Kornimate/medical-research-clean huggingface dataset:
a study of ustekinumab or guselkumab in pediatric participants with active juvenile psoriatic arthritis

Conditions: Arthritis, Juvenile

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jpsa).


Eligibility criteria:
inclusion criteria: * diagnosis of juvenile psoriatic arthritis (jpsa) by vancouver criteria with exclusion of enthesitis-related arthritis (era). diagnosis made \>=3 months (that is, 90 days) prior to screening * active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. swelling alone meets the criteria for an active arthritic joint. in the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint * have active disease despite previous non-biologic disease modifying anti-rheumatic drug (dmard) and/or non-steroidal anti-inflammatory drug (nsaid) therapy: non-biologic dmard therapy is defined as taking a non-biologic dmard for at least 12 weeks or evidence of intolerance; nsaid therapy is defined as taking an nsaid for at least 4 weeks or evidence of intolerance * concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or nsaids is permitted but must be on stable dose * participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients * prior use of anti-tnfα agents, il-17 inhibitors and other biologics (except non-responders to il-23 inhibitors) and jak inhibitors are permitted with sufficient washout period exclusion criteria: * participants with enthesitis-related arthritis (era) * have a history of latent or active granulomatous infection, including tuberculosis (tb), histoplasmosis, or coccidioidomycosis prior to screening * have a history of, or ongoing, chronic or recurrent infectious disease * has evidence of herpes zoster infection within 8 weeks prior to week 0 * have a known history of hepatitis c infection or test positive at screening
patient-reported outcomes in head and neck cancer

Conditions: Head and Neck Cancer; Radiotherapy Side Effect

Summary: weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer. the study is a national study under the danish head and neck cancer group (dahanca) and all 6 centers in denmark will participate. the clinical endpoints will be: * quality of life * objective toxicity score (dahanca) * opioid treatment * tube feeding * weight loss * hospitalization * compliance to treatment

there is a high level of evidence for improved disease control in head and neck cancer (hnc) using regimens with accelerated radiotherapy and concomitant chemotherapy. these intense regimens can result in severe acute and late side effect. the standard approach for documenting symptomatic adverse events (aes) in cancer clinical trials involves investigator reporting using the national cancer institute's (nci's) common terminology criteria for adverse events (ctcae). in denmark, the danish head and neck cancer group (dahanca) toxicity score has been used as an instrument in assessing objective treatment induced toxicity. new research in other cancer treatments indicate, that systematic patient assessment of side effects may improve treatment outcome. patient reported outcomes (pros) can be used for symptom monitoring. interactive use of pro may secure early recognition of specific symptoms in the individual patient and timely management of side effects. this trial it is a prospective nationwide, single armed sequential cohort study will investigate the effects of active use of pros in clinical counselling and decision making during primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck (hnscc). it will investigate quality of life and the management of side effects in standard clinical counselling (control group) versus standard clinical counselling plus the pro (pro group). the eortc qlq-c30 (quality of life questionnaire) and eq-d5-l5 will be answered in both groups. in the pro group the participants will be asked to complete the electronic pro (pro ctcae™ hnc relevant items supplemented by hnc specific items fra the eortc library) weekly. the electronic pro questionnaire is designed to give feedback to treating physician and nurses at visits during and shortly after radiotherapy.

Eligibility criteria:
inclusion criteria: * primary or post-operative curative radiotherapy (photons) plus/minus concomitant cisplatinum for squamous-cell carcinoma of the head and neck (hnscc) * no serious cognitive deficits * read and understand danish exclusion criteria: •prior radiotherapy in the same area (head and neck)

Keywords: patient-reported outcome quality of life electronic reporting of symptoms radiotherapy
early percutaneous cryoablation for pain control after rib fractures among elderly patients

Conditions: Rib Fractures

Summary: the purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity

the purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and return them to baseline functional capacity. in order to do this, we would offer a minimally invasive solution known as cryoneurolysis. by directly applying cold cryoneurolysis to the nerves, this can destroy nerve axons, resulting in wallerian degeneration of the distal nerve without distorting epineural or perineurial tissue. the application of cryoneurolysis will help reduce the amount of narcotics the patient would need, and potentially lead to a better post-injury quality of life.

Eligibility criteria:
inclusion criteria: i) patients greater than 65 years with any acute rib fracture ii) pain score equal to or greater than 5 with deep inspiration. iii) presenting and admitted to stanford emergency department exclusion criteria: i) radiographic evidence of metastasis to ribs ii) glasgow coma scale (gcs) score \<13 iii) patients undergoing ssrf iv) rib fractures located \< 3cm from spinous process v) coagulopathy (inr \>1.5, pat \< 100) vi) other factors precluding cryoablation at ir attending's discretion vii) if only ribs broken are 1,2 or 10,11, 12
darunavir/cobicistat vs. lopinavir/ritonavir in covid-19 pneumonia in qatar

Conditions: Coronavirus; COVID; Pneumonia

Summary: coronavirus disease 2019 (covid-19) is a disease caused by the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) virus. it was first isolated in wuhan, china in december 2019 and then rapidly spread to the rest of the world posing a severe threat to global health. many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes. protease inhibitors are one of the proposed agents, but their use is limited to their significant drug interactions and side effects. the aim of this study is to compare the efficacy and safety outcomes of darunavir/cobicistat versus lopinavir /ritonavir in the treatment of patients with covid-19 pneumonia in qatar.


Eligibility criteria:
inclusion criteria: * adult patients ≥18 years of age * laboratory confirmed 2019-ncov infection as determined by the pcr of the nasopharyngeal/oropharyngeal swab. * radiologically confirmed pneumonia (based on the chest x-ray or ct scan imaging). * have received either darunavir/cobicistat or lopinavir/ritonavir as part of the treatment regimen for covid-19 pneumonia exclusion criteria: * no exclusion criteria will be applied
clinical performance and quality measures for adults with acute st-elevation myocardial infarction in china

Conditions: ST Elevation Myocardial Infarction

Summary: this study aims to investigate and evaluate clinical performance and quality measures for adults with acute st-elevation myocardial infarction (stemi) in china. further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with stemi. this is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and team building will be organized for the purpose of quality improvement. all hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. then the reperfusion rates and other performance measures will be compared annually.

cardiovascular disease (cvd) is a major concern in public health globally, as well as in china, and remarkable variations of resources available and health system performance have been noted. acute myocardial infarction is one of the leading causes of mortality and morbidity, both in rural and urban area. this study aims to investigate and evaluate clinical performance and quality measures for adults with acute st-elevation myocardial infarction (stemi) in china. further more, the investigates like to develop quality improvement strategies and relevant tools focusing on treatment and clinical outcome in patients with stemi. this is a annually survey , through consecutively recruiting all eligible inpatients and collecting relevant medical information, the performance of all participating hospitals. demographic characteristics, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be obtained and then, the treatment pattern and outcomes will be evaluated. further, quality improvement strategies including summary of clinical performance and quality measures, clinical pathways and professional training will be organized for the purpose of quality improvement. all hospitals will consecutively recruit qualified patients in the same method adopted in baseline period. then the reperfusion rates and other performance measures will be compared annually. new knowledge will be generated about stemi management in china, to improve stemi patients prognosis in future.

Eligibility criteria:
inclusion criteria: * patients with stemi who arrive at the hospital within 48 hours from the symptoms onset. exclusion criteria: * none

Keywords: clinical performance quality measures st-elevation myocardial infarction
neuropeptides in human reproduction

Conditions: Hypogonadotropic Hypogonadism

Summary: the investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. dynorphin is a naturally occurring opioid hormone that is blocked by naloxone. we hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (gnrh) and kisspeptin, two other naturally occurring reproductive hormones.


Eligibility criteria:
inclusion criteria: * ages 21-40 (healthy men and regularly cycling women) or ages 18-75 (men and women with hypogonadotropic hypogonadism (hh)) * normal blood pressure (systolic bp \<140 mm hg, diastolic bp \<90 mm hg) * white blood cell, platelets, prolactin, and thyroid stimulating hormone (tsh)within 90%-110% of laboratory reference range * negative urine drug screen panel * hemoglobin: 1. for healthy men and healthy regularly cycling women: normal 2. for men and women with hh: no less than 0.5 gm/dl below the lower limit of the reference range for normal women * blood urea nitrogen (bun), creatinine, liver function tests not elevated * for healthy subjects: normal reproductive function and history * for healthy subjects: body mass index (bmi) 18.5-30kg/m2 * for subjects with hh: all medical conditions stable and well controlled exclusion criteria: * history of medication reaction requiring emergency medical attention * illicit drug use * consumption of more than 10 alcoholic drinks per week * difficulty with blood draws * currently seeking fertility, breastfeeding, or pregnant * for healthy subjects: history of chronic disease and prescription medication use (with the exception of seasonal allergy medication) * for subjects with hh: prescription medications known to affect reproductive endocrine function except for those used to treat the subject's reproductive condition

Keywords: reproductive disorders hypogonadotropic hypogonadism kisspeptin gnrh naloxone
rfa for small hcc with no-touch technique using octopus electrode

Conditions: Carcinoma, Hepatocellular

Summary: in this study, the investigators are going to prospectively compare the clinical outcomes (technical success rate, 12 month local tumor progression rate, complication rate, tumor seeding rate) of radiofrequency ablation (rfa) with octopus electrode and no-touch technique for hepatocellular carcinoma (hcc) to those of rfa with conventional tumor puncture method with the same device.


Eligibility criteria:
inclusion criteria: * child-pugh class a * patient with 1cm-2.5cm sized hcc * 1 or 2 hccs * being referred for curative purpose of rfa * sign informed consent exclusion criteria: * maximum tumor diameter greater than 2.5cm * child-pugh class b or c * more than 3 hcc lesions * invisible tumor even after us/ct or us/mr fusion * presence of vascular tumor thrombosis or extrahepatic metastasis * severe coagulopathy (plt \< 50k, pt \< 50% of normal range)

Keywords: hcc rfa
optimizing the ambiance during mealtimes in dutch nursing homes

Conditions: Malnutrition

Summary: optimizing the social and physical ambiance during mealtimes in dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.

study design: during six months the intervention group had their meals in family style, and the control group received the usual tray services. hypothesis: we hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group. site and participants: nursing homes volunteered to participate in the study. in each nursing home there was a control and intervention ward. only residents with a chronic somatic disorder were included. residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. the ethical committee and the client board of the nursing homes and the medical ethical committee of wageningen university approved the study protocol. intervention: the intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the netherlands. the program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. before the start of the meal, tables were set with tablecloths, full cutlery and plates. the cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.

Eligibility criteria:
inclusion criteria: * nursing home residents with a chronic somatic disease and long term care exclusion criteria: * residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.

Keywords: family style dinner quality of life nutritional status nursing home residents
a comparison of two ultra-brief interventions in primary care for patients with anxiety, depression, and stress.

Conditions: Mental Disorder; Mental Health Issue; Mental Depression; Anxiety; Mental Stress; Rumination - Thoughts

Summary: the goal of this clinical trial is to compare the effect and time consumption of the swedish translation of the protocol for rnt-act with the internet administrated self-help treatment with therapist support (icbt) for patients seeking medical care for depression, anxiety or stress at their primary care unit. the trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.

the main question it aims to answer are: is the swedish translation of a psychological treatment protocol targeting repetitive negative thinking (rnt) based on acceptance and commitment therapy (act), rnt-act, an effective treatment in swedish primary care for the treatment of people with a high proportion of negative repetitive thoughts, who meet diagnostic criteria for depression and/or anxiety? the question is planned to be elaborated into the following parts: a feasibility study in which the material and the system are tested at a single care center. a randomized controlled trial conducted at several health centers where the comparison group is patients who are actualized for traditional psychological treatment in the form of icbt for either anxiety or depression programs and where they are offered the second treatment arm after 3- and 12-month follow-ups. a follow-up study where time consumption and patient satisfaction are evaluated in both branches. participants will be given either rnt-act or icbt as treatment. the group who are given rnt-act will receive 2\*60 minutes of therapy along with mindfulness files to listen to daily between sessions. the group who are given icbt will receive internet-based cognitive behavioral therapy, one of the forms of delivering cognitive behavioral therapy that is implemented in region skåne and can thus be seen as treatment as usual. patients will access the treatment through a secure website and communicate with their therapist by text when needed. researchers will compare the rnt-act and icbt groups to see if there are differences in depressive, anxiety- and stress- related symptoms, rumination, psychological flexibility, client satisfaction and therapist-rated time consumption. in the feasibility study researchers will also evaluate drop-out and recruitment rate.

Eligibility criteria:
inclusion criteria: * dass-21 \>25 * ability to communicate in swedish orally and in writing exclusion criteria: * routine blood tests are carried out including blood count, thyroid hormone, liver status and fluid balance in order to be able to differentially diagnose any physical illness. in addition to physical illness are exclusion criteria * other psychological or psychiatric treatment, * suicidality, substance abuse, anorexia nervosa, psychosis, bipolar disorder, attention deficit hyperactivity disorder (adhd) and antisocial personality disorder (as verified based on m.i.n.i 7.0).
a randomized, open-label, multi-center phase iii study comparing the efficacy of oral chemotherapy combined with trastuzumab versus paclitaxel combined with trastuzumab in the adjuvant treatment of her2-positive, lymph node-negative early breast cancer patients(orchid-plus)

Conditions: HER2-positive Breast Cancer

Summary: although there is a certain risk of recurrence of her2-positive small tumors, the overall prognosis is relatively good. in order to further reduce the toxicity and side effects of treatment and explore the best strategy for adjuvant therapy in patients with her2-positive stage ia breast cancer, we designed this phase iii, randomized, open-label study to evaluate the efficacy and safety of paclitaxel plus trastuzumab and capecitabine versus paclitaxel plus trastuzumab in the adjuvant treatment of patients with her2-positive, node-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. females aged 18\~70; 2. the postoperative pathological stage of early breast cancer is stage ia: the longest diameter of invasive cancer is not more than 2cm and the lymph node is negative: pt1mic-t1cn0m0 (micro-invasion needs to meet multiple foci). 3. pathological immunohistochemistry must meet the following conditions: her-2 (3) or her-2 (0-2) but amplified by fish or cish testing. 4. the maximum number of weeks (56 days) from surgery to randomization is not more than 8 weeks (56 days). 5. the function of major organs is normal, that is, the following criteria are met: (1) the criteria for routine blood examination must meet: hb ≥90 g/l (no blood transfusion within 14 days); anc ≥1.5×109 /l； plt ≥100×109 /l； (2) biochemical tests must meet the following standards: tbil ≤1.5×uln (upper limit of normal value); alt and ast ≤3×uln; serum cr ≤1×uln, endogenous creatinine clearance \>50 ml/min (cockcroft-gault formula); 6. cardiac function: ecg was generally normal, qtc \ 50%; 7. the subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up exclusion criteria: 1. patients who have received neoadjuvant therapy, including chemotherapy, targeted, radiotherapy, or endocrine therapy; 2. history of other malignant tumors in the past, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. metastasis of any site; 4. pregnant or lactating women, women of childbearing age who cannot use effective contraception; 5. patients who are also participating in other clinical trials; 6. severe organ function (heart, lung, liver, kidney) insufficiency, levf \ 150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months before enrollment; diabetic patients with poor glycemic control; patients with severe hypertension; 7. severe or uncontrolled infection; 8. those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorder; 9. patients who are judged by the investigator to be unsuitable to participate in this study.
peak bronchoprotection conferred by levosalbutamol and racemic salbutamol

Conditions: Asthma

Summary: the objective of this study is to compare the peak dose relative bronchoprotection offered by levosalbutamol and racemic salbutamol in mild to moderate asthmatics preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms.


Eligibility criteria:
inclusion criteria: 1. mild to moderate stable asthmatics on ≤ 2000μg bdp or equivalent 2. methacholine responsive pc20\< 4 mg/ml 3. \>1dd change in methacholine pc20 after the administration of racemic salbutamol. 4. male or female 18-65 5. informed consent 6. ability to comply with the requirements of the protocol exclusion criteria: 1. severe asthmatics as defined by an fev1≤ 60% or pef variability \> 30% or with continual daytime or nocturnal symptoms. 2. the use of oral corticosteroids within the last 3 months. 3. recent respiratory tract infection (2 months). 4. significant concomitant respiratory disease such as copd, cf, abpa, bronchiectasis and active pulmonary tuberculosis. 5. any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent tia/ cva,that may endanger the health or safety of the participant, or jeopardise the protocol. 6. any significant abnormal laboratory result as deemed by the investigators 7. pregnancy, planned pregnancy or lactation 8. known or suspected contra-indication to any of the imp's 9. concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

Keywords: asthma levosalbutamol genotype bronchoprotection