Kornimate/medical-research-clean huggingface dataset:
mesenchymal stem cell therapy of dry eye disease in patients with sjögren's syndrome

Conditions: Keratoconjunctivitis Sicca, in Sjogren's Syndrome

Summary: amass is a double-blinded randomized clinical trial with the purpose of investigating whether injection of allogeneic adipose-derived mesenchymal stem cells (ascs) into the lacrimal gland (lg) results in increased ocular comfort compared to placebo.

amass is a double-blinded randomized clinical trial which will be performed at the department of ophthalmology, university hospital of copenhagen, denmark. 40 patients with severe aqueous deficient dry eye disease (adde) due to sjögren's syndrome (ss) will be recruited from the dept. of ophthalmology, rigshospitalet, and allocated in ratio 1:1 to either injection of allogeneic adipose-derived mesenchymal stem cells (ascs) or placebo (vehicle, crystore cs10) into the lacrimal gland (lg) in one eye. we hypothesize that injection of allogeneic ascs into the lg increases tear production and reduce inflammation resulting in increased ocular comfort compared to placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of sjögren's syndrome according to the 2016 american college of rheumatology/european league against rheumatism classification criteria for primary sjögren's syndrome * osdi-score ≥ 33 * schirmer's test 1-5 mm/5 minutes * nikbut \< 10 sec exclusion criteria: * lg volume on mri \< 0,2 cm3 in the study eye * previous treatment with ascs or other stem cell products in the lg(s) * reduced immune response (e.g. hiv positive) * pregnancy or planned pregnancy within the next 2 years * breastfeeding * topical treatment with eye drops other than to treat dry eye disease (ded) * any other disease/condition judged by the investigator to be grounds for exclusion, such as infection in or around the eye
a study of irinotecan with dabrafenib plus trametinib and anti-egfr in the second line of therapy in people with metastatic colorectal cancer

Conditions: Neoplasms

Summary: the purpose of this study is to evaluate the efficacy and toxicity of irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the braf gene. participants in this study will receive one of the following study treatments: these participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab. this trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second line of therapy. the study team will monitor how each participant responds to the study treatment for up to about 3 years.

the purpose of the study is to evaluate the efficacy and toxicity of irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metastatic inoperable colorectal cancer who have a braf mutation.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed metastatic inoperable colorectal adenocarcinoma 2. the tumour has a braf mutation 3. adequate function of hematopoiesis and basic indicators of internal organs 4. has measurable or evaluable disease according to response evaluation criteria in solid tumors (recist v1.1). 5. absence of grade 2 or higher toxicity from previous line of treatment. 6. it is possible to include patients with msi or dmmr if they have received first-line immune checkpoint therapy. 7. ecog ps 0-1 exclusion criteria: 1. participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable). 2. presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment. 3. pregnant and breastfeeding women. 4. male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study. 5. hiv-infected patients. 6. patients with a life expectancy of less than 3 months. 7. the presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.

Keywords: metastatic colorectal cancer braf v600e- mutated treatment
risk assessment tool for graft survival in pediatric kidney transplantation

Conditions: Kidney Transplant Failure and Rejection; Pediatric Kidney Disease

Summary: registry study in which data of all pediatric kidney recipients in the netherlands (registered in the nederlandse orgaan transplantatie registry) are studied to develop a risk calculator for graft loss.

the pre-transplantation parameters of all recipients are used to do a multivariable regression analysis. the b-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.

Eligibility criteria:
inclusion criteria: pediatric kidney recipients * transplantation in the netherlands * signed informed consent exclusion criteria: * combined transplantation (pancreas-kidney of liver-kidney transplantation) * no informed consent
dual energy computerized tomography (de-ct) in patients with crohn's disease

Conditions: Crohn's Disease

Summary: this study aims to evaluate the accuracy of dual energy computerized tomography (de-ct) in predicting the need for surgery in patients with crohn's disease and intestinal lesions with obstructive symptoms. patients with known crohn's disease which were scheduled to perform abdominal ct for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. de-ct parameters were then compared between patients who underwent surgery and those who did not.

introduction intestinal strictures are common in patients with crohn's (cd) disease and may result in intestinal obstruction. current available imaging studies can usually identify and locate the stricture, but can not reliably differentiate the patients who will require surgery from those who will respond to medical therapy. dual energy computerized tomography (de-ct) uses two energy sources using high and low tube voltage, thus creating two data sets. dedicated software creates overlay of the low and high energy images, in which enhancement of tissues with iodine can be better appreciated and quantified compared to standard ct. the investigators hypothesize that dual energy can better visualize the iodine uptake in bowl wall as a marker of inflammation within intestinal lesions, and may help in identifying the patients who will or will not require surgery. aim to evaluate the efficacy of de-ct studies in predicting need for surgery within 3 months. methods patients with known cd undergoing abdominal ct for possible obstructive presentation prospectively underwent a de-ct using intravenous iodinated contrast material, and were followed for 3 months for an outcome of surgery. the de-ct was interpreted by a radiologist blinded to the clinical outcome, and the attending physicians of the patients were blinded to the interpretation of the de-ct. de-ct parameters were then compared between patients who underwent surgery and those who did not. receiver operating characteristic (roc) curve analysis was used to find the optimal cut off point to distinguish between patients which did or did not eventually underwent surgery. based on the cut off points found from the roc analysis, the negative and positive predictive values were calculated.

Eligibility criteria:
inclusion criteria: * age over 18 years, * known crohn's disease (at least 3 moths prior) * obstructive symptoms * scheduled for abdominal ct for evaluation of symptoms (regardless of participation in the study) exclusion criteria: * pregnancy * contraindication to perform ct with iv contrast media
pharmacist guided pre-emptive pharmacogenetic testing in antidepressant therapy

Conditions: Depression

Summary: in this study at the solothurn psychiatric clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. in the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. in the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. if after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. the drugs used are all approved in switzerland for the treatment of depression. classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. the probability of allocation to one of the two study groups is 50%. all study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. in total, it is planned to include and examine 95 patients each into the intervention and standard group.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (icd10: f32.1/32.2/33.1/33.2) * ham-d17 ≥ 17 exclusion criteria: * acute suicide risk * psychotic symptomatology * other acute serious psychiatric disorder other than depression * excessive consumption of alcohol and/or drugs * severe acute - or severe chronic somatic diseases * pregnant / lactating women * under current treatment with fluoxetine
development and assessment of a mobile phone based intervention to reduce maternal depression and improve child health

Conditions: Maternal Depression

Summary: the prevalence rate of maternal depression in pakistani women and its effect on the growth and development of young children and child mortality is very high. the main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. the study will be a 2 (conditions) into 3 (time) single blind randomized controlled trail. depressed mothers will be randomized either to intervention arm or control arm. intervention will include text messages based on learning through play plus (ltp plus cbt).

disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. there are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance. the proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as pakistan. participants will be recruited from maternal and child care centres in karachi, pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. intervention will be comprised of ltp plus and will be delivered through text messages. momentary sampling assessment and momentary psychological intervention will be part of this study. participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.

Eligibility criteria:
inclusion criteria: * mothers with mild to moderate depression will be included * mother of children age 0-30months * the age range in the study is 18 to 44 years * participants having mobile phones will be included exclusion criteria: * subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability * any form of psychosis, or are currently under psychiatric care. * mothers with severe depression or suicidal ideation will not be included * mothers who will be receiving any psychological intervention will be excluded * mothers of children with any serious medical or psychiatric illness will also be excluded.

Keywords: maternal depression mobile phone based intervention learning through play cbt intelligent real time therapy
a double-blind placebo-controlled trial of rozerem in migraine headaches

Conditions: Migraine Headache

Summary: to study the effect of rozerem, a high affinity mt1 and mt2, low affinity 5-ht2b receptor agonist used for insomnia, as a migraine prophylactic agent.

in a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. those who had shorter average sleep times reported more severe headaches. poor sleep has been associated with increased frequency and severity of migraines. the improvement of migraine frequency with improved sleep hygiene has been documented. pet imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. polysomnography has shown specific headache types to occur in specific sleep stages. melatonin has been effective primarily in headache due to delayed sleep phase syndrome. recent studies support the efficacy of melatonin in treating migraine. the purpose of this study is to examine the efficacy of rozerem as a prophylactic migraine medication. if effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep. hypothesis: rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.

Eligibility criteria:
inclusion criteria: * age 18-65 * 3-8 migraine headaches/month * able to understand and comply with the study exclusion criteria: * currently on migraine prophylaxis * currently on sleep medication \> 4days/month * currently on fluvoxamine * untreated psychiatric or sleep disorders * mri abnormalities other than those attributable to migraine headaches * abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep * known disorders of prolactin * bipolar disorder * hepatic disease * pregnancy

Keywords: migraine headache
hydralazine and valproate added to chemotherapy for breast cancer

Conditions: Locally Advanced Breast Cancer

Summary: aberrant dna methylation and histone deacetylation participate in cancer development and progression, as epigenetic alterations are common to breast cancer, in this phase ii study, the demethylating hydralazine plus the hdac inhibitor magnesium valproate will be added to neoadjuvant doxorubicin and cyclophosphamide in locally advanced breast cancer to assess their safety and biological efficacy.

eligible patients after signing the informed consent and will undergo study evaluation and then typed for acetylator phenotype before being treated with hydralazine at 182 mg for rapid-, or 83 mg for slow-acetylators, and magnesium valproate at 30 mg/kg, starting from day -7 until chemotherapy ends. chemotherapy will consists in a regimen of four cycles of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 21 days, followed by surgery to assess the pathological response. adjuvant radiation and additional treatment will be done in off-protocol basis according to standard institutional policies. blood samples and core-needle biopsies will be taken from primary breast tumors at diagnosis and at day 8 of treatment with hydralazine and valproate. global cytosine content (global dna methylation) and histone deacetylase activity will be assessed in peripheral blood dna. the transcriptional profile in the primary breast tumor before and after treatment will also be analyzed as well as the plasma levels of hydralazine and valproic acid.

Eligibility criteria:
inclusion criteria: aged 18 and older; histologically proven invasive t2-3, n0-2, and m0 (stages iib-iiia) breast carcinoma; eastern cooperative oncology group performance status ≤2. hematological function: absolute leukocyte count ≥4,000/mm3, platelets ≥100,000/mm3, hemoglobin ≥9.0 g/dl. hepatic function: total bilirubin, aspartate amino transferase and alanine amino transferase \<1.5 the upper normal limit. renal function: creatinine ≤1.2 mg/dl or a calculated creatinine clearance of ≥60 ml/min. written informed consent. exclusion criteria: a history of allergy to sulphas, hydralazine, or magnesium valproate. past or present condition of rheumatic disease, central nervous system disease, heart failure from aortic stenosis and postural hypotension as diagnosed by a physician. previous use of the experimental drugs. pregnancy and breast-feeding. uncontrolled systemic disease or infection.

Keywords: locally advanced breast cancer hydralazine magnesium valproate epigenetic therapy gene expression
time and motion study for ocrelizumab and ofatumumab administration in relapsing multiple sclerosis

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: this is an observational cross-sectional study of ocrelizumab or ofatumumab administrations for relapsing forms of multiple sclerosis (rms) in selected sites in the us, the uk and australia.

patients with rms receiving ocrelizumab or ofatumumab will be recruited to measure the time spend for healthcare providers (hcp) (neurologist, nurse and hospital pharmacist) on preparing, administering the medication and following up with the patient.

Eligibility criteria:
inclusion criteria: * adult patients of 18 or more years of age. * patients with confirmed diagnosis of rms (cis, rrms or aspms) following 2017 mcdonnald criteria. * patients currently prescribed with ocrelizumab or ofatumumab to treat ms according to the summary of product characteristics (smpc). the decision must be based on patient disease and taken before the decision of inviting the patient to participate in this study. * patients literate in english. * patients must provide informed consent to participate in the study. exclusion criteria: * patients currently participating in any other rms clinical trial.

Keywords: relapsing forms of multiple sclerosis rms ocrelizumab ofatumumab timios
desmopressin in the treatment of mixed nocturia with nocturnal polyuria and low nocturnal bladder capacity

Conditions: Nocturia

Summary: nocturia is defined as waking one or more times to void during the period between going to bed with the intention of sleeping and waking with the intention of arising.the pathophysiology of nocturia is multifactorial and can be complex. therefore it is important to adopt a systematic approach to identify the possible causal factors of nocturia and to treat them accordingly. patients with nocturia can be categorized as having one of the following three disorders: (1) nocturnal polyuria (np) in which the voided urine volume during the hours of sleep exceeds 35% of the 24-hr output, (2) low nocturnal bladder capacity (nbc) causing a nocturnal urinary volume greater than the bladder capacity, (3) or mixed nocturia, a combination of the preceding two categories. desmopressin, a synthetic analogue of the antidiuretic hormone (adh), has been used for many years to treat diabetes insipidus and primary nocturnal enuresis.more recently, it is also known to be effective against nocturia with np by decreasing night-time urine production.however, it may be associated with an increased risk of developing hyponatremia due to water retention, especially in elderly patients.in the present study, we investigated the safety and efficacy of oral desmopressin for the treatment of mixed nocturia in patients with both np and a low nbc.

1. open label, prospective, multicenter study 2. study design * screening (1-week), dose titration (1-3 weeks) and 4-weeks of treatment period * open-label dose-titration periods of up to 3 wk; the patients' optimum oral desmopressin dose (0.1, 0.2 and 0.4 mg) was determined as the dose that decreased the number of nocturnal voids by ≥50% and nuv decreased by ≥20% without hyponatremia. * if the patients did not meet the above criteria during dose titration period, they received the maximum tolerable dose instead of the optimum dose. -- 4-weeks of treatment period; eligible patients were treated with the determined optimum desmopressin dose for 4-weeks. 3. measurements * 3-day frequency-volume charts * sleep questionnaire * body weight, blood and urine analysis,serum sodium monitoring * adverse event

Eligibility criteria:
inclusion criteria: * aged ≥18 yr * nocturia ≥2 voids/night * nocturnal polyuria index (npi) \>33% * nocturnal bladder capacity index (nbci) \>1 exclusion criteria: * nocturia due to other defined causes of increased urinary frequency * primary polydipsia (\>40ml/kg/24 h) * neurogenic bladder dysfunction * significant bladder outlet obstruction * urge incontinence * continued post-voiding residual urine \>150ml * serum sodium levels \<135mmol/l * uncontrolled hypertension characterized by fluid and/or electrolyte imbalance * use of diuretics * actual or planned pregnancy

Keywords: nocturnal polyuria nocturnal bladder capacity
an observational study of mircera in renal anemia correction in dialysed patients during daily clinical practice

Conditions: Anemia

Summary: this observational, multi-center study will evaluate the efficacy and safety of mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. patient will receive mircera according to local summary of product characteristics. data will be collected for 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * adequate iron status * signed informed consent form exclusion criteria: * anemia due to non-renal causes * where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer) * pregnant or lactating female patients * any contraindications against treatment with mircera (according to local summary of product characteristics)