Kornimate/medical-research-clean huggingface dataset:
mindfulness-based cognitive therapy intervention to treat depression in individuals with a traumatic brain injury

Conditions: Depression; Traumatic Brain Injury

Summary: the purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury. the investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.

major depression is a significant chronic problem for people with traumatic brain injury (tbi), and its treatment is difficult. a promising approach to treat depression is mindfulness-based cognitive therapy (mbct), a relatively new therapeutic approach rooted in mindfulness-based stress-reduction (mbsr) and cognitive behavioural therapy (cbt). this multi-site, randomized, controlled trial of a mbct intervention will examine the value of this intervention in improving quality of life and decreasing depression in people with tbi. mbct may represent a time-limited, cost-effective group intervention through which clinicians would have an opportunity to address some of the most debilitating aspects of tbi.

Eligibility criteria:
inclusion criteria: * traumatic brain injury suffered more than one year ago but less than five * evidence of depression post-traumatic brain injury (beck depression inventory-ii score of 16 or greater) * ability to speak and read english * age 18 or more exclusion criteria: * inability to benefit from the intervention based a consensus process amongst study clinical psychologist and physicians, and from scores on memory and auditory attention (california verbal learning test, digit span subsection of wechsler adult intelligence scale); verbal fluency and executive functioning (controlled oral word association test); verbal abstract reasoning (similarities subsection of wechsler adult intelligence scale); and executive functioning (trail making test). * evidence of unusual psychological processes such as psychosis, suicidal ideation, substance abuse, or major concurrent mental illness (beck depression inventory-ii and symptom checklist-90-r will supplement the decision-making process of study clinicians).

Keywords: mindfulness-based cognitive therapy mbct depression traumatic brain injury tbi
the dine study-diet intervention to negate diabetes study (improving weight loss outcomes for african americans)

Conditions: Diabetes; Hypertension; Insulin Resistance

Summary: the purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight


Eligibility criteria:
inclusion criteria: * african american adults (age ≥ 19) * obese (bmi \> or equal to 30 kg/m2) * otherwise generally healthy exclusion criteria: * diagnoses of diabetes * malignancy or other states where weight loss is contraindicated (pregnancy * individuals with high blood pressure on medications.
ibuprofen versus codeine. is one better for post-operative pain relief following reduction of paediatric forearm fractures?

Conditions: Fracture; Pain

Summary: for simple fractures treated in the emergency department with cast immobilisation only, ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less side effects. these and other studies have commented that their results may not be applicable to children who have fractures that require reduction. there is currently no literature on the management of postoperative pain following reduction of paediatric fractures. the investigators aim therefore is to investigate whether either of the two most commonly prescribed analgesics is superior to the other for postoperative pain management following closed reductions of paediatric forearm fractures. also, if one agent has more side effects than the other.

this will be a prospective randomised controlled trial with the null hypothesis that there is no difference between ibuprofen and codeine in terms of pain relief or side effects. following ethics approval (submitted and approved) by the university of manitoba ethics board a study group of fifty patients (25 in each arm) will be recruited to participate in the study.all patients will complete informed consent following both a verbal and written explanation of the study. following the closed reduction they will all receive regular acetaminophen; (dose 15mg/kg) and either ibuprofen (10mg/kg) or codeine (1mg/kg) depending upon the group they were randomised to. this will have to be single blinding as the codeine formulation used by the hospital is a clear red liquid (5mg/ml) and the ibuprofen a cloudy colourless liquid (20mg/ml). they will also be given a "rescue" medication to be taken if the caregivers feel that the pain relief is not sufficient 1 hour after the study medication. this rescue medication will be the alternative medication in the study.

Eligibility criteria:
inclusion criteria: * all paediatric patients presenting to the section of paediatric orthopaedics requiring a closed reduction of a forearm fraction under either sedation or general anaesthetic. * patients who are able to return to follow up. exclusion criteria: * any children with a history of gastrointestinal bleeding or ulceration, a bleeding disorder, a history of a low platelet count, a history of kidney disease, an uncontrolled chronic disease, or regular use of or allergy to acetaminophen, ibuprofen, or codeine. * children are also ineligible if they or their parents are unable to understand the consent process. * any child requiring anything other than a cast to supplement the stability of the fracture or an open reduction and internal fixation of the fracture. open fractures.

Keywords: fracture pain fracture reduction analgesia acetaminophen ibuprofen codeine pediatric fracture pain analgesia in pediatric population
study to evaluate the effectiveness of orthopedic spinal supports in the treatment of low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether orthopedic spinal supports are effective in the treatment of low back pain.

back pain is a common and expensive medical condition. although rarely life-threatening, back disorders are a major cause of pain, disability, and social cost affecting the quality of life in most patients. although primary care providers routinely treat back pain, little is known about how often primary care providers manage occupation-related symptoms and how outcomes compare with other treatment modalities. treatment outcomes utilizing a non-operative treatment paradigm have not been adequately studied. this paradigm consists of treating patients sequentially with analgesics, physical therapy, use of back supports, caudal epidural steroid injections, or surgical referral. the use of spinal supports as a complimentary treatment along with physical therapy and posture education is promising.

Eligibility criteria:
inclusion criteria: * patients must present with clinical symptoms of low back pain and evaluated by the study physician * visual analog score (vas) for pain \>6 in response to the following question: circle one number (from 0 = no pain to 10 = worst pain) "how would you rate the worst pain you experienced in last week." * patients must have x-ray and or an mri film for diagnostic evaluation based on physician judgment. * age \>18; both male and female * pain duration \>3 months exclusion criteria: * prior use of opioids, physical therapy, epidural injections for back pain or ongoing chiropractor care and or acupuncture treatment * moderate to severe arthritis of the spine/ knee or hip that might severely compromise ambulation and or posture * patients with diagnosed lumbar canal stenosis * serious concomitant medical illness (i.e., heart disease) * obese patients (twice the width of the moller orthopedic back support) * patients with moderate to severe scoliosis * past or present existence of a movement disorder, e.g., parkinsonism, or any neurological disease that might affect ambulation and or postural changes history of osteoporosis * severe psychiatric disorder * prior spine surgery * multiple vertebral compression fractures with kyphosis * past or present workmen's compensation claim, ssi disability, or ongoing litigation

Keywords: backache low backpain sciatica
a retrospective study on the outcome of different fixation methods after olecranon osteotomy

Conditions: Distal Humerus Fractures; Osteotomy; Fixation Device; Complications

Summary: humeral intercondylar fractures are very challenging in clinical treatment. there are many problems not clear. one of the important problems remained to be solved is which fixation method can achieve the best effects after olecranon osteotomy. therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.

humeral intercondylar fractures are very challenging in clinical treatment. because the humeral intercondylar fracture is comminuted and often occurs in elderly patients with osteoporosis, it is difficult to achieve rigid fixation during the operation and failure of fixation occurs from time to time after the operation. nonunion and reoperation have brought great sufferings to the patients.in recent years, both surgical methods and technique of internal fixation have been greatly improved, but there are still many problems not clear. olecranon osteotomy has been proven to be an effective approach for comminuted intercondylar fractures and there are different fixation methods to fix the proximal ulna after intercondylar fixation. however, it is not clear which method can achieve the best effects. therefore, the investigators are going to perform a retrospective analysis of patients with distal humerus fractures admitted to their hospital in 2012-2017 to compare the functional outcomes of elbow joints with tension-band fixation and plate fixation after olecranon osteotomy.

Eligibility criteria:
inclusion criteria: 1. patients over 18 years old; 2. distal humerus fractures. exclusion criteria: 1. pathological fractures; 2. combined with fractures of ipsilateral upper limb; 3. fracture over 2 weeks; 4. patients who refused surgical treatment; 5. patients who were unable to obtain the 1 year follow-up data after the operation.

Keywords: distal humerus fractures olecranon osteotomy plate fixation tension-band fixation
a comparative study to observe the effect of concomitant use of corticosteroid treatment in rheumatoid arthritis (ra) participants who are treated with a tumor necrosis factor (tnf) inhibitor or tocilizumab (tcz) as their second biological treatment.

Conditions: Rheumatoid Arthritis

Summary: this six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between ra participants receiving tcz or a tnf-inhibitor, in participants who have discontinued the use of a tnf-inhibitor as their first biological treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * with a diagnosis of moderate to severe ra according to the revised (1987) american college of rheumatology (acr) criteria or 2010 acr/ european league against rheumatism (eular) ra classification criteria. * have had an insufficient response or intolerance to their first tnf-inhibitor (including biosimilars for tnf-inhibitors). * the treating physician has made the decision to commence tcz or tnf-inhibitor treatment. participants need to have a disease activity score (das) 28 assessment at initiation of their second biological treatment. * have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent. exclusion criteria: * have had more than one tnf-inhibitor prior to the enrolment visit. * have had biological treatment other than tnf-inhibitors. * participants that are continuously treated with per oral corticosteroids for any other indication than ra (at baseline).
timing of resective surgery after neoadjuvant chemoradiotherapy in esophageal cancer

Conditions: Cancer of the Esophagus

Summary: this study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (crt) in cancer of the esophagus or gastric cardia. patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of crt. the study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma or scc of the esophagus or gej siewert type i and ii. * tumors should be resectable and without distant metastasis, as assessed after completed crt. * patients with performance status 0-1 according to the eastern cooperative oncology group (ecog) scale at the pre crt evaluation and judges to be fit for surgery at the pre and post crt evaluations. * pre crt tumor stage: t1n1-3m0, t2n0-3m0, t3n0-3,m0, t4an0-3,m0 * written informed consent * completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant crt schedule according to protocol within a period of \<36 days. exclusion criteria: * concomitant malignant diagnosis (excluding non-melanoma skin cancer) \<5 years since current cancer diagnosis. * ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy. * patients being unable to comply with the protocol for reasons of language or cognitive function. * tumor stage t1n0, t4bnx or txnxm1. * carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy. * clear radiological signs of tumor progression during crt on ct-scan after completion of crt. pet is not used in this decision as fdg-activity often increase due to radiotherapy induced inflammation.

Keywords: adenocarcinoma squamous cell carcinoma gastroesophageal junction
open label treatment with tdcs for parkinson's and related disorders for improvement of speech, gait and mood

Conditions: Parkinson's Disease

Summary: this research will help us to understand whether transcranial direct current stimulation (tdcs) can safely improve recovery of speech and language abilities, gait , and mood in people with parkinson's disease and related disorders. some of the disorders that will be studied to understand if tdcs can be useful include parkinson's disease, multi-system atrophy (msa) and progressive supranuclear palsy (psp).


Eligibility criteria:
inclusion criteria: * parkinson's disease or a related disorder (e.g. multiple systems atrophy) as diagnosed by a neurologist specializing in movement disorders * age \>= 18 years exclusion criteria: * skull defect at or near site of tdcs delivery. * history of a significant stroke or traumatic brain injury. * history of other brain conditions that could impact interpretation of results (such as ms, brain tumor, encephalitis). * presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators) * presence of ferrous metal in the head (except titanium; for instance shrapnel) * history of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants) * pregnancy
tolerability and pharmacokinetics(pk)/pharmacodynamics(pd) study of gw003 in healthy subjects

Conditions: Chemotherapy-induced Neutropenia

Summary: this study is designed to access the tolerability and pharmacokinetic/pharmacodynamic (pk/pd) of single subcutaneous (sc) injection of gw003 in healthy subjects.


Eligibility criteria:
inclusion criteria: * 18 years to 45 years,healthy male and female subjects.in the same dose group,the age difference between in 10 years * at least 50kg weight,bmi between 19 and 25kg/m2 * no tobacco, alcohol and other bad habits * no history of drug allergy and biological agents allergy and other allergies * not used biological agents and other drugs within three months before participated in this test * not participated in other test or donated blood within three months before participated in this test * the medical history、physical examination、laboratory examination is normal or slightly abnormal * subjects can obey the clinical trial protocol * subjects, who are willing to follow the study protocol and provide written informed consent voluntarily. exclusion criteria: * history of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history) * history of drug allergy and biological agents allergy and other allergies * subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now * subjects not to take effective contraceptive measures or have a family planning within one year， pregnancy or nursing women * subjects accepted major surgery 4 weeks before drug administration * subjects vaccinated live vaccine 3 months before drug administration * subjects with the history of drug abuse 5 years before drug administration * as the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months * clinical and laboratory examination results is abnormal and have clinical significance * subjects with poor compliance or have any unfavorable factors to participate in this test * subjects can not complete the research * the researchers and their family members.
clinical utility of sudoscan in the pediatric population

Conditions: Childhood Obesity; Prediabetes; Diabetes

Summary: the main purpose of this study is to evaluate whether sudoscan is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population. primary objective: to measure sweat gland function in a pediatric population secondary objective: to determine thresholds on the sudoscan scale for abnormal sweat gland function in the pediatric population


Eligibility criteria:
inclusion criteria: * males and females ages 8 to 17 years * able to give assent as well as parental consent exclusion criteria: * history of type 1 or type 2 diabetes * chronic autoimmune condition * taking chronic immunosuppressive or anti-inflammatory medications * unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute sudoscan test * presence of hepatitis b or c * presence of hiv * presence of known neurological disorder * pregnancy and/or breastfeeding * any open wound on the soles of the feet or palms of the hands * participation in an ongoing clinical investigational drug trial * other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study
genomic profiles analysis in children, adolescents and young adult with sarcomas

Conditions: Diagnosed or Relapsed/Refractory Sarcomas

Summary: bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. for some of these tumors relapse and mortality rates are still significantly high. therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. next generation sequencing (ngs) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. the establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.


Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed osteosarcoma, ewing sarcoma or synovial sarcoma at first diagnosis. 2. patients with confirmed relapsed/refractory osteosarcoma, ewing sarcoma or synovial sarcoma 3. written informed consent signed by the patient, or parents or legal representative to perform molecular analysis of the tumor sample. 4. patients aged ≤24 years 5. pathological review of tumor samples. 6. availability of fresh tumor sample from newly diagnosed or relapsed/refractory cancer and 10 ml of edta peripheral blood sample. centralization of paraffin-embedded tumor sample might be optional. exclusion criteria: * 1. known history of active hiv, hcv, or hbv infection 2. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient undergoing surgery biopsy or the quality of the data.
nexavar-tarceva combination therapy for first line treatment of patients diagnosed with hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: this is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic child-pugh a hcc. patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.

european quality of life scale (5 dimensions) (eq-5d)

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * patients who have a life expectancy of at least 12 weeks * patients with histological or cytologically documented hcc * patients must have at least one tumor lesion that meets both of the following criteria: * the lesion can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (recist) * the lesion has not been previously treated with local therapy * patients who have an ecog ps (eastern cooperative oncology group performance status) of 0 or 1 * cirrhotic status of child-pugh class a. * patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time. exclusion criteria: * history of cardiac disease: congestive heart failure \> new york heart association (nyha) class 2; active coronary artery disease (cad); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), or uncontrolled hypertension. myocardial infarction more than 6 months prior to study entry is permitted. * abnormalities of the cornea based on history (e.g. dry eye syndrome, sogren's syndrome) including congenital abnormality (e.g. fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g. fluorescein, bengal-rose), and/or an abnormal corneal sensitivity test (schirmer test or similar tear production test). * history of interstitial lung disease (ild). * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * previous treatment with yttrium-90 spheres * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * uncontrolled ascites (defined as not easily controlled with diuretic treatment)

Keywords: sorafenib (nexavar) erlotinib (tarceva) first line hcc