Kornimate/medical-research-clean huggingface dataset:
effect of permeaprotect on the quality of life of patients with fibromyalgia

Conditions: Fibromyalgia

Summary: fibromyalgia is a medical disorder characterized by chronic widespread pain, and a heightened and painful response to pressure. fibromyalgia symptoms are not restricted to pain, leading to the use of the alternative term fibromyalgia syndrome for the condition. other symptoms include functional gastrointestinal pain and discomfort. the origin of these symptoms is not yet known, and a few hypotheses have been stated. one of the supposed mechanisms that may lead to gastrointestinal hypersensitivity is a chronic, low-grade, intestinal inflammation due to an increased intestinal permeability. in this study, we hypothesise that the food supplement permeaprotect (that contains, amongst other nutrients, glutamine and curcumin) contributes to reducing the intestinal permeability and low-grade inflammation, thus improving gastrointestinal quality of life.

patients diagnosed with fibromyalgia will enter the study and follow a run-in phase during which they will all be supplemented with prebiotics, probiotics and grape fruit seed extract for 5 weeks : * patients that do not present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will enter the randomised phase after 2 weeks +/- 1 week, at day d0. * patients that do present a satisfactory relief of gastrointestinal symptoms (patient subjective evaluation) will exit the study at that point, and follow their usual medical care. patients that enter the randomised phase will be supplemented with either permeaprotect or a placebo, for 5 weeks +/- 1 week. patients will then follow a 2 weeks +/- 1 week of wash-out, during which no supplementation will be made. measures of the outcomes will be made : * at day 0 (beginning of supplementation). * at day 35 (+/- 7) (end of supplementation). * at day 49 (+/- 7) (end of follow-up, end of study)

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 30 kg/m² * diagnosed fibromyalgia, according to the american college of rheumatology criteria * functional bowel discomfort or pain * pre-menopausal woman with active contraception or post-menopausal woman exclusion criteria: * allergy to one (or more) component(s) of verum or placebo. * disease or disease treatment that could interfere with the efficacy evaluation. * treatment with statin (or hmg-coa reductase inhibitors) associated with adverse effect * treatment with coumadin (or any other vitamin k antagonists) * severe depression (beck depression inventory score \> 16) * recent (during the previous month) change(s) in probiotic intake (including fermented milk, kefir, ...) * history of major gastrointestinal surgery or inflammatory bowel disease * pregnant, breastfeeding or intention of pregnancy in the next three month

Keywords: fibromyalgia irritable bowel syndrome
pharmacometrics analysis of rivaroxaban in chinese children aged over 2 years

Conditions: Kawasaki Disease; Coronary Artery Aneurysm; Rivaroxaban; Anticoagulant Drugs; Pharmacokinetics and Pharmacodynamics

Summary: based on an established kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after kawasaki disease who received rivaroxaban treatment. rivaroxaban plasma concentrations, anti-factor xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis


Eligibility criteria:
inclusion criteria: 1. giant coronary artery aneurysm(s) in any coronary artery after acute stage of kawasaki disease. giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of z-score ≥10 or coronary artery internal diameter ≥8mm; 2. anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months; 3. children aged 2 years to \<18 years exclusion criteria: 1. active bleeding or bleeding risk contraindicating anticoagulant therapy 2. hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment 3. patients participating in clinical trials of other drugs at the same time

Keywords: kawasaki disease coronary artery aneurysm population pharmacokinetic and pharmacodynamic rivaroxaban anticoagulant
safety and efficacy of recombinant grass pollen allergen cocktail in the treatment of allergic rhinoconjunctivitis

Conditions: Allergy

Summary: the trial is performed to assess efficacy and safety of a recombinant grass pollen allergen cocktail in allergic rhinoconjunctivitis


Eligibility criteria:
inclusion criteria: * positive skin prick test reaction to grass pollen * positive rast result to grass pollen * positive provocation test result to grass pollen exclusion criteria: * serious chronic diseases * other relevant perennial allergies

Keywords: allergy grass pollen recombinant
the effect of central sensitization and neuropathic pain after total knee arthroplasty

Conditions: Neuropathic Pain

Summary: it has been well known that central sensitization (cs) is a risk factor for inferior outcomes following total knee arthroplasty (tka). however, there are still insufficient studies on the relationship between cs and neuropathic pain (np), and the effects of cs and np on the patient-reported outcome measures (proms) of patients who underwent tka. the purpose of this study was to investigate the relationship between cs and np and whether cs and np were associated with prom in patients undergoing tka.

a total of 312 patients who underwent primary tka for end stage knee oa were enrolled. cs was defined as a patient with a score of 40 or higher using central sensitization inventory (csi). np was defined as a patient with a score of 12 or more using pain detect questionnaire (pdq). proms were also evaluated based on the western ontario and mcmaster universities osteoarthritis index (womac) score preoperatively and at postoperative 1 year. the patients were divided into 4 groups, group 1 with cs and np positive, group 2 with only cs positive, group 3 with only np positive, and group 4 with cs and np negative, and prom was compared between the groups.

Eligibility criteria:
inclusion criteria: * primary knee degenerative osteoarthritis * patients for total knee arthroplasty over the age of 60 * patients with 2 year postoperative medical records exclusion criteria: * rheumatoid arthritis * other inflammatory arthritis * neuropsychiatric patients * hepatic insufficiency * renal insufficiency * allergy or intolerance to study medications * patients with an acetylsalicylic acid of iv (angina, congestive heart failure, dementia, cerebrovascular accident) * chronic opioid use (taking opioids for longer than 3 months) * alcohol, drug abuser * narcotics addiction
endotag-1 / gemcitabine combination therapy to treat locally advanced and/or metastatic adenocarcinoma of the pancreas

Conditions: Adenocarcinoma; Metastasis; Pancreas Neoplasms

Summary: the intention of this trial is to evaluate safety and efficacy of a combination treatment of endotag-1 with gemcitabine versus gemcitabine monotherapy.


Eligibility criteria:
inclusion criteria: * inoperable adenocarcinoma of the pancreas * histologic or cytologic confirmation * at least 18 years of age exclusion criteria: * any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment * major surgery within 4 weeks prior to enrollment * major cardiovascular disease

Keywords: adenocarcinoma of the pancreas locally advanced metastatic
randomized trial of iron supplementation to prevent anemia in very-low-birth-weight infants

Conditions: Anemia

Summary: the purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (hct) at 36 weeks' postmenstrual age (pma). all infants have a decline in hemoglobin(hgb) after birth because of increasing pao2 and hgb saturation after birth. in very low birth weight (vlbw) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth. vlbw infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Eligibility criteria:
inclusion criteria: 1. birth weight: \< 1500 grams 2. tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age 3. ≤32 weeks adjusted post-menstrual age at the time of enrollment exclusion criteria: 1. cyanotic heart disease 2. bowel resection prior to enrollment
application of transcranial direct current stimulation (tdcs) for gait function improvement of parkinson's disease patient

Conditions: Parkinson Disease

Summary: the purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tdcs) and treadmill gait training for gait function recovery in parkinson's disease patients with gait impairment.


Eligibility criteria:
inclusion criteria: * age: 50 - 75 years * modified hoehn and yahr stages 1 to 4 exclusion criteria: * serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) * difficult to understand experimental tasks because of extremely severe cognitive impairment (korean-mini-mental state examination, k-mmse≤10) * history of psychiatric disease * implanted objects that would contraindicate tdcs

Keywords: transcranial direct current stimulation gait training parkinson's disease
physical activity to maintain quality of life and physical function in women with metastatic breast cancer: a pilot study

Conditions: Metastatic Breast Cancer

Summary: metastatic breast cancer (mbc) is an incurable disease. maintaining optimum quality of life is a major goal of care. there is a strong body of evidence that exercise can reduce or manage fatigue, depression and insomnia in breast cancer patients; however, the evidence base is overwhelmingly in early stage cancer patients. the purpose of this study is to see if a home-based, self-directed walking program can have similar benefits in women with an mbc diagnosis. the primary objective is to evaluate whether engagement in physical activity will reduce fatigue during active treatment for mbc (baseline to 3 months); this is the primary endpoint. secondary objectives pertain to feasibility of recruitment and retention of study participants and measuring changes between baseline, 3 months and 6 months in additional quality of life measures. exploratory analyses pertain to changes in p16ink4a levels and sarcopenia between baseline and 3 months. the design is a single arm intervention trial in 30 patients. findings from this study will provide preliminary data for a grant application to test the physical activity intervention in a randomized controlled trial (rct) in a large sample of women with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * female * age 21 or older * metastatic breast cancer (mbc) diagnosis - stage iv * receiving treatment regimen for mbc, but no more than 3 previous chemotherapy or biologic regimens * approval from the treating clinician to engage in moderate-intensity physical activity. * patient-assessed ability to walk and engage in moderate physical activity * proficient in english. * irb approved signed written informed consent. * willing and able to do all study requirements. exclusion criteria: * one or more significant medical conditions or other issues that in the physician's judgment preclude participation in the walking intervention. * no more than 3 prior chemotherapy regimens.

Keywords: physical activity chemotherapy fatigue
phase i safety study of anti-hiv immune serum globulin (human)

Conditions: HIV Infections

Summary: to investigate the potential benefit of providing passive immunity with hyperimmune anti-hiv human serum.


Eligibility criteria:
inclusion criteria patients must have: * proof of hiv infection. * diagnosis of asymptomatic hiv infection or early aids related complex (arc) with no zidovudine (azt) or other anti-hiv therapy. or a diagnosis of aids and = or \> 3 months of azt therapy. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * hiv-induced neurological disease. * iga negative. concurrent medication: excluded: * immunomodulating agents. * steroids. * interferons. patients with the following are excluded: * active substance abuse. * use of immunomodulating drugs such as steroids or interferons. * hiv-induced neurological disease. * iga negative. required with a diagnosis of aids: * = or \> 3 months of zidovudine (azt) therapy. active substance abuse.

Keywords: acquired immunodeficiency syndrome aids-related complex immunization, passive
faecal bacteriotherapy for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the etiopathogenesis of ulcerative colitis (uc) is not fully understood. one of the theories of uc pathogenesis represents a pathological response of mucosal immunity to intestinal microbiota. potential therapeutic procedure how to affect this fact is the faecal microbiota transplantation (fmt). review of the literature on fmt suggests great potential as the treatment for uc, but two prospective controlled study that has been published yet are inconsistent. the first objective of the project is to compare the administration of fmt enema with mesalazine enema for inducing remission in patients with active left-sided uc in the form of a prospective, randomized, controlled study. the second objective is to observe changes in the intestinal microbiota during and after fmt focusing on bacterial dna sequencing to identify the bacterial species which are responsible for the effect of the fmt.


Eligibility criteria:
inclusion criteria: * left-sided ulcerative colitis \> 15cm ongoing more than 3 month * mayo score \< 10 * endoscopic mayo score ≥ 2 exclusion criteria: * anti-tnf medication in the previous 6 months * cyclosporine in the previous 4 weeks * methotrexate in the previous 2 months * prednisone \> 10mg * the real risk of colectomy in the near future * positive stool culture (salmonella, shigella, yersinia, campylobacter, pathogenic e. coli) * cmv infection * pregnancy, breastfeeding women

Keywords: feacal bacterial transplantation left-sided ulcerative colitis
a novel, non-pharmacological, intervention for the management of adhd in adolescents

Conditions: ADHD

Summary: this is a 2-month study in which eligible adhd adolescents will be provided with personalized vizo glasses

this is a pilot, open-label study of a 2-month treatment with vizo glasses. following the enrollment, the participants will go through an adjustment process where they will be fitted with a personalized pair of vizo glasses. the participants will be instructed to wear the glasses throughout the day for two months. a follow-up visit at the end of the 2-month treatment will be conducted to assess the efficacy of vizo glasses on managing adhd symptoms, using the adhd rating scale (adhd-rs) parent-report questionnaire, the behavior rating inventory of executive function (brief), the conners continuous performance test-3, and the clinical global impression-improvement (cgi-i). safety will be monitored by documentation of adverse events.

Eligibility criteria:
inclusion criteria: * documented history of primary adhd diagnosis by certified clinicians * age 12-17 y * minimum total of 24 on the parent adhd-iv rating scale (adhd-rs) * written informed consent * able and willing to complete all required ratings and assessments exclusion criteria: * any current psychiatric/neurological comorbidity (e.g., epilepsy, autism, depression, tbi, etc.), other than adhd * adhd medications (stimulants, non-stimulants, other) * undergoing neurofeedback, cognitive training

Keywords: adhd peripheral retinal stimulation non-pharmacological treatment adolescents
novel peptide vaccination for patients with advanced bladder cancer

Conditions: Bladder Cancer

Summary: the purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

dep domain containing 1(depdc1) and m phase phosphoprotein 1(mphosph1) have been identified using genome-wide expression profile analysis by the use of cdna microarray in our previous studies. we have determined the hla-a\*2402 restricted epitope peptides derived from depdc1, depdc1-9-294, and mphosph1, mphosph1-9-278. these epitopes showed strong ifn-g production when stimulated with the appropriate targets expressed the appropriate protein and hla-a\*2402. furthermore, when vaccinated these peptides, specific ctls were determined after the vaccination. therefore we focused on the safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.

Eligibility criteria:
inclusion criteria: disease characteristics 1. advanced bladder cancer which already showed resistance to standard treatments 2. protein expression of mphosph1 and depdc1 on the tumor patients characteristics 1. patients who showed resistance to standard chemotherapies or radiotherapy 2. histological diagnosis is transitional cell carcinoma 3. hla-a\*2402 4. ecog performance status of 0 to 1 5. age ≥ 20 years, ≤80 years 6. wbc≥ 2,000/mm³, ≤15000/mm³ platelet count ≥ 75000/mm³ ast, alt ≤150 iu/l total bilirubin ≤ 3.0 mg/dl creatinine ≤ 3.0 mg/dl 7. lesion of bladder cancer must express mphosph1 or depdc1 8. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breastfeeding 3. patients willing to childbearing ( refusal or inability to use effective means of contraception) 4. serious infections requiring antibiotics 5. concomitant treatment with steroids or immunosuppressing agent 6. other malignancy difficult to control. 7. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: epitope peptide ctl advanced bladder cancer vaccination advanced bladder cancer which showed resistance for standard treatments
study of predictors of failure of sulprostone treatment in postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: the investigators wish to identify potential factors predicting failure of second-line drug treatment (sulproston (nalador®)): risk factors and factors linked to a failure to take initial care for pph. a better understanding of the aggravating factors of hpp and more particularly the factors inherent to the initial care would make it possible to think of ways to improve practices.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject having given birth at hus or chu poissy saint-germain-en laye between 01/01/2019 and 31/12/2020 * subject having presented a postpartum haemorrhage treated with sulprostone * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * subject under guardianship or guardianship * subject under safeguard of justice

Keywords: postpartum haemorrhage maternal morbidity oxytocin sulprostone uterine hemorrhage obstetric labor complications
combination partner hiv testing strategies for hiv-positive and hiv-negative pregnant women

Conditions: HIV

Summary: the overall objective of this study is to evaluate whether the addition of secondary distribution hiv self-test kits to existing partner notification guidelines increases the proportion of male partners who access facility-based hiv testing services, when compared to the partner notification strategy alone

pregnant women 18 years of age or older who enter antenatal care at chipata level 1 hospital in lusaka, zambia will participate. hiv-positive and hiv-negative pregnant women will be randomized to one of two groups: partner notification alone or partner notification plus secondary distribution of hiv self-test kits. women will return to the clinic 30 days after enrollment for an exit visit during which time information about their experience with the partner notification strategies will be collected. a random sample of women and health care workers will also participate in qualitative interviews.

Eligibility criteria:
inclusion criteria * 18 years of age or older * pregnant at time of enrollment based on antenatal record * documented hiv status (either positive or negative) in antenatal record * reports at least one current sexual partner * willingness to provide her own contact information * ability and willingness to provide informed consent * intent to remain in current geographical area of residence for the duration of follow-up activities * willingness to adhere to study procedures exclusion criteria * women who express concerns about ipv or social harms as a result of participation during the screening process will not be included. * women who have previously enrolled in the study will not be permitted to enroll again.

Keywords: self testing partner notification secondary distribution