Kornimate/medical-research-clean huggingface dataset:
narcotic versus non-narcotic medication for pain management after wrist/hand fractures

Conditions: Distal Radius Fracture; Pain Management; Metacarpal Fracture

Summary: the purpose of this study is to evaluate two drug options for pain control in patients following wrist injury. participants will be randomized to one of the 2 pain relief treatments to determine what treatment provides the most effective pain relief

the purposes of this noninferiority randomized clinical trial are to determine whether: 1. the most commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 500 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic (hydrocodone 5 mg + acetaminophen 500 mg) in patients with a hand or wrist fracture. 2. the following covariates affect pain outcomes: sex/gender, age, gender-related pain expectations, paid/unpaid work roles, comorbid health status, baseline pain intensity, and employment status.

Eligibility criteria:
inclusion criteria: * all patients 18 and older undergoing non-operative management of a hand or wrist fracture will be considered eligible. * able to read and speak english exclusion criteria: * pain exceeding 7/10 on numeric rating scale or 35/50 on prwe pain scale at enrollment * nerve injury * surgeon decision that surgery is required * history of chronic opioid use * documented or suspected substance abuse * individuals currently on daily use of ibuprofen, acetaminophen or other pain-altering medication including medications like neurontin (gabapentin) and ultram (tramadol) * individuals with documented or suspected chronic pain syndrome, reported allergy or adverse reaction to hydrocodone, acetaminophen, or ibuprofen * history or symptoms of serious medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) * patients with active peptic ulcer disease (history of severe heartburn) * symptoms of infection * pregnant or lactating women * diagnosis of cognitive impairment * unable to provide informed consent * unable or unwilling to fill out the forms * prior fracture in same hand * on coumadin or plavix * other medical or psychological health conditions that preclude them from receiving either intervention * or unable to return for follow-up visits

Keywords: pain management rct
safety extension study of tanezumab when administered by subcutaneous injection to patients with osteoarthritis

Conditions: Osteoarthritis

Summary: an evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks

this study was terminated on 29 september 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * must have participated in specific phase 3 parent study exclusion criteria: * failed screening for parent study, pregnant women, lactating mothers

Keywords: musculoskeletal diseases joint diseases arthritis rheumatic diseases
neural correlates of language control in bilinguals. functional mri and stimulation mapping data in awake surgery.

Conditions: Bilingualism

Summary: for bilingual and multilingual patients, brain activation and electric stimulation mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas. the present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma. functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either english or french) or in switch condition (english and french). a stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.


Eligibility criteria:
inclusion criteria: patients: * bilingual patients with a pathology indicating an intervention in awake surgery (e.g. low-grade glioma) * at least c1-level of the cecr in both languages * at least 12 years of schooling (french bac) * right-handed (edinburgh test, 1971) * performance indicator eastern cooperative oncology group 0-2 (cf. annexe) * life expectation \> 6 month * affiliated to social insurance * having given informed consent healthy volunteers: * french-english or english-french bilinguals with at least a c1 level (cecr) in both languages * at least 12 years of schooling (french bac) * right-handed (edinburgh test, 1971) * early bilinguals: age of acquisition of both languages \< 3 years * late bilinguals: age of acquisition of the l2 \> 10 years exclusion criteria: patients: * contra-indication for mri * left-handed or ambidexter (less than +80 at the edinburgh test - 1971) * mini-mental state examination \<26 * patient who cannot respect the procedures, visits, exams described in the protocol * any other medical or psychiatric affection which renders inclusion of the patient to the study inappropriate as judged by the principal investigator healthy volunteers: * contra-indication for mri * mini-mental state examination \< 26 * age of acquisition of one of the language between 3 and 10 years

Keywords: bilinguals language control executive functions functional mri stimulation mapping brain tumors
cardiac vulnerability in potentially susceptible patients

Conditions: Heart Disease

Summary: this project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. in this project patient who have recently suffered a cardiac event are being monitored with cardiac monitors for 24 hours up to 4 times during the year following their cardiac event. similarly a second group of patients with moderate to severe heart failure will undergo similar cardiac monitoring for 24 hours, twice a week separated by 3 months. in both sets of patients home indoor pollution measures will be continuously made and used to correlate with measures of heart rate variability.

approximately 50 patients in each group will be studied. in addition to cardiac monitoring for 24 hours at each session, overnight respiratory pattern and oxygen saturation will be monitored in both groups. the exposure monitoring will include both particle mass of pm2.5 along with detailed assessment to determine that portion of the particulate exposure from outdoor vs. indoor sources.

Eligibility criteria:
for the cardiac event cases patients are selected from the brigham and women's hospital cardiac services at the time of discharge, aged 45-74, having suffered a cardiac event resulting in either an infarct or need for a cardiac procedure (angioplasty, stint, etc). for the chf patients they are selected from the bwh cardiac clinics where they have been identified and classified as stage 3 or 4 chf. for both groups residence requirements are that they reside within the greater boston area as defined by an outer ring road (route 495) and are willing to be visited at home and have the exposure assessment equipment set up in their home as well as be monitored personally.

Keywords: cardiac event heart disease particulate matter
psychological symptoms in cardiac and pulmonary diseases

Conditions: Psychological Distress; Anxiety; Depression; Cardiovascular Diseases; Pulmonary Disease; Rehabilitation; Coping Behavior

Summary: the european guidelines emphasize the importance of conducting psychological screenings to investigate the presence of stress and symptoms of anxiety and depression in patients with cardiovascular disease: depression, common among patients with cvd, is associated with increased mortality, disability, decreased adherence to healthy lifestyles and medical treatments, and together with anxiety, the risk of mortality increases by about 3 times; stress, furthermore, is associated with the development and progression of cardiovascular diseases and is correlated with low adherence and cigarette smoking. less studied, but not less important, are the incidence of anxiety, depression, and stress in pulmonary disease, the relationship between mental disorders and pulmonary diseases, as well as the effect of the psychological component on the rehabilitative outcome of such patients: for example, there is evidence that those suffering from chronic obstructive pulmonary disease (copd) present symptoms of depression and anxiety much more frequently than the general population and that these two mental disorders may exacerbate copd itself. the literature, therefore, highlights that the risk of onset of cardiovascular disease increases with the severity of mental disorder, and some psychological variables correlate with the outcomes of cardiac rehabilitation intervention, crucial for reducing rehospitalizations, myocardial infarction, and mortality, as well as for improving the patient's quality of life and ability to perform physical exercises. in light of this evidence and the recent recommendations of the esc, the present study aims to conduct screening for symptoms of anxiety, depression, and stress in all patients admitted to the cardiology and pulmonary rehabilitation units of the milan center, camaldoli in order to assess their incidence and to select, through validated tools, patients who require personalized psychological intervention based on their level of risk, correlating then the presence of such symptoms with the rehabilitative outcome, in order to assess how much the mental component interferes with the care pathway. the level of acceptance and feasibility of a computerized data collection procedure will also be evaluated, a procedure that, if well accepted, would make the screening process much simpler, safer, and more economical.


Eligibility criteria:
inclusion criteria: * aged≥18 * able to fulfil questionnaires autonomously exclusion criteria: * no italian comprehension, * severe visuoperceptive deficits, * cognitive deterioration preventing self-completion of questionnaires, * refusal to underwent to the evaluation
safety & efficacy of eculizumab to prevent amr in living donor kidney transplant recipients requiring desensitization

Conditions: Antibody Mediated Rejection

Summary: the purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (amr) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

the main objective of this study was to evaluate the safety and efficacy of eculizumab to prevent amr in sensitized recipients of living donor kidney transplants requiring desensitization therapy prior to transplantation. the primary endpoint focused on acute amr during the first 9 weeks post-transplantation. patients were to be vaccinated against n. meningitidis at least 14 days prior to study drug initiation and revaccinated 30 days later. if not vaccinated 14 days prior, prophylactic antibiotics were to be administered. pre-transplant infectious disease assessment was to be performed as part of the screening assessment. patients were to undergo desensitization therapy according to the practice of the local transplant center prior to transplantation, and this desensitization practice was to be uniformly applied for all patients at that center throughout the study. the actual length of desensitization for an individual patient was based on the clinical judgment of the transplant center team. rituximab was prohibited in all patients as part of the pre-transplantation desensitization therapy due to potential pharmacodynamic interactions. the control group was designed to test eculizumab against the best available care (referred to as standard of care, or soc) consisting of plasmapheresis (pp) and/or intravenous immunoglobulin (ivig). the best available care consisting of pp and ivig was chosen because these modalities combined represented the most prevalent therapy reported in the literature and were the best available therapies at the time of this protocol's inception as per the transplant community.

Eligibility criteria:
inclusion criteria: 1. male or female patients ≥18 years old 2. patients with stage iv or stage v chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation exclusion criteria: 1. abo incompatible with living donor 2. any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient

Keywords: antibody mediated rejection amr acute humoral rejection ahr living donor kidney transplant
intrathecal additives for spinal anaesthesia in elective caesarean sections

Conditions: Pain, Postoperative

Summary: we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classii-iii adult female patient (age :18 -40 years old ) * elective cesarean section under spinal anaesthesia * gestational age \> 37 weeks * bmi less than 30 kg/m2 exclusion criteria: * patient refusal * unable to give consent * age \ 40 * bmi more than 30 kg/m2 * known allergy to the study medication * coagulopathies or on anticoagulant medications * diabetic neuropathy * patients with psychiatric disorders
post-operative corticosteroid treatment after mitral valve surgery

Conditions: Atrial Fibrillation

Summary: the aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. prospective double-blinded randmized international multicenter study.

voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. end points are atrial fibrillation onset or fullfilling the three days time limit. the study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. patients are recruited from oulu university hospital, finland, kuopio university hospital, finland, helsinki university hospital, finland, turku university hospital, finland, tampere univerisity hospital, finland, tartu university hospital, estonia, tallinn regionaalhaigla, estonia and liverpool hospital, sydney, australia.

Eligibility criteria:
inclusion criteria: * open mitral valve surgery * patients agrees to participate in the study * adult (minimum 18 years of age) exclusion criteria: * atrial fibrillation onset before first postoperative morning * prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day) * patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability * diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment * systemic mucous infections * known allergy or oversensitivity to hydrocortisone * cushing syndrome * history of psychosis * history of ulcus or active ulcus * chronic atrial fibrillation or atrial flutter * corticosteroid or immunosuppressive treatment in use for any reason * active tuberculosis infection * severe renal impairment (serum creatinine 200 umol/l or over) * history of deep or superficial venous trombosis * herpes simplex -ceratitis

Keywords: postoperative atrial fibrillation post cardiac surgery corticosteroid
a study to evaluate the efficacy and safety of faricimab (ro6867461) in participants with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (q8w), in participants with diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: * documented diagnosis of diabetes mellitus (type 1 or type 2) * hemoglobin a1c (hba1c) of less than or equal to (≤)10% within 2 months prior to day 1 * macular thickening secondary to diabetic macular edema (dme) involving the center of the fovea * decreased visual acuity attributable primarily to dme * ability and willingness to undertake all scheduled visits and assessments * for women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment exclusion criteria: * currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to day 1 * uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmhg) and/or a diastolic value \>100 mmhg while a patient is at rest * currently pregnant or breastfeeding, or intend to become pregnant during the study * treatment with panretinal photocoagulation or macular laser within 3 months prior to day 1 to the study eye * any intraocular or periocular corticosteroid treatment within 6 months prior to day 1 to the study eye * prior administration of ivt faricimab in either eye * active intraocular or periocular infection or active intraocular inflammation in the study eye * any current or history of ocular disease other than dme that may confound assessment of the macula or affect central vision in the study eye * any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than dme in the study eye * other protocol-specified inclusion/exclusion criteria may apply
prematurity and parental involvement in child development care

Conditions: Premature Birth

Summary: the aims of the study is to evaluate the association between presence and parental participation in perinatal care and psychic development of the child at 24 months

in france, as in developed countries, the premature birth rate has been rising over the past few years. premature labor is a particularly stressful birth. it is recognized that the level of parental stress is greater at a premature birth compared to a term birth. the neuro-developmental consequences of premature birth are important. a possible association between prematurity and the onset of mental disorders such as hyperactivity, inattention, emotional problems, conduct disorders, autistic disorders and social difficulties has been shown. it has been shown that parental presence, holding and skin to skin during hospitalization would be beneficial for the child's motor development and psychological well-being by reducing the stress of the child.

Eligibility criteria:
inclusion criteria : child born very prematurely between 27 and 31 weeks gestational age + 6 days child taken in charge at the intensive care unit of reims university hospital for at least 3 weeks child aged 24 months (+/- 2 months) the holders of parental authority are more 18 years old the holders of parental authority know how to speak, read and write french the holders of parental authority agree to participate in the study exclusion criteria : - child has a serious pathology (abnormal brain mri)

Keywords: parental presence parental involvement parental stress development care psychic development
radiofrquency ablation combined with cytokine-induced killer cells for the patients with ovarian carcinoma

Conditions: Ovarian Carcinoma

Summary: the purpose of this study is to determine whether combining of radiofrequency ablation (rfa) and cytokine-induced killer cells (cik) transfusion can prolong survival of patients with ovarian carcinoma.

the primary objective is to evaluate whether rfa followed by cik transfusion can prolong survival of patients with ovarian carcinoma.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with figo stage ii ovarian carcinoma; 2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed; 3. medical records maintain comprehensive data on treatment and follow-up; 4. no history of previous malignancies. exclusion criteria: 1. neoadjuvant chemotherapy applied; 2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed; 3. medical records maintain incomplete data on treatment or follow-up; 4. history of previous malignancy.
the efficacy and safety of electronic stimulation in patients who underwent reconstruction of the anterior cruciate ligament

Conditions: Knee Injuries

Summary: this study is designed to evaluate the efficacy and safety of myospare, a non-invasive device, which is connected to the body via electrodes placed in the injured leg. the electrodes which are placed in the middle or upper thigh will stimulate the quadriceps muscle. myospare will be installed 1 day after the anterior cruciate ligament (acl) reconstruction surgery and will be removed after 6 weeks of treatment. the patients will be assigned to two groups: 1. physiotherapy plus myospare 2. only physiotherapy the hypothesis of the study is that electrical stimulation combined with voluntary exercise is more effective than voluntary exercise alone.


Eligibility criteria:
inclusion criteria: 1. males and females between 18-40 years old. 2. subjects who are planning to undergo acl surgery. 3. the surgery is performed within 3 weeks - 5 years since the injury. 4. ability to follow instructions during the study period. 5. signed informed consent. exclusion criteria: 1. bi-lateral surgery of the knee 2. recurrent acl surgery (patients who already underwent acl surgery) 3. complex injuries (a combination of posterior and anterior cruciate and lateral ligament injury) 4. patients who underwent or are planned to undergo cartilage implantation. 5. patients who underwent or are planned to undergo meniscus stitching. 6. additional fracture/s in the lower limbs as a result of the same injury. 7. signs of infection in the surgical wounds while installing the myospare device. 8. known skin hypersensitivity. 9. known heart disease 10. patients with a cardiac pacemaker. 11. history of peripheral blood vessel disease 12. administration of drugs which might disrupt bone metabolism: * total accumulating dosage of 150 gr' prednisone or any other glucocorticoid for seven days or more, within 6 months prior to the trial. * calcitonin for 7 days or more, within 6 months prior to the trial. * bisphosphonates for 30 days or more within 12 months prior to the study. * fluoride for bone strengthening for 30 days or more within 12 months prior to the study. * vitamin d or vitamin d metabolite for bone strengthening for 30 days or more within 12 months prior to the study. * current treatment with chemotherapeutic drugs. 13. past or current malignant disease within 10 years of study entry. 14. participating in another clinical study during the past four weeks. 15. patients who are planned to undergo femoral nerve block. 16. patients claiming social security/work accident benefits. 17. professional athletes whose livelihood depends on sports. 18. pregnant and or lactating women. 19. additional symptoms, which in the doctor's opinion would prevent inclusion of the patient in the study.

Keywords: anterior cruciate ligament reconstruction surgery