Kornimate/medical-research-clean huggingface dataset:
protective immunity project 02

Conditions: Kidney Transplant; Immunology; Immunosuppression

Summary: influenza (flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. the influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus. previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. in this study, we hope to evaluate these differences in more detail. in recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system. we hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or cni, and sirolimus-based regimens) on immune response to flu vaccine. such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 18 and 59 years of age 2. greater than six months post deceased or living donor renal transplant 3. patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study. 4. patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (wbc \< 2500 cells/ml) 5. women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding. exclusion criteria: 1. patients with evidence of an active systemic infection

Keywords: transplant immunology immunosuppression
comparison between two total knee prosthesis medacta gmk sphere and medacta gmk ps

Conditions: Knee Osteoarthritis

Summary: the purpose of the study is to compare the clinical outcome after two total knee endoprosthesis designs medacta gmk sphere and medacta gmk ps. primary outcome measures koos, forgotten knee score and range of motion. single-center, randomized trial

the clinical outcome measures were measured preoperativ and postoperativ (1 year, 5 year and 10 year). secondary outcome measures: number of reoperations and revisions, survival of the prosthesis the patient population would consist patients with knee osteoarthritis eligible for total knee replacement the aim of the study is to evaluate the effect of the knee prosthesis design on the patient outcome

Eligibility criteria:
inclusion criteria: * patient is eligible for a total knee replacement * patient is eligible for a medacta gmk sphere or medacta gmk ps knee prosthesis * patient signed the informed consent exclusion criteria: * patient is pregnant
effect of liraglutide on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa) and canada. this trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treated with oral anti-diabetic (oad) drugs for at least 3 months * treated with one or more oad and in moderate to poor glycemic control * body mass index (bmi) less than or equal to 45.0 kg/m2 exclusion criteria: * treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the investigator * any serious medical condition * treatment with any drug that could interfere with glucose level
the effect of pranayama breathing technique on asthma control, pulmonary function and quality of life

Conditions: Asthma

Summary: most of the asthma patients prefer complementary and integrative applications as they continue to experience asthma symptoms despite pharmacological treatment. pranayama, one of these treatments, is a breathing-based technique and is a part of yoga, an ancient indian science. this study was carried out as randomized controlled single blind study in order to analyze the effect of pranayama breathing technique applied to individuals suffering from asthma on asthma control, pulmonary functions and quality of life. the study comprised 50 patients in total, as 25 patients in pranayama group and 25 patients in control group. the approval of ethics committee, permissions from the institutions, and informed voluntary approval of the individuals were obtained to conduct the research. the data of the research were collected through the application of asthma control test (act), asthma quality of life questionnaire (aqlq), pulmonary function test (pft), and patient observation chart. pranayama breathing technique was applied to pranayama group 20 minutes once a day for four weeks, and relaxation technique was applied to relaxation group similarly in addition to standard treatment. act, aqlq, and pft were evaluated twice as before and after the one month of application process. meanwhile, the patients' pef measurements were followed with individual pef meter on daily basis. the value of p\<0.05 was accepted statistically significant in the data analyses.


Eligibility criteria:
inclusion criteria: * can communicate, * to have an increase of %12 or 200 ml in fev1 value after inhaler bronchodilator at breathing function test, * to have chronic asthma diagnose with 6 months approved by doctors and receiving treatment, * asthma controls are not under control or partly under control in relation to gina (global initiative for asthma) values, * taking beta2-agonist and/or ics twice a week or more to control asthma symptoms, * there is not any chance in inhaler bronchodilator drug potions during the last four weeks, * can use a smart phone. exclusion criteria: * to have lung diseases such as copd, * to have tuberculosis and respiratory infection, * to have diabetes and coronary artery disease, * smokers * pregnant or nursing mother, * doing regular exercise, * benefitng from other complementary and integrative health applications during treatments

Keywords: asthma yoga breathing exercises quality of life nursing
functional recovery and caregiver burden following surgery in the elderly

Conditions: Activities of Daily Living; Caregivers; Ambulatory Surgical Procedures

Summary: the purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. this study will provide unique insight into the challenges patients and their families face following surgery. the primary objective of this study is to: 1. assess the impact of ambulatory surgery on functional capacity as assessed by the système de mesure de l'autonomie fonctionnelle (smaf) one week and one month following surgery in a population of surgical patients 65 years of age and older. secondary objectives are to determine if: 2. changes in the patient's functional capacity result in increased burden of care as assessed by the zarit burden interview (zbi) in the patient's primary caregiver. 3. changes in functional capacity are correlated with decrements in quality of life as assessed by the short form 12 (sf12). 4. changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the brief pain inventory (bpi).


Eligibility criteria:
inclusion criteria: patients * aged 65 years and older * elective surgery with a planned discharge to the community on the day of the surgical procedure. * eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy. caregiver - spouses, family members, or friends identified as the patient's primary source of support in the community. exclusion criteria: patients * reside in a nursing home providing professional support services; * are unable to complete the study instruments due to cognitive (mmse \<24) or physical impairment; * are unable to speak english or french caregiver * professional caregivers (nurse, personal care assistant, etc) hired to care for the patient; * unable to complete the study instruments due to physical impairment; * unable to speak english or french

Keywords: activities of daily living caregivers ambulatory surgical procedures
evaluation of the benefits of individualized advice administration on quality of sleep for the elderly living at home

Conditions: Sleep Disorder; Complaint, Subjective Health

Summary: sleep disorder is often a complaint from the older people. prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. sleep physiologically changes with aging. sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse...), or some medical treatments. regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes. various studies have proved the major role of sleep on health and wellbeing. sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. according to the french high health authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders. results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. this work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. patients with a moderate cognitive impairment who have a caregiver at home can also join the study. the main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the pittsburgh sleep quality index which validity was demonstrated among the elderly.


Eligibility criteria:
inclusion criteria: 1. patient giving a signed informed consent 2. patient complaining about their sleep 3. patient living at home 4. patient with a mini mental state examination score of 10 or more if the mini mental state examination score is between 10 and 20, caregiver living at home able and willing to be in charge of a sleep calendar 5. patient able to fill in questionnaires exclusion criteria: 1. patient living in a senior living facility 2. patient legally protected 3. patient with a psychotic decompensation 4. patient with a sleep pathology 5. patient with a lewy body disease at the time of enrollment 6. patient with no health insurance

Keywords: quality of sleep elderly health education quantity of sleep caregiver's burden
blood and tissue markers for improving diagnosis and prognosis of endometriosis. (endobio)

Conditions: Endometriosis

Summary: endometriosis is a chronic, benign, estrogen-dependent disease characterized by endometrial tissue that is implanted outside the uterus into the ovaries, intestines, or peritoneum but also outside the pelvis. it is a common disease that affects 7-10% of women around the world. the most common symptoms are pain and infertility. the diagnosis is histological after removal of lesions with laparoscopy (sensitivity 94%, specificity 79%), and treatment is symptomatic. at present, there is not a laboratory test that allows early and adequate diagnosis of endometriosis and therefore it can take up to 10 years for a patient to be diagnosed and patients often suffer from the disease. the purpose of our study is to investigate biomarkers associated with endometriosis and prove their use in the diagnosis and staging of endometriosis. the biomarkers will be studied even in relationship to clinical manifestations of the disease, as markers of relapse and as fertility markers. meanwhile, quality of life of patients with advanced stages of endometriosis postoperatively will be studied.


Eligibility criteria:
iinclusion criteria: * women of reproductive age (18-45) who are operated because of suspected endometriosis (dysmenorrhea, dyspareunia, infertility, etc.) (patient group) * women of reproductive age (18-45) who are operated for other benign gynecological causes with laparoscopy (ovarian cysts, sterilization, fibroids, etc.) and are found without macroscopic endometriosis perioperatively and confirmed with blind biopsies (control group * talk swedish or english in order to complete questionnaires and give informed consent for their participation in the study. exclusion criteria: * bmi\> 40 * postmenopausal women * premature ovarian failure * pelvic inflammatory disease (pid) * current or previous malignancy * pregnancy and 6 months postpartum * corticosteroids in the last 3 months * pituitary, kidney, liver, adrenal disease * endometrial hyperplasia or endometrial polyp * cardiovascular or systemic inflammatory diseases.

Keywords: endometriosis biomarkers
naldebain for postoperative pain management in take down of anastomosis

Conditions: Postoperative Pain

Summary: naldebain er injection, invented by taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. it was approved for the premedication use for moderate to severe pain relief, expected after surgery. there was limited experience with the combination of medication and different type of surgeries. only the effect of operative analgesia on the hemorrhoidectomy patients have been well studied. through reviewing the past medical cases, the pain intensity after receiving take down of anastomosis was about 4 to 7 points (moderate pain), lasing about 1 to 3 days. it was a suitable population with multi-day analgesic unmet need. at present, the standard treatment after take down of anastomosis in the cmuh was morphine as needed. this treatment might not provide for well-controlled postoperative pain management. patients might receive more painkillers when they needed than before pain occurred. plus, it also cost more postoperative medical care. therefore, this study intended to compare the standard treatment and naldebain for postoperative outcomes, safety and satisfaction. the study will enroll patients scheduled to electively undergo take down of anastomosis. eligible subjects were randomly divided into two groups, one receiving naldebain and the other receiving standard treatment. the study will evaluate pain intensity, dosage of supplement analgesics, incidence of adverse reactions, patient satisfaction, time of the first fart after surgery, and duration of postoperative hospital stay.

this is an open-labeled, randomized clinical trial. after icfs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. and then, on day -1, eligible ones will randomly be divide into two separate group: naldebain or morphine. group naldebain will receive nadebain by gluteus maximus injection between 12 and 24 hours prior to surgery for postoperative pain relief. group morphine will receive morphine as needed after surgery. all necessary data will be gain form emr or patient dairies.

Eligibility criteria:
inclusion criteria: 1. men and women between 20 and 80 years of age 2. history of laparoscopic surgery 3. american society of anesthesiology physical class 1-3 4. ability and willingness to provide informed consent exclusion criteria: 1. history of hypersensitivity or allergy to opioid, nsaids, or acetaminophen 2. chronic preoperative opioid use 3. severe comorbidity which is able to interfere pain assessment 4. ostomy surgery of intestine within the past 8 weeks 5. pregnant or breastfeeding

Keywords: naldebain long-term analgesia take down of anastomosis
synchrony and reciprocity of body movements and prosody between psychotherapist and patient

Conditions: Relationship, Professional Patient

Summary: modern psychotherapy focuses on co-regulation, where therapist and patient interactively manage emotions. this co-regulation is seen in nonverbal communication like facial expressions, gestures, and prosody (vocal pitchs). studies show body movements and even skin conductance synchronize between patients and therapists during sessions. the reciprosody project builds on this by using technology (cameras, sensors) to record and analyze these synchronies in psychotherapy sessions. this project aims to understand how this "attunement" between therapist and patient contributes to successful therapy. researchers will explore how patients and therapists interact using a mobile app that records video, audio, physiological signals (heart rate), and movements. questionnaires will assess patient well-being and therapist experience. by studying these micro-processes, reciprosody hopes to gain insights into how the therapeutic relationship develops, including the connections between physical reactions, nonverbal communication, and overall progress. this knowledge can improve psychotherapeutic techniques and highlight the importance of the nonverbal communication in therapy.


Eligibility criteria:
inclusion criteria: * male and female adults between the ages of 20 and 60 years old who are referred to the hcc italy clinical and psychotherapy research center exclusion criteria: * patients under 20 years of age * presence of paranoid or psychotic symptoms * admissions to psychiatric operative units that have occurred within the last year since the start of psychotherapy at the hcc italy clinical and psychotherapy research center

Keywords: psychotherapy facial mimicry fidgeting relational synchrony
triage - symptoms and other predictors in an all-comer emergency department population; (ekbb 236/13)

Conditions: Triage Risk Stratification

Summary: this study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. based on vital signs, impaired mobility on presentation (imop), clinical frailty scale (cfs) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established.

most emergency departments (eds) perform an initial risk stratification of patients, called triage. establishing a diagnosis is key for the administration of the appropriate treatment and the following disposition decision. the earlier and the more accurate the final diagnosis is established, the shorter the time to treatment and time to disposition, and thus, the more efficient the patient flow. new ways to improve diagnosis accuracy early on in patients' ed visits are needed. although a great number of well validated and widely used triage systems exists, to this date no gold standard in triage risk stratification has been established. most of the existing triage systems rely on the measurement of vital signs and a list of chief complaints. this study is to develop a tool capable of improved risk prediction regarding the 30-day mortality. based on vital signs, impaired mobility on presentation (imop), clinical frailty scale (cfs) and patients' symptomatology three risk categories (low, intermediate, high risk) will be established. according to acuity patients undergo triage or directly proceed to the treatment unit. patients awaiting triage will be approached by a member of the study personnel and will be verbally informed about the study. afterwards, patients will be interviewed asking about their symptoms and their reason for presentation. patients in need of immediate therapy will receive therapy before start of the interview. following the interview, patients undergo routine triage.the physician performing initial triage will be asked to rate how ill patients appear to be using a numeric scale ranging from 0 (perfect condition) to 10 (extremely ill). treating physician's will be asked to state their suspected diagnosis as well as differential diagnoses. follow-up to assess 30-day and 1-year mortality rate and date of death will start one year after the end of the inclusion period.

Eligibility criteria:
inclusion criteria: * patients presenting to the ed of the university hospital basel and awaiting triage exclusion criteria: * unwillingness to participate * insufficient ability to communicate with the study personnel.

Keywords: risk prediction electronic triage systems (ets) undertriage overtriage
a study on the safety and immunogenicity of influenza, respiratory syncytial virus, human metapneumovirus and parainfluenza vaccines in adults 18 to 49 years of age.

Conditions: Healthy Volunteers; Influenza Vaccination; Respiratory Syncytial Virus Vaccination; Parainfluenza Vaccination; Human Metapneumovirus Vaccination

Summary: the objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. a lipid nanoparticle will be used in this study. overall, the study is designed to: * assess the safety profile of the candidate formulations * describe the immunogenicity profile of the candidate formulations * eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations. participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited adverse events (aes), serious adverse events (saes) and adverse events of special interest aesis). participants will also be required to record their daily temperature on the diary.

the duration of study participation will be approximately 6 months for each participant.

Eligibility criteria:
inclusion criteria: * aged 18 to 49 years on the day of inclusion * a female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * is of non-childbearing potential. to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile or * is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration. exclusion criteria: - any medical condition or circumstance which, in the opinion of the investigator, might interfere with the evaluation of the study objectives note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: influenza respiratory syncytial virus parainfluenza human metapneumovirus