Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of immunoglobulin associated with rituximab versus rituximab alone in childhood-onset steroid-dependent nephrotic syndrome

Conditions: Steroid-Dependent Nephrotic Syndrome

Summary: idiopathic nephrotic syndrome (ins) is the first glomerulopathy in children and 60% of the patients develop steroid-dependant nephrotic syndrome (sdns). recently, rituximab (rtx), a humanized anti-cd20 antibody depleting b cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. however, the remission rate after 2 years is only 30 to 40%. the aim of the study is to study the ability of intravenous immunoglobulin to improve remission rate in sdns when added associated with rituximab compared to a treatment by rituximab alone.

idiopathic nephrotic syndrome (ins) is the first glomerulopathy in children and 60% of the patients develop steroid-dependant nephrotic syndrome (sdns). depleting b cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. however, the remission rate after 2 years is only 30 to 40%. the aim of the study is to study the ability of intravenous immunoglobulin to improve remission rate in sdns when added associated with rituximab compared to a treatment by rituximab alone.

Eligibility criteria:
inclusion criteria: * childhood onset nephrotic syndrome (first flair \<18 years) * ≥ 2 years old at inclusion * steroid-dependent: * patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation. * patient with at least 2 relapses including one under steroidsparing agent (mmf, calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months of treatment withdrawal. * or with frequent relapses: · 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period. * with a relapse within 3 months prior to inclusion * in remission: protein-over-creatinine ratio ≤ 0.2g/g (≤ 0.02g/mmol) exclusion criteria: * patients with steroid-resistant nephrotic syndrome; * patients with genetic nephrotic syndrome; * patients previously treated with rituximab; * patients with no affiliation to a social security scheme (beneficiary or legal); * prior hepatitis b, hepatitis c or hiv infection; * pregnancy or breastfeeding. * patients with hyperprolinaemia, * known hypersensitivity to one of the study medication, * scheduled and not postponable injection of live attenuated vaccine * protected adults * patients with neutrophils \< 1.5 g/l and/or platelets \< 75 g/l
effects of diet selection based on genetic screening on success to a weight loss program

Conditions: Diet Modification

Summary: the purpose of this study is to determine the effects of diet type selection based on response to a carbohydrate intolerance questionnaire (ciq) and genetic screening on success to a weight loss and exercise program.

the purpose of this study is to determine if stratification of individuals based on responses to a carbohydrate intolerance questionnaire (ciq), genetic screening, and/or dna methylation affects weight loss success and/or health outcomes of women following the curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).

Eligibility criteria:
inclusion criteria: * the participant is an apparently healthy female * the participant is between the ages of 18 and 60 exclusion criteria: * the participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months * the participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease * the participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications * the participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, hmb), anabolic/catabolic hormone levels (androstenedione, dhea, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months * the participant is willing to take participate in a regular moderate exercise program
long term follow-up of persistent pain, sensory disturbances and lymphedema after breast cancer treatment

Conditions: Breast Cancer; Pain; Post Operative Pain; Lymphedema; Neuropathy

Summary: persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. the investigators have previously published data on 3253 women treated for breast cancer in denmark in the period 2005-2006. very few studies have examined how these late effects change in time. the aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.


Eligibility criteria:
inclusion criteria: * diagnosed with primary breast cancer between 2005-2006 * participated in a study in 2008 exclusion criteria: * recurrent or new primary cancer * metastatic cancer * reconstructive surgery

Keywords: breast cancer persistent pain neuropathic pain lymphedema
role of volatile anesthetics for hepatic protection

Conditions: Reperfusion Injury

Summary: this study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. in the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).

organ protection; preconditioning; volatile anesthetics; ischemia reperfusion

Eligibility criteria:
inclusion criteria: * older than 18 years of age * patients undergoing liver resection (benign or malignant tumors) exclusion criteria: * laparoscopic liver resection coagulopathy (platelets \< 50,000/ml, quick \< 50%) * liver cirrhosis

Keywords: surgery with pringle maneuver needed for liver resection
open-label clinical trial to investigate the safety and tolerability of allogeneic b-cell concentrates for immune reconstitution after allogeneic stem cell transplantation measured as response to a antedated single vaccination

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Myeloid Leukemia; Non Hodgkin's Lymphoma; Hodgkin's Disease; Myelodysplastic Syndrome; Multiple Myeloma; Aplastic Anemia

Summary: the reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. particularly memory b-lymphocytes reconstitute poorly with the current conditioning regimes. during the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.the adoptive transfer of b-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. aim of the study is to evaluate a new cellular therapy with b-lymphocytes regarding safety. a booster vaccination after b-lymphocyte transfer will evaluate the functionality of the transferred b-lymphocytes in the patient.


Eligibility criteria:
inclusion criteria: 1. patients after allogeneic stem cell transplantation 2. serostatus for ebv: r-/d- oder r+/d- oder r+/d+ exclusion criteria: 1. serostatus for ebv: r-/d+ 2. severe acute graft versus host disease (gvhd) (glucksberg grade iii und iv) 3. chronic gvhd in middle- or high-risk group according to nih staging 4. rituximab administration after sct 5. \>10.000 ebv dna copies/ml plasma 6. recurrence of the haematological disorder needing therapeutic intervention 7. secondary transplantation 8. sct with transplant from a haploidentical donor 9. sct with transplant from umbilical cord blood 10. cd34+-enriched transplant 11. in vitro t-cell depleted transplant 12. pregnant or breast-feeding female
kappa-pet imaging and naltrexone in alcohol drinking behaviors

Conditions: Alcohol Drinking

Summary: the primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (ntx), a medication that has been approved for the treatment of alcohol dependence. receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. drugs can bind to those receptor molecules as well. recent evidence suggests that kappa opioid receptors (kor's) may play an important role in alcohol drinking behavior. this study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. we will use pet (positron emission tomography) for this study. pet is a type of imaging device found in nuclear medicine. it is used for tracking the presence of injected radioactive materials in the body.


Eligibility criteria:
inclusion criteria: * ages 21-50 * able to read english at 6th grade level or higher and to complete study evaluations * regular alcohol drinker exclusion criteria: * individuals who are seeking alcohol treatment * medical conditions that would contraindicate the use of study medication * regular use of other substances

Keywords: alcohol drinking drinkers alcohol drinking naltrexone alcohol dependence alcohol abuse alcohol-related disorders ethanol alcoholism
daily remote ischaemic conditioning following acute myocardial infarction

Conditions: Post Myocardial Infarction

Summary: remote ischaemic conditioning (ric) is known to reduce infarct size post mi when used in the peri/immediate post infarct period. however little is known as to the effect of repeated remote conditioning post-mi (myocardial infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. in this phase ii first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post mi patients. the principal hypothesis is that ric applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: * lvef \< 45% on baseline echo * first stemi * successful revascularisation by ppci * able to attend regional centre for follow-up appointment * competent to consent exclusion criteria: * \< 18 of age * icd or crtp/d in-situ * prior history of heart failure * haemoglobin \< 11.5 g/dl * creatinine \> 200 µmol/l (egfr\<30ml/min/m2) * known malignancy/other comorbid condition which in the opinion of the investigator is likely to have significant negative influence on life expectancy * significant complications/illness following mi * unable to undergo cmri * further planned coronary interventions * enrollment in another clinical trial

Keywords: remote ischaemic conditioning remodeling heart failure myocardial infarction ischaemia/reperfusion injury successful primary percutaneous coronary intervention following a first stemi
lag of accommodation with dot spectacle lenses

Conditions: Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast

Summary: the objective of the study is to measure the difference in the lag of accommodation between dot spectacle lenses and control spectacles.


Eligibility criteria:
a person is eligible for inclusion in the study if he/she: 1. age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age. 2. is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years. 3. is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document. 4. should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00d and -1.00d. 5. is willing and able to follow instructions. a person will be excluded from the study if he/she: 1. is participating in any concurrent clinical or research study. 2. have a history of myopia control treatment in the past year. 3. has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency. 4. has any known active ocular disease and/or infection. 5. has a systemic condition that in the opinion of the investigator may affect a study outcome variable. examples include diabetes mellitus, hyperthyroidism. 6. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. examples include atropine eye drops. 7. has undergone strabismus surgery, refractive error surgery or intraocular surgery. 8. is a child of a member of the study team.
a study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo

Conditions: Vitiligo

Summary: vitiligo is a common chronic autoimmune disease that causes the body's immune system to attack its own pigment producing skin cells. this study is to evaluate how safe and effective upadacitinib is in participants with non-segmental vitiligo (nsv). adverse effects and change in disease activity will be assessed. upadacitinib is an approved drug for various immune-mediated inflammatory diseases and is currently being investigated for the treatment of nsv. there will be 2 replicate studies running at the same time (study 1 and study 2 with periods a and b) and an optional exploratory narrow-band ultraviolet b (nb-uvb) phototherapy study (study 3). in period a, participants are placed in 1 of 2 groups called treatment arms. each group receives a different treatment. there is a 1 in 3 chance that participants will receive placebo and 2 in 3 chance participants will receive upadacitinib. in period b, all participants will receive upadacitinib. approximately 270 adult and adolescent participants with nsv will be enrolled in each main study ((study 1 and study 2, 540 subjects total) at approximately 90 sites worldwide with an option for adult participants who completed period a of either study and did not achieve t-vasi 90 at week 48 while on study drug, to enter study 3. in studies 1 and 2: period a, participants will receive oral tablets of upadacitinib or placebo once a day for 48 weeks. in period b, participants will receive oral tablets of upadacitinib 15 mg once a day for 112 weeks. participants will be followed up for 30 days. study 3 participants will receive upadacitinib monotherapy or upadacitinib with nb-ubv phototherapy for at least 24 weeks followed by upadacitinib alone. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of non-segmented vitiligo (nsv). * at screening and baseline visits, participants must satisfy at least 1 of the following criteria: * \>= 0.5 f-vasi and 5 \<= t-vasi \< 50 and have failed at least 1 topical corticosteroid and/or at least 1 topical calcineurin inhibitor for vitiligo; or * \>= 0.5 f-vasi and 5 \<= t-vasi \< 50 and have a sign of actively progressing vitiligo; or * \>= 0.5 f-vasi and 10 \<= t-vasi \< 50. exclusion criteria: * segmental or localized vitiligo. * history of active skin disease other than vitiligo that could interfere with the assessment of vitiligo. * \>33% leukotrichia in areas of vitiligo on the face or \> 33% leukotrichia in areas of vitiligo on the body (including the face).

Keywords: vitiligo non-segmented vitiligo viti-up upadacitinib
comparison of estrogen-progestin therapy in continuous regimen versus combination estrogen-progestin therapy in continuous regimen plus levonorgestrel-releasing intrauterine system (lng-ius)

Conditions: Adenomyosis; Chronic Pelvic Pain

Summary: adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. it affects about 15-20% of the female population. the symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. regarding treatment levonogestrel-releasing intrauterine system, gonadotropin releasing hormone (gnrh)-analogues, danazol, uterine embolization and endometrial ablation have been tried. the aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and lng-ius or lng-ius alone


Eligibility criteria:
inclusion criteria: * women affected by adenomyosis with pelvic pain \> 4; * negative pap smear test exclusion criteria: * pregnancy or research of pregnancy * refusal or inability to sign informed consent * severe underlying comorbidities (hepatic, oncological) * pelvic inflammatory disease * other cervical or uterine pathologies * deep venous thromboembolism * hormonal therapy contraindications * smoke
oral hygiene related self-efficacy, general self-efficacy and daily plaque control

Conditions: Dental Plaque

Summary: the objectives are a) to determine the scores of general self-efficacy (gse) and oral hygiene related self-efficacy (ohse) b) to evaluate the relations between the scores of gse and ohse c) to examine the changes in ohse scores and the relationship between ohse and pi scores after motivation and oral hygiene instructions. ohse scores could be an indicator in predicting daily plaque control of patients. also, it may be needed to show greater interest about motivation and oral hygiene instructions especially for smokers and ohse-low group patients.

all study patients (n=210) between the ages of 35 to 60 with inflammatory periodontal diseases filled out questionnaires regarding gse and ohse. subgroups including ohse-low (n=26) and ohse-high (n=26) groups were selected after performing "cut off" on ohse scores of all study patients. in both subgroups, plaque index (pi) values were determined, and motivation and oral hygiene instructions were performed at baseline. pi measurements and ohse questionnaire were repeated at 1 and 3 months.

Eligibility criteria:
inclusion criteria: inclusion criteria were being able to brushing and interdental cleaning physically and mentally, between the ages of 35 and 60, graduated from high school or university, having at least 12 teeth, no periodontal treatment in the last 6 months, no periodontal surgery in the last 2 years. exclusion criteria: patients with one or more of the following criteria were excluded from the study: patients having hepatitis or hiv infectious disease, pregnant and lactating females, patients taking drugs that may cause gingival bleeding and gingival enlargement, and bleeding problems (thrombocytopenia, hemophilia a-b, iron deficiency anemia etc.).
adiposity, cardiometabolic and neurocognitive health among ethnic groups: a feasibility and pilot study

Conditions: Metabolic Disease; Obesity; Hepatic Steato-Fibrosis; Cardiovascular Diseases; Cognitive Impairment

Summary: the goal of this pilot and feasibility study is to is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at kings college hospital nhs foundation trust (kch). the main aim is to assess and compare anthropometric measurements of adiposity (weight, body mass index (bmi), waist circumference (wc), waist-to-hip ratio (whr), neck circumference (nc)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background. participants will come at kch for one visit and will have their anthropometric measurements and cardio-metabolic profile assessed. they will also perform questionnaires on lifestyle, socio-economic status and neuro-cognitive health during their visit.

the first objective of this study is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at kings college hospital nhs foundation trust. the second objective is to assess and compare anthropometric measurements of adiposity (weight, body mass index (bmi), waist circumference (wc), waist-to-hip ratio (whr), neck circumference (nc)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background. the third objective is to test the feasibility of assessing cognitive function, in relation to adiposity, by using standardised tests measuring cognitive function (mmse, moca or an adapted version) among ethnic groups of various education levels and literacy, lifestyle and from different cultures. our objective is also to test the feasibility of using lifestyle questionnaires \[food frequencies questionnaires (ffq) and international physical activity questionnaires -(ipaq-s)\] in various ethnic groups with regard to geographic variation (urban, rural).

Eligibility criteria:
inclusion criteria: * men and women aged ≥18 years old * body mass index (bmi) ≥ 30 kg/m2 exclusion criteria: * severe obesity (bmi \> 50 kg/m2) * pregnancy (positive urine hcg) or a recent pregnancy (in the past 6 months) * known active chronic hepatic diseases * known diagnosis of human immunodeficiency virus * pre-established diagnosis of advanced renal failure (estimated glomerular filtration rate (egfr) \<30 ml/min) * diagnosis of decompensated heart failure * history of bariatric surgery * uncontrolled thyroid disease * current use of the following medication: steroids (oral or injections only), weight-loss medication including over-the-counter products, glucagon-like peptide 1 (glp-1) agonists , sodium-glucose transport protein 2 (sglt2) inhibitors

Keywords: obesity multi-ethnicity cardiovascular diseases hepatic steatosis metabolic diseases