Kornimate/medical-research-clean huggingface dataset:
trail evaluating particle therapy with or without apatinib for h&n adenoid cystic carcinoma

Conditions: Adenoid Cystic Carcinoma

Summary: it is a randomized phase ii study to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. participants will be randomized to arm 1: receiving apatinib for 6 weekly followed by particle radiotherapy; arm 2: particle radiotherapy alone.

the purpose of this study is to determine the efficacy and safety of particle therapy with or without apatinib as induction therapy for the treatment of head and neck adenoid cystic carcinoma. it is a randomized phase ii clinical trial with single phase and 2 experimental arms. participants will be randomized to arm 1, receiving apatinib (0.5g, daily) for 6 weekly followed by particle radiotherapy (proton: 56 gye/28 fx, plus carbon: 15 gye/5 fx for boost); arm 2: particle radiotherapy alone (proton: 56 gye/28 fx, plus carbon: 15 gye/5 fx for boost). the short term response will be evaluated using recist criteria. and the acute and late toxicities will be evaluated according to nci ctcae v4.03.

Eligibility criteria:
inclusion criteria: * pathologically confirmed acc * inoperable disease or postoperative residual disease detected by imaging studies * age ≥ 18 and ≤ 65 years of age * ecog \< 2, no significant active concurrent medical illnesses * adequate laboratory values within 30 dyas of enrollment to study defined as follows: n \> 2000/mm\^3; plt \> 100,000/mm\^3; total bilirubin \ 60ml/min * willing to accept adequate contraception for women with childbearing potential * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * presence of distant metastasis * pregnant or lactating women * a diagnosis of malignancy other than cis of the cervix, bcc and scc of the skin within the past 5 years * refusal of the patient to participate into the study

Keywords: apatinib particle therapy
influence of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in mechanical neck pain randomized clinical trials

Conditions: Neck Pain

Summary: the purpose of this study will investigate the effect of adding high power pain threshold ultrasound to traditional therapy on axioappendicular muscles amplitude and fatigue in neck pain

myofascial pain syndrome is a common musculoskeletal pain disorder affecting almost 95% of people with chronic pain disorders and is a common finding in especially pain management centres.it is characterized by trigger points, defined as hyperirritable spots within taut bands of skeletal muscle fibers. the syndrome is associated with tenderness in the muscle, referred pain, spasm and restriction of motion. patients with mps begin with one active mtrp (called the primary mtrp) in the affected muscles due to chronic repetitive minor muscle strain, poor posture, systemic diseases, or neuro-musculoskeletal lesions. when not treated correctly, expansion of the pain region and additional active mtrps (called secondary or satellite mtrps) will develop one of the most appropriate treatments for trigger points ultrasound therapy. the high-power pain threshold ultrasound (hpptus) technique is one of the ultrasound modifications used to treat trigger points in 2004, majlesi et al. performed the first clinical study to compare this technique with the traditional ultrasound technique in patients with myofascial trigger points. the results showed that hpptus was much more effective than the traditional technique, and pain reduction and improved range of motion (rom) were significant in a smaller number of sessions.sixty patients with mechanical neck pain will be assigned randomly to two equal group. one group will receive high power pain threshold ultrasound and traditional therapy and the other receive traditional therapy alone for four weeks. .

Eligibility criteria:
inclusion criteria: * patients with mechanical neck pain from both genders. * age between 19 and 38 years * patients will be required to have active trps in the upper trapezius and levator muscle and neck pain exclusion criteria: * patients will be excluded if they have history of whiplash injury, * history of cervical spine surgery, * cervical radiculopathy or myelopathy, * having undergone physical therapy within the past 3 months before the study * non- rheumatologic diseases as multiple sclerosis, * thyroid dysfunction and chronic infection and rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases.

Keywords: high power pain threshold ultrasound mechanical neck pain
change -it is about life

Conditions: Schizophrenia; Metabolic Syndrome

Summary: schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. recently, a large register-based study, involving complete national data from denmark, sweden and finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.results from the danish national indicator project for schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values. in the randomized clinical trial change, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. we will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the change team who should facilitate life style changes and contact with general practice. the objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * affiliated to outpatients services at mental health centre, copenhagen or århus university hospital * diagnose icd-10:f2 spectrum * waist circumference \> 88 cm for women or \>102 cm for men exclusion criteria: * not willing to participate

Keywords: lifestyle smoking dietary exercise
aquatic exercises for patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the goal of this study is to compare the effect of aquatic exercises (aeg) to the aquatic exercises plus aerobic training (deep-water running) (aedwrg) on functional status and pain in patients with specific chronic low back pain.

in general, the population will have at least one episode of low back pain during their lifetime, with recurrence in most cases. several treatments have been proposed for these patients and the evidence is still not clear about the effectiveness of aquatic exercises when compared to other modalities of exercises in the water. this study will be a randomized controlled trial following the consort-statement principles. the subjects, aged between 20 and 50 years, after signing the informed consent will be randomly allocated to one group treatment: aquatic exercises (aeg) or aquatic exercises associated to deep-water running (aedwrg). the duration of the protocol will be set at 12 weeks, 3x-week.

Eligibility criteria:
inclusion criteria: * exclusive diagnosis of chronic low back pain (more than 12 weeks) exclusion criteria: * central nervous system disease * pregnant * fear of water

Keywords: hydrotherapy aquatic
ib-t101 injection for treatment of patients with advanced clear cell renal cell carcinoma

Conditions: Advanced Clear Renal Cell Carcinoma; Adult

Summary: this is an open label, single center, dose escalation, and dose extension iit study aimed at evaluating the safety, efficacy, and pharmacokinetics of ib-t101 in adult patients with advanced clear renal cell carcinoma


Eligibility criteria:
inclusion criteria: 1. voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol; 2. age ≥18 years old; 3. eastern cooperative oncology group (ecog) performance status score of 0 or 1; 4. expected survival time of ≥ 3 months; exclusion criteria: 1. cns dysfunction with clinical significance. for example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the cns. 2. any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). known human immunodeficiency virus (hiv) positive subjects 3. have experienced myocardial infarction or unstable angina within the 6 months prior to screening 4. pleural effusion requiring drainage for symptom management within 28 days prior to screening
ultrasonographic assessment of optic nerve sheath diameter in children receiving caudal block

Conditions: Orchiopexy; Inguinal Hernioplasty; Hydrocelectomy; Diverticulectomy; Fistula Repair; Penoplasty

Summary: the recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. it was supposed to be associated with increased intracranial pressure. ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. the aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. in contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. the primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.


Eligibility criteria:
inclusion criteria: * pediatric patients * weighing less than 16 kg * who receive caudal block before urologic surgery exclusion criteria: * subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure * ophthalmic disease * expected operation time is less than 30 minutes * both parents are unable to communicate or speak korean.
registry of etanercept (enbrel®) in children with juvenile rheumatoid arthritis

Conditions: Juvenile Rheumatoid Arthritis

Summary: this study will evaluate long-term safety of etanercept with or without other dmards in children with polyarticular course or systemic juvenile rheumatoid arthritis (jra) compared to a cohort of subjects with polyarticular or systemic jra receiving methotrexate with or without other dmards.


Eligibility criteria:
* jra by american college of rheumatology (acr) criteria - active joints - initiate etanercept alone, etanercept plus methotrexate or other dmards, methotrexate alone, or methotrexate with other dmards within 6 months of entry into registry * polyarticular or systemic ra in 3 or more joints at start of treatment

Keywords: jra registry
online exposure therapy for obsessive-compulsive disorder (ocd) study

Conditions: Obsessive-Compulsive Disorder

Summary: the overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (erp) therapy for ocd. mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. the study team will conduct this research within the context of an effective online treatment for ocd called ocd-net. ocd-net is bibliotherapy with coaching and its content is reflective of standard care for ocd.


Eligibility criteria:
inclusion criteria: * english-speaking * located within the united states * 18-90 years old * able to provide consent * current diagnosis of ocd as assessed by clinical interview exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * participants currently located outside of the united states * prisoners * participants with hoarding as the primary ocd symptom * severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment) * concurrent enrollment in another psychotherapy treatment * participants taking psychotropic medication may be excluded if: * they have started a brand new psychotropic medication within the last 12 weeks * they have changed the dose of their psychotropic medication within the last 4 weeks * they anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study * participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).
assessment of coronary artery disease in stroke patients

Conditions: Coronary Artery Disease

Summary: this study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary ct angiography.

stroke and coronary artery disease (cad) share common risk factors and pathological mechanisms. cad is an important cause of death in patients with stroke. currently, coronary ct angiography (ccta) is very useful non-invasive tool for detection of cad and plaque analysis. therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of cad in stroke patients through follow-up (more than 5 years) using ccta.

Eligibility criteria:
inclusion criteria: * acute stroke patients who diagnosed by clinical and brain mr imaging * who performed coronary ct angiography within 3 months after acute stroke exclusion criteria: * intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage * brain tumor * previous myocardial infarction * previously performed percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or other cardiac surgery * insufficient medical record * poor image quality of ccta scan

Keywords: coronary artery disease stroke coronary ct angiography
prevention of colorectal sporadic adenomatous polyps (presap)

Conditions: Colorectal Adenoma

Summary: this study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg qd versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at month 13 (year 1) and month 37 (year 3) of study drug administration.


Eligibility criteria:
inclusion criteria: * the subject has had a documented colonoscopy to the cecum performed by a study-related physician with adequate preparation resulting in diagnosis and clearance of an adenomatous polyp(s) within 4 months prior to randomization. * the subject is willing to abstain from chronic use of all nsaids or cox-2 inhibitors excluding aspirin at cardioprotective doses for the duration of the study. exclusion criteria: * the subject has a history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer. * the subject has a history of inflammatory bowel disease.
effectiveness and health benefits of a nutritional, chronobiological and physical exercise intervention in fibromyalgia and chronic fatigue syndrome (synchronize +)

Conditions: Fibromyalgia; Chronic Fatigue Syndrome

Summary: chronic pain, fatigue and insomnia are classical symptoms of fibromyalgia and chronic fatigue syndrome, affecting seriously life quality. non-pharmacological multicomponent approach is gaining relevance in fibromyalgia treatment. however, nutrition and chronobiology are often not approached in-depth despite their potential. furthermore, programs addressed to chronic fatigue syndrome are still scare. this study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in fibromyalgia and chronic fatigue syndrome.

the investigators will perform a mixed study through a randomized clinical trial in catalonian primary care with patients diagnosed of fibromyalgia (m79.7) or both fibromyalgia and chronic fatigue syndrome (g93.3). the control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). the intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. in both groups, quality of life (euroqol-5d), as well as mfi, vas pain, psqi, ermedas-17, brian, regicor-short, fiqr and hads questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. food intake, body composition, resistance and strength will also be evaluated. the effect size will be calculated using cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. in addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.

Eligibility criteria:
inclusion criteria: * people aged 18-65, recent diagnosis of fibromyalgia (m79.1) (\<10 years), or diagnosis of fibromyalgia and chronic fatigue syndrome (m79 .7 and g93.3), with availability, motivation and interest in the intervention. exclusion criteria: * not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention

Keywords: multicomponent intervention nutrition chronobiology physical exercise quality of life primary health care
efficacy study of dextromethorphan to treat rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (dmards). disease activity were assessed.

biologic-naïve rheumatoid arthritis (ra) patients who fulfilled the 2010 criteria of the american college of rheumatology (acr) for ra were enrolled. all patient were randomized to a 6-month treatment with either oral dxm \[dextromethorphan hydrobromide; detosiv slow release® (60mg per tablet, lotus pharmaceutical company, taipei, taiwan) with t1/2 = 7.75h, tmax = 4.83h, cmax = 14.6 ng ml-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast\] or placebo pills with the same appearance as dxm tablets. the randomization was performed by the pharmacy of the taichung veterans general hospital. non-study medications were not changed during the course of study. twenty-four patients received add-one dxm therapy and the other 24 patients received traditional dmards alone in stable dose. disease activity was assessed by the 28-joint disease activity score (das28) before starting add-on dxm therapy (as a baseline) and at the end of 6 months of therapy with or without add-on dxm. patients were categorized as good, moderate or poor responders based on the amount of change in the das28 and the level of das28 reached. good responders were defined as patients who had a decrease in das28 from baseline (∆das28)\>1.2 and a das28≦3.2 at evaluation time; moderate responders had either ∆das28\>1.2 and a das28\>3.2 or ∆das28 of 0.6-1.2 and a das28≦5.1 at evaluation time; and poor responders were those who had either ∆das28\ 5.1 at evaluation time.

Eligibility criteria:
inclusion criteria: * patients fulfilling the 2010 criteria of the american college of rheumatology (acr) for ra exclusion criteria: * receive biological therapy for ra, including etanercept, adalimumab, golimumab, tocilizumab, rituximab, abatacept.

Keywords: rheumatoid arthritis
safety and immunogenicity of a vaccine dendritic cell-based pulsed with autologous heat-inactivated in hiv-1 infected patients

Conditions: HIV Infection

Summary: single-center, national clinical trial, phase i, randomized (1: 1: 1: 1), prospective, placebo-controlled, partially masked, parallel group. patients will be assigned to one of the following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with pegylated interferon.


Eligibility criteria:
inclusion criteria: 1. patient \> 18 years of age; 2. voluntarily sign informed consent; 3. men or women with a negative pregnancy test before inclusion in the study; 4. hiv infection tested (with positive antibodies to hiv-1 and a detectable viral load); 5. patient must be on stable treatment with cart at least 1 year 6. the average of all measurements of cd4 during the year before starting cart should be equal or greater than 350 cells / mm3 7. the number of cd4 + at enrollment must be equal or greater than 450 cells / mm3; 8. plasma hiv viral load undetectable at least 6 months before the inclusion in the study, at least two determinations (occasional blips above the undetectable level are allowed). exclusion criteria: 1. treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting cart; 2. history of c cdc events; 3. interruption of cart during the inclusion in the study; 4. pregnancy woman or becoming pregnant in the next months; 5. active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit; 6. therapy with immunomodulatory agents, including cytokines (eg il-2) and gamma globulins or chemotherapy within 90 days prior to the screening visit; 7. use of anticoagulant medication; 8. use of any investigational drug within 90 days prior to study entry; 9. virological failure prior to antiretroviral treatment and / or mutations that confer resistance to antiretroviral drugs; 10. uncontrolled psychiatric disorder; 11. platelet count \<80,000 / mm3; 12. values ??of hemoglobin \<12g / dl; 13. patients with active uncontrolled autoimmune diseases; 14. using contraindicated drugs in accordance with the summary of product specifications of pegylated interferon; 15. childbearing, or potential childbearing not using highly effective contraception; 16. any other problem that according to the investigator could interfere with the evaluation of the objectives. 17. any contraindication for the use of interferon peg in accordance with the summary of product characteristics.