Kornimate/medical-research-clean huggingface dataset:
a study to assess the abuse potential of intranasal cebranopadol

Conditions: Abuse, Drug

Summary: the purpose of this study to assess the abuse potential of intranasal cebranopadol compared to oxycodone and placebo in healthy, nondependent recreational opioid users.

this study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone hcl ir and placebo in recreational opioid users with intranasal experience, a dose escalation phase (part a) will first be conducted to determine a safe dose for evaluation in the main study (part b). the dose selection phase (part a) will consist of 3 phases: screening, treatment and follow-up. subjects will participate in an outpatient medical screening visit, a 4-day treatment visit and a follow-up phone call. the main study (part b) will consist of 4 phases: screening, qualification, treatment and follow-up. subjects will participate in an outpatient screening visit, a 4-day qualification phase, a 30-day treatment phase and a follow-up phone call.

Eligibility criteria:
key inclusion criteria: * experienced opioid user who meets the following criteria: (1) has used opioids for nontherapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions in the year prior to screening; (2) has used opioids at least once in the 12 weeks prior to screening; and (3) self-reported intranasal use of drugs of abuse on at least 3 occasions in the year prior to screening. * subjects must be in good health as determined by medical history, physical examination, 12-lead ecg and vital signs measures (pulse rate, systolic and diastolic blood pressure, respiratory rate and oxygen saturation using pulse oximetry) at screening. * subjects must be willing to comply with the requirements and restrictions of the study. key exclusion criteria: * drug or alcohol dependence in the 12 months prior to screening (except nicotine), as defined by the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine). * subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation). * history or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal or other disease at screening, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results. * clinically significant abnormalities in the intranasal cavity (including a deviated septum, perforated nasal septum, rhinorrhea, or excessive sneezing) or any condition that, in the opinion of the investigator, would interfere with the study procedures, data integrity or would compromise the safety of the subject. subjects with nasal piercings/nose rings will be required to remove them for the duration of their inpatient stay.

Keywords: human abuse potential
analyst & brugada syndrome - feasibility study

Conditions: Brugada Syndrome

Summary: brugada syndrome is characterized by a st shift on the surface ecg, and a specific morphology of the twave. this ecg abnormality is called a type 1-ecg, and is variable in time. patients presenting a brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. it is suspected that the type 1-ecg burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ecg over a long period of time. the objective of the study is to evaluate the correlation between st elevation on the electrocardiogram (ecg) and st shift on the intracardiac electrograms (egm) recorded with the analyst icd, to assess the ability of the device to detect the type 1-ecg. patients enrolled in the study are patients already implanted with a defibrillator for their brugada syndrome. during an ajmalin test, which unmasks the type 1-ecg, both intracardiac egm and surface ecg will be compared to assess the detection of the typical st-shift by the icd.

to evaluate the correlation between st elevation on the ecg and st shift on the intracardiac egm recorded with the analyst icd, patients enrolled will have to be already diagnosed as presenting the brugada syndrome. they will undergo an ajmaline test, to unmask the type 1-ecg, characteristic from the brugada syndrome.during the test, both surface ecg and intracardiac signal will be continuously recorded; then the signals will be compared in terms of amplitude of the st shift, duration of the shift, and recovery period.

Eligibility criteria:
inclusion criteria: * patients with brugada syndrome and previous positive ajmalin test
re-irradiation of progressive or recurrent dipg

Conditions: Recurrent or Progressive Diffuse Intrinsic Pontine Glioma

Summary: this is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (dipg)

study therapy will consist of radiation therapy (rt) given over 17 treatment days (for 30.6 gy in fractions of 1.8 gy) or 20 treatment days (for 36 gy in 1.8 gy fractions), depending on the time from completion of the first course of rt. treatment days will generally be weekdays, not including statutory holidays.

Eligibility criteria:
inclusion criteria: all of these criteria must be met for a patient to be eligible for this study: 1. each site may accept a patient on study of any age that they have permission to treat and follow on study per their institutional policy. 2. the patient has no evidence of metastases on cranial or spinal mr imaging 3. the patient has received rt in the past, given to a total cumulative dose of \<60 gy; prior radiation using opposed lateral fields, conformal 3-d fields, imrt or using protons is acceptable 4. at least 180 days have elapsed from the last day of primary rt for dipg 5. the patient has recovered from all acute and subacute toxicities of prior rt and of chemotherapy, if chemotherapy was utilized in the past 6. the patient has been off all anti-tumour therapy for at least 14 days 7. the patient has a lansky score of 40% or higher 8. the patient has a life expectancy anticipated to be at least 8 weeks with treatment using re-irradiation, with or without dexamethasone 9. the patient has no uncontrolled medical condition (e.g., seizures, diabetes, infection) that would interfere with the delivery of rrt 10. the patient agrees to not enroll on any other clinical trial of an anti-tumour intervention 11. the patient agrees to report and have recorded the use of all medications taken during rerad therapy, from the time of diagnosis of progression or recurrence, then through and after completion of, rerad therapy; this includes the use of complementary, alternative and dietary therapies 12. the patient is treated at a site where the study is approved by the local ethics board 13. males and females of child-bearing potential must agree to use effective birth control measures during rrt 14. consent, and, if applicable, assent, has been obtained according to institutional standards exclusion criteria: if the patient fulfills any of these criteria, then he or she will not be eligible for the study: 1. females who are pregnant, due to risks from rrt on the developing fetus. 2. any patient with a condition that prohibits the planned delivery of rrt as prescribed in this study. 3. patients who are receiving any other clinical trial of an anti-tumour intervention
the correlation between ovarian function and serum biomarkers

Conditions: Premature Ovarian Insufficiency; Diminished Ovarian Reserve; Biomarker; Copper; Ceruloplasmin; Aging

Summary: the goal of this observational study is to find differences in serum biomarkers between ovarian function and normal individuals.

collect the serum of the observation group and control group volunteers, and measure the levels of copper ions, iron ions, ceruloplasmin (cp), cuzn sod, malondialdehyde (mda), etc. in the serum.

Eligibility criteria:
inclusion criteria: 1. the selection criteria for healthy individuals are follows. * women aged 18-45. * basic fsh\<10iu/l, and amh is within the normal range. * regular menstruation. * agree and sign an informed consent form. 2. the selection criteria for dor patients are follows. * women aged 18-45. * for two consecutive menstrual cycles, 25 ≥ basal fsh ≥ 10iu/l or amh\<1.1ng/ml. * agree and sign an informed consent form. 3. selection criteria for poi patients are follows. * 18 ≤ females aged \<40 years old. * two consecutive menstrual cycles with basal fsh\>25iu/l or amh\<1.1ng/ml. * agree and sign an informed consent form. exclusion criteria: 1. patients with congenital gonadal developmental abnormalities or a family history similar to "early menopause". 2. patients with acquired organic lesions or decreased ovarian function caused by ovarian surgery. 3. patients who have undergone artificial cycle therapy with western medicine or other endocrine treatments within the past three months. 4. patients with severe primary diseases and mental disorders such as crdiovascular, cerebrovascular, liver, kidney, and hematopoietic system. 5. patients during lactation or pregnancy. 6. patients who are allergic to the drugs used in this study or have a history of allergic reactions to traditional chinese medicine. those who meet any of the above 5 criteria for dor and poi will be excluded and not included in this study. the exclusion criteria for healthy subjects are as (1), (3), (4), and (5).
pharmacokinetics and drug interaction study between rosuvastatin and cs-866 in healthy male volunteers

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and cs-866 in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy adult male volunteers aged 20 to 50 years 2. a subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints exclusion criteria: 1. a subject who had any allergic history to any drug. 2. a subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases 3. history or suspicion of current drug abuse 4. a subject who had received treatment with below listed drug within specified period prior to the first dose of study medication * within 1 month: drug known cyp inducer or inhibitor * within 2 weeks: prescribed or herbal medicine * within 1 weeks: otc medicine * within 2 days: consumption of caffeine 5. a subject who had participated in any other clinical study within the last 2 weeks 6. a subject from whom over 400ml of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
psychosocial adjustment of patients and their partners following breast cancer diagnosis

Conditions: Breast Cancer

Summary: the purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. the overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.

breast cancer is a major life event. a patient's experience of breast cancer may depend heavily on her intimate partner. however, both patients and partners may experience depressed mood or other psychosocial adjustment problems. individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. more knowledge is needed on the adjustment problems patients and partners experience and how they deal with them. the study investigates the following research questions: * which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory? * to what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa? * which factors are associated with psychosocial adjustment problems? * how do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner? a prospective, population-based cohort will be established of women diagnosed with breast cancer in denmark and their partners. the study combines questionnaire data and data from nationwide clinical and administrative registries. an invitation letter and study material will be sent to patients by mail. patients will be asked to invite their partner to participate in the study. only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up. up to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period.

Eligibility criteria:
inclusion criteria: * for patients: being a female patient diagnosed with primary breast cancer within the last four months * for patients: cohabiting with a male partner/spouse * for partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months exclusion criteria: * for patients: previous diagnosis of breast cancer or breast cancer relapse

Keywords: breast neoplasms spouses/partners couples interpersonal relations psychosocial adjustment psychological adaptation depression quality of life dyadic coping coping behavior cohort questionnaire
healthy living after knee replacement

Conditions: Arthroplasty; Overweight and Obesity

Summary: the purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

participants will be randomized to either a weight loss program or chronic disease self-management program. both programs will be phone-based and include phone calls with a health coach weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12. monthly calls with occur between months 13-18. assessments examining outcomes will be completed at baseline, 6, 12, and 18 months.

Eligibility criteria:
inclusion criteria: participants must: * have a body mass index between 25-45 kg/m2 * have had a knee replacement (including primary, staged or independent bilateral, or revision) \<6 months prior to baseline assessment * have a computer, tablet, or smartphone with active internet access to self-monitor online and/or have a device or computer compatible with fitbit * completion of baseline assessment measures (height, weight, function tests, surveys, ≥4 days valid of activity monitoring, and 1 day of dietary recall) * be english-speaking and able to read consent and study materials written in english * be willing to attend 4 in-person assessments. exclusion criteria: * have any contraindications to diet or weight loss * undergo simultaneous bilateral knee replacement or have a scheduled or anticipated knee replacement for the contralateral knee within the next 18 months * have a mobility limiting comorbidity unrelated to knee replacement (e.g. spinal stenosis, fibromyalgia, peripheral vascular disease, stroke) * are taking anti-obesity medications * are enrolled in a formal weight loss program * had or are planning to have bariatric/gastric/lap band surgery * are planning to relocate out of the columbia or greenville, sc areas in the next 18 months.
meditation and opioid consumption in total joint replacement patients undergo primary total hip and knee replacement

Conditions: Arthropathy of Knee; Osteo Arthritis Knee; Osteonecrosis; Meditation; Knee Osteoarthritis; Knee Disease; Knee Injuries; Opioid Use; Opioid Dependence; Opioid Use Disorder

Summary: the main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.

background: the center for disease control identified prescription drug abuse as one of the top 5 current health threats in the us. orthopedic surgeons rank among the top 3 prescribers of opioid analgesics. opioids are commonly used following total knee arthroplasty. peri- operative protocols have been developed to reduce opioid intake however complications related to opioid analgesics remain problematic resulting in increased morbidity and mortality. there is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids following elective total knee arthroplasty (tka). mind-body techniques including mindful medication (mm) have been demonstrated to reduce pain in acute and chronic disease states. purpose: to determine whether mindful meditation, in conjunction with standard analgesic protocols, can impact opioid consumption, pain and function following elective primary tka. methods: a prospective, randomized control trial was conducted in patients aged 18-99 with degenerative joint disease of the knee presenting for primary tka. controls received standard perioperative analgesia. in additional to standard analgesia, study patients performed isha-krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively. outcome measures: opioid consumption, time to discontinue opioids, pain by visual analog score (vas), patient-reported outcomes measurement information system 10 (promis-10) global health short form, knee injury and osteoarthritis outcome score (koos)

Eligibility criteria:
inclusion criteria: * • male and female, ages 18-89 years * narcotic naive patients ("narcotic naïve" for the purpose of this study will be no history of narcotic tolerance prior to surgery, defined by the fda as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer) * scheduled for primary total knee replacement for osteoarthritis * willing to sign informed consent form exclusion criteria: * • surgery to be performed for other disease entities (e.g., inflammatory arthritis, post septic arthritis, posttraumatic arthritis or acute fracture) * history of narcotic tolerance prior to surgery (defined by the fda as greater than or equal to 60mg oral morphine equivalents per day for 7 days or longer) * currently taking non-narcotic analgesics other than acetaminophen and non-steroidal anti-inflammatory medications (e.g. tramadol) * history of pain syndromes (e.g., fibromyalgia, complex regional pain syndrome, chronic low back pain) * dementia or other disorder of cognitive function that precludes study consent and/or participation in the mm program * in investigator's opinion, unable to complete study tasks over 12-month follow-up period
functional evaluation of kefir drink on antifatigue and exercise exercise performance-2

Conditions: Exercise Performance; Fatigue

Summary: purpose: the aim of the present study was to evaluate potential beneficial effects of kefir drink (synbio tech inc., kaohsiung city, taiwan) on fatigue and ergogenic functions following physiological challenge. methods: 16 male subjects, 8 in each group, were divided into two groups according to the principle of maximal oxygen uptake, which were (1) first-stage placebo and second-stage kefir group (hereinafter referred to as group a). (2) the first phase of kefeier, the second phase of the placebo group (hereinafter referred to as group b), after 4 weeks of supplementation, the performance and fatigue resistance tests were carried out in sequence, including: treadmill aerobic endurance exhaustion time, and fixation exercise time and intensity challenge changes in blood lactate, blood urea nitrogen concentration and creatine kinase activity, as well as differences in body composition before and after supplementation. after the first phase of the test is completed, the four weeks of emptying are performed. and after adding the crossover sample, perform four weeks of supplementation and testing again.


Eligibility criteria:
inclusion criteria: * \>20 years old * health exclusion criteria: * no smoking * drinking habits * no nutritional supplements or medications * no food allergies * normal liver and kidney function * no diabetes and other chronic diseases
prospective follow-up of the results of nail arthrodesis of the ankle

Conditions: Ankle Fractures

Summary: the goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting. patients will be asked to complete a questionnaire during follow-up consultations.


Eligibility criteria:
inclusion criteria: * patient \>18 years * having undergone septic nailing in the operating theatre * with social security coverage exclusion criteria: * patient with 6-month follow-up not possible (medical wandering, transient patient), * patient who has benefited from another means of osteosynthesis * patients whose long-term return to weight-bearing will not be possible for reasons other than ankle arthrodesis surgery. * persons able to give consent but unable to read or write french * opposes participation in the study * patients whose cognitive capacity does not allow them to answer questionnaires
a clinical research on the relation of blood drug concentration and calcium folinate rescued in high-dose mtx therapy

Conditions: Osteosarcoma

Summary: at present, the most effective drugs to osteosarcoma include adm,ddp,,hd-mtx,ifo and so on.the effective rate of single drug was about 30%, and if the chemotherapy contains hd-mtx, the survival rate can reach about 60%, so the hd-mtx is the most important component in patients of osteosarcoma. studies have shown that, mtx efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give cf is the critical point.


Eligibility criteria:
inclusion criteria: 1. proved by pathology in 60 cases of osteosarcoma patients 2. ps ≤ 2, survival period is more than 6 months 3. normal function of liver and kidney 4. no chemotherapy contraindication, patients treat with high dose methotrexate 5. get signed written informed consent form 6. have a good compliance with take blood and follow-up exclusion criteria:
a trial to investigate hyperglycemic and hypoglycemic excursions in subjects with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia

Summary: this is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.

Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 and 64 years (both inclusive) * type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit * treated with daily insulin for t1dm ≥ 12 months prior to the screening visit exclusion criteria: -