsy showing nash and f4, liver stiffness above 14 kpa by fibroscan® at screening must be documented before subjects can have a trial-related liver biopsy * a histological nafld activity score (nas) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation * body mass index equal to or above 27 kg/m\^2 exclusion criteria: * presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation * presence or history of gastroesophageal varices within the past 360 days prior to screening. for subjects with no known history of gastroesophageal varices and with a fibroscan® equal to or above 20 kpa and thrombocytes equal to or below 150,000, a esophagogastroduodenoscopy must be performed to evaluate presence of gastroesophageal varices * presence or history of hepatocellular carcinoma * treatment with vitamin e (at doses equal to or above 800 iu/day) or pioglitazone which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to screening * treatment with glucagon-like peptide-1 receptor agonists (glp-1 ras) in the period from 90 days prior to screening * treatment with other glucose lowering agent(s) (apart from what is listed in the exclusion criterion above) or weight loss medication not stable in the opinion of the investigator in the period from 28 days prior to screening