Kornimate/medical-research-clean huggingface dataset:
fingolimod -response according to coping - evaluation

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this is a prospective, open-label, multi-center phase iv study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in france.


Eligibility criteria:
inclusion criteria: * 18-65 year-old male \& female with rrms (2005 revised mcdonald criteria) corresponding to fingolimod indication (in europe) and edss score 0 - 5.5 inclusive exclusion criteria: * history of immune system chronic disease other than ms or known immunodeficiency syndrome; increased risk for opportunistic infections, including immunocompromised patients; severe active infections, active chronic infections; negative for varicella-zoster virus igg antibodies; live or live attenuated vaccines; * active malignancies; macular edema; cardiac disease or medicines decreasing heart rate; severe liver impairment; lymphocyte count \<800/mm3; * pregnant or nursing (lactating) women /child-bearing potential unless they are using an effective contraceptive method; * hypersensitivity; participation in any clinical research study within 6 months prior to baseline; prior participation in a trial with fingolimod other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis fingolimod coping anxiety france treatment satisfaction questionnaire for medication-9 items (tsqm 9) active
ciclophosphamide, vincristine, myocet and prednisone, with rituximab in 1st-line treatment for patients with no-hodgkin b lymphoma and cardiovascular (cv) risk

Conditions: No Hodgkin B Lymphoma

Summary: the purpose of this study is to evaluate the efficacy (and safety) of the following treatment squeme:ciclophosphamide, vincristine, lyposomal doxorrubicine (myocet) and prednisone,combined with rituximab in first line treatment for patients with aggresive no hodgkin b lymphoma and cardiovascular risk

phase ii, multicenter, open , 1-arm study.

Eligibility criteria:
inclusion criteria: 1. patients with histological diagnosis of lymphoma no hodgkin b cd20+ high degree of mailgnancy 2. patients no previously treated 3. stage iii o iv 4. informed consent 5. at least one measurable injury 6. age \>18 7. ecog 0-2 8. life expectancy \>6 months 9. cardiovascular risk defined as:mild-moderate systolic dysfunction,isquemic cardiopathy, diabetes mellitus, hypertension,left ventricular hypertrophy, cardiac arrhythmia, moderate pulmonar hypertension 10. adequate organic functionallity (creatinine\ 1.5x 109/l and platellet count \>100x1097l) 11. use of a contraceptive method during study + 3 months - exclusion criteria: 1. stage i or ii with ipi=0 2. symptomatic tumoral affection of nervous central system 3. lymphoma no hodgkin b indolent 4. lymphoma no hodgkin b mantle-cell 5. lymphoma no hodgkin t 6. lymphoprolifertaive syndrome post-transplantation or immunosuppression associated 7. cardiovacualr disease symptomatic 8. cronic infection or acute serious 9. history of neoplasia in past 5 years 10. not able to understand the study or poor protocol adherence 11. known hypersensivity to any atudy drug 12. pregnant/lactant women 13. previous participation in clinicla study in past 30 days 14. previous treatment with antraciclines or any drug used in this study
vistusertib (azd2014) monotherapy in relapsed small cell lung cancer patients harboring rictor amplification

Conditions: Small Cell Lung Cancer

Summary: \[study design\] this study is a single arm, multi-center phase ii study of vistusertib monotherapy in patients with relapsed small cell lung cancer (sclc) harboring rictor amplification. patients will receive vistusertib monotherapy (50 mg bid per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria. \[primary objective\] to investigate the efficacy of vistusertib monotherapy in patients with relapsed sclc patients harboring rictor amplification as 2nd or 3rd line therapy


Eligibility criteria:
\[inclusion criteria\] * provision of informed consent prior to any study specific procedures * men and women aged at least 18 years * small cell lung cancer harboring rictor amplification * patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. * eastern cooperative oncology group (ecog) performance status of 0 to 1 with no deterioration over the previous 2 weeks * minimum life expectancy of 12 weeks * patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below: * at least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits. * no history of non-autologous bone marrow transplant. exclusion criteria: * participation in another clinical study with an investigational product during the last 21 days. * prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. prior use of an investigational monoclonal antibody therapy within 3 months. * major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment. * exposure to strong or moderate inhibitors or inducers of cyp3a4/5, pgp (mdr1) and bcrp if taken within the stated washout periods before the first dose of study treatment (see appendix 1) * exposure to specific substrates of the drug transporters oatp1b1, oatp1b3, mate1 and mate2k within the appropriate wash-out period * any haemopoietic growth factors within 14 days prior to receiving study treatment. * pre-treatment with other pi3k, akt, dual pi3k/mtro and mtor inhibitors * spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.
registry for african americans with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to better understand the causes of rheumatoid arthritis (ra), particularly in african americans.

ra is an autoimmune disease in which the body's immune system attacks its own tissues. it occurs in all races and ethnic groups and affects about two to three times as many women as men. variations in certain genes that play a role in the immune system are associated with a tendency to develop ra. some individuals without these genetic variations may develop this disease, while others who possess the variations never develop ra. scientists believe that some environmental factors may play a part in triggering the disease process in people whose genetic makeup makes them susceptible to ra. this registry of african americans with early ra will provide clinical and x-ray data and dna to help scientists analyze genetic and nongenetic factors that might predict disease course and outcomes of ra in this population. participants in this registry will be enrolled in the study until they reach 5 years in their disease duration. for example, if a participant enters the study after 1 year of having ra, he or she will continue for 4 years. participants will have three office visits (screening, 3 years' disease duration, and 5 years' disease duration) at which they will complete questionnaires and have blood samples taken, x-rays of their hands and feet, and dexa scans. between office visits, the study coordinator will call participants every 6 months to update any changes in medications or health problems.

Eligibility criteria:
inclusion criteria * african american * rheumatoid arthritis for less than 2 years

Keywords: african american, rheumatoid arthritis
study evaluating the impact on fat distribution of nucleoside reverse transcriptase inhibitor (nrti)-sparing regimens in antiretroviral experienced patients with lipoatrophy

Conditions: HIV Infections; HIV Lipodystrophy Syndrome

Summary: the aim of this trial is to evaluate the impact on fat distribution of switching to nrti-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. maintenance of virological suppression and immunological factors are also assessed.

limitations on achieving complete hiv eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. the current standard-of-care haart regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (nrtis). many studies have demonstrated that nrtis particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. this antiretroviral family inhibits also the mitochondrial gamma-dna polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.

Eligibility criteria:
inclusion criteria: * males and non-pregnant females * confirmed laboratory diagnosis of hiv infection * patients receiving a 2 or 3 nrti-containing antiretroviral treatment for at least 3 months * viral load below 400 copies/ml * patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination exclusion criteria: * current antiretroviral therapy with 3 classes of antiretroviral therapy * previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (nnrti) or protease inhibitor (pi) * intolerance to nevirapine and efavirenz * acute opportunistic infection * diabetes * transaminase levels over 5 times above the upper normal limit * hepatitis b virus (hbv) co-infection if the patient is receiving lamivudine therapy * ongoing immunotherapy including interleukin-2 (il-2) and interferon * pregnancy or planned pregnancy

Keywords: hiv infections hiv lipodystrophy syndrome
the clinical effect of i-factor® versus allograft in non-instrumented posterolateral fusion the ivanos-study

Conditions: Spinal Stenosis; Low Back Pain

Summary: the average life expectancy in denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (lss). lss causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudicatio(goh kj fau - khalifa et al.). lss occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavum, arthrosis of the facet joints and bulging of the disc. current treatment of lss is varied ranging from non-operative conservative treatment to operation. operative intervention shows very good results according to physical ability and pain(christensen fb et al.;hee ht and wong;mcgregor ah fau - hughes and hughes;xu et al.), but the most optimal treatment is still debated. nevertheless, a decompression and, if needed, a spinal fusion is recommended. the investigators want to se whether i-factor improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this difficult patient population. the hypothesis is, that there is no difference in clinical outcomes whether you use i-factor or allograft i non-instrumented spinal fusion surgery in patients with spinal stenosis due to degenerative listhesis.

se above

Eligibility criteria:
inclusion criteria: 1. spinal stenosis, listhesis grade 1-2 (\>3 mm), facet joint arthrosis and flavum hypertrophia verified by a mr-scan and x-ray including maximally 2 levels ranging from l1-s1. 2. a score of 6 and more on konno´s "history of examination characteristic". 3. signed informed content. exclusion criteria: 1. any disease demanding obligate thromboprophylaxis treatment, including mechanical valve, (dvt with cancer/thrombophilia, ami, apoplexia cerebri, tci, valve-operation)\< 3 months, coronar metal stent \< 6 weeks and coronar drug eluted/coated stent \< 12 months. 2. atrial fibrillation and one of the following: mitral stenosis, valve prothesis and apoplexia cerebri/tci. 3. atrial fibrillation and two of the following: heart insufficient, ht, dm, age \> 75 years, ef \< 35 %. 4. known cancer in the axial skeleton. 5. ongoing chemotherapy. 6. fracture i the lower back within a year prior to inclusion. 7. reduced distance of walking due to non-spinal related causes. 8. candidate for more than two-level intervention. 9. dementia assessed by the mmse 10. asa 3+4 11. age below 60 years. 12. missed 3 months of conservative treatment without success 13. the use of steroids and bisphosphonates. 14. prior radiotherapy to the lower back. 15. haematologic disease. -

Keywords: oswestry disability index (odi)
observational study of the quality of life for the chronic pain patients included in a therapeutic education program focused on relaxation techniques

Conditions: Chronic Pain

Summary: the benefit of learning psychocorporal techniques in therapeutic education on the quality of life of patients with chronic pain will be studied. the purpose of this nursing research protocol is to highlight the improvement of the quality of life of chronic pain patients through psycho-physical techniques performed during group therapeutic education workshops.

the study will be performed at centre for the study and treatment of pain. the patients with chronic pain will participate to a group programm of therapeutic education. the programm consists of 9 workshops about psycho-corporal techniques performed in group. the patients will complete questionnaries before beginning the program, at the end of the programm, 6 months after the end of the program, and 12 months after the end of program. the questionnaries will be sf36, hads, cpaq, and digital pain scale.

Eligibility criteria:
inclusion criteria: * chronic pain since more the 3months * patients for whom a group "relaxation techniques" program is planned and accepted by the patient exclusion criteria: * patient with progressive cancer pain * severe psychiatric pathology (example: psychosis, deep melancholy) * patient not compliant or refusing to participate in research * person who does not understand french, or illiterate * person physically unable to complete questionnaires (visually impaired or blind) * person protected by sections l1121-5 to l1121-8.1 of the french public health code

Keywords: visualization abdominal respiration synchronized breathing sophronisation relaxation therapy do in self-massage sophrology breathing exercise therapeutic education
pilot study: identification of a multi-omic predictive signature for preterm birth in obese african american women

Conditions: PREG1; Obesity

Summary: 1. determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of african american women differ from their pregnant non-obese counterparts 2. determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant african-american women. 3. assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (ptb) and onset of labor. 4. determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with ptb

this is an exploratory pilot study to determine the omic footprint in pregnant aa women and then compare difference between obese and non-obese pregnant aa women and comparisons by class of obesity. variations in the omic findings (vaginal and gut microbiome and urinary metabolites) will be assessed by dietary findings and by variations in gestational weight gain.

Eligibility criteria:
inclusion criteria: * age 20 or older english speaking access to internet- the dietary assessment for this study is the automated self-administered 24-hour recall (asa24-2014), a web-based instrument developed by researchers at the national cancer institute (nci). exclusion criteria: - 1. history of preterm birth and taking progesterone. progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. however, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment 2. history of antibiotic use in the last month (includes pre-biotics and probiotics). these medications will change the baseline microbiota. 3. history of chronic disease on medications

Keywords: pregnant obese omic
ai chatbot-based learning on dry eye and eye strain knowledge

Conditions: Health Behaviors; Artificial Intelligence (AI); Chatbot; Dry Eye; Eye Strain

Summary: the aim of this project is to evaluate the effectiveness of using chatbots for patient education about dry eye disease. the study will examine how the chatbot affects patients' levels of information, managing symptoms, and overall satisfaction.


Eligibility criteria:
inclusion criteria: * to be actively enrolled in the nursing program * to demonstrate baseline digital literacy. exclusion criteria: * diagnosed visual impairments, * those with prior specialized ophthalmological training, * individuals with limited digital technology proficiency
observational study on efficacy of alvesco(ciclesonide) in asthma children and adolescent in real practice

Conditions: Asthma

Summary: this is a prospective, non-comparative, open, observational study.


Eligibility criteria:
inclusion criteria: * children who is prescribed with ciclesonide for asthma exclusion criteria: * subjects with contraindications to ciclesonide use * subjects with clinically relevant concomitant disease that could compromise the patient's safety should not be included in this study.
a multi-centre study to assess the long-term performance of the depuy proxima™ hip in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis; Traumatic Femoral Fractures; Congenital Hip Dysplasia

Summary: the purpose of this study is to monitor the performance of the depuy proxima™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. a subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored


Eligibility criteria:
inclusion criteria: i) male or female subjects between 18 and 70 years of age. ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups. iv) subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the depuy proxima™ hip femoral prosthesis. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study. ii) women who are pregnant. iii) subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s). v) subjects who are currently involved in any injury litigation claims. vi) subjects for whom the surgical procedure is a revision of a previous thr or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip. vii) subjects undergoing a simultaneous bilateral hip operation. viii) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation. ix) subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily

Keywords: arthroplasty replacement hip conservative anatomic cementless
the effects of emla cream and cold application on pain, fear and vital signs before chest tube removal in children

Conditions: Chest Tube Removal; Children; Pain Management

Summary: this study is being conducted to determine the effect of emla cream and cold application on pain, fear and vital signs before chest tube removal in children aged 7-18 years.

a chest tube is a device used to drain air or fluid from the pleural cavity under sterile conditions by inserting a thin or thick tube. chest tubes adhere to the endothelium of the chest cavity after insertion and while in place. for this reason, the pulling force applied when they are removed breaks these adhesions and causes intense, localised and transient acute pain. chest tube removal pain, defined as one of the patient's worst life experiences related to the surgical procedure, is an iatrogenic pain caused by an invasive procedure. therefore, chest tube removal is a painful, anxious and frightening experience for the patient. there are few studies of pharmacological and non-pharmacological methods of pain control during chest tube removal in children. however, the management of pain associated with surgical procedures in childhood is very important for the management of pain, anxiety and fear that children will experience with future medical procedures.

Eligibility criteria:
inclusion criteria: * having two chest tubes (mediastinal/pleural) placed after open heart surgery * turkish literate * with stable vital signs * willing to participate in the research exclusion criteria: * experience with chest tube removal procedure * using analgesics other than routine procedures before the procedure * children receiving mechanical ventilation support * children who have complications in the postoperative period (heart and respiratory failure, repeated surgery, etc.) * children with a mental disability, perception problem, visual and hearing impairment * children with communication problems. • children with cold allergies

Keywords: chest tube removal children pain management