Kornimate/medical-research-clean huggingface dataset:
take off pounds after stroke trial (tops)

Conditions: Stroke; Obesity; Overweight; Hemiparesis

Summary: the take off pounds after stroke (tops) trial is a prospective randomized open-label blinded endpoint (probe) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (bmi) following a recent ischemic stroke.

the tops trial is designed as a probe study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, in achieving clinically significant weight loss without impairment of physical function when initiated within 90 days following ischemic stroke in patients with bmi 27-to-49.9 kg/m2. participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet intervention) or enhanced standard care (control) with randomization stratified by recruitment center (bidmc, yale) and baseline diet consistency status (modified consistency diet vs regular consistency diet). baseline diet consistency status was selected as a stratification factor because it is expected that patients with difficulty swallowing (dysphagia) after stroke that results in need for modifications to food/liquids will have a different weight loss trajectory than patients who are able to safely consume a regular diet. the follow-up duration will be 12 weeks for all subjects.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke within 90 days of randomization 2. age \>=18 3. bmi 27-49.9 mg/kg2 4. able to meet all nutritional and fluid needs by oral intake. 5. ready to undergo behavioral change 6. able and willing to provide written informed consent 7. maximum weight \<=350 lbs exclusion criteria: 1. medical contraindication to weight loss or diet, including the following: renal disease requiring dialysis, taking lithium, or end stage liver or renal disease considered incompatible with diet intervention by patient's personal healthcare provider or the study pi 2. enrollment in a conflicting clinical trial (defined as a trial with an intervention known to affect weight or with an exclusion for participation in another trial) 3. pregnancy or desire to become pregnant, or currently breastfeeding 4. high-risk of malnutrition using a standard screen 5. trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months preceding screening) 6. allergy to soy based food products 7. require thickening of liquids due to dysphagia 8. inability to communicate with study team 9. inability to speak english 10. irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)
pilot study of single dose bevacizumab as treatment for acute respiratory distress syndrome (ards) in covid-19 patients

Conditions: ARDS, Human; Coronavirus Infection

Summary: our hypothesis is that treating ards caused by covid-19 with bevacizumab improves mortality. this is a phase ii, multi-centered, randomized, open label, two-armed clinical trial to study the safety and efficacy of bevacizumab in covid-19 positive patients who consequently developed ards (acute respiratory distress syndrome) and who have previously received anti-viral and anti-inflammatory treatment.

the vascular endothelial growth factor (vegf) improves vascular capillarity, which plays an important role in the uncontrolled inflammatory reaction that happens in ards. as opposed to this event, angiogenic therapy (like bevacizumab) is known to contribute to normal vascularization, relevant for regaining vascular permeability. studies in animal models have shown that treating ards with anti-vegf therapy is effective.

Eligibility criteria:
inclusion criteria: * age equal or over 18 and under 90 years old. * confirmed covid-19 positive diagnostic through pcr. * radiological image compatible with non-cardiogenic bilateral pleuropulmonary exudate. * patient has received anti-viral and anti-inflammatory therapy. * present any of the following clinical-functional criteria: 1. respiratory distress: tachypnea\> 30 breaths / minute 2. partial arterial oxygen pressure (pao2) / fraction of inspiration (fio2) ≤ 300 mmhg * signed informed consent, directly or delegated. exclusion criteria: * severe liver dysfunction (child pugh ≥ 3 or ast\> 5 times normal) * severe renal dysfunction with glomerular filtration \<30 ml / minute or under treatment with hemodialysis or peritoneal dialysis. * poorly controlled hypertension (bps\> 160 mmhg or tad \<100 mmhg) or having a history previous hypertensive crisis or hypertensive encephalopathy. * history of poorly controlled heart disease with a nyha\> 2. * history of thrombosis in the previous 6 months. * signs of active bleeding. * open wounds, gastrointestinal perforation. * diagnosis of thrombophilic diseases or hemorrhagic diathesis. * active viral hepatitis or hiv not properly treated. * intolerance or allergy to bevacizumab or its components. * pregnancy.

Keywords: ards sars-cov-2 bevacizumab
pioglitazone tablets special drug use surveillance "combined use of biguanides / long-term treatment"

Conditions: Type 2 Diabetes Mellitus

Summary: to investigate the safety and efficacy of long-term treatment with pioglitazone (actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus.

this is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000). the usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast. dose adjustment will be made according to gender, age, and symptoms with an upper limit of 45 mg.

Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy 2. patients with available hba1c data within the 1 month prior to the start of actos tablets treatment 3. patients likely to be available for a 12-month observation after the start of actos tablets treatment exclusion criteria: 1. patients who have received actos tablets within the past 3 months. 2. patients who started treatment with biguanides and actos tablets simultaneously 3. patients who discontinued biguanides and switched to actos tablets treatment. 4. patients who received additional biguanides after the start of actos tablets treatment 5. patients with contraindications to actos tablets treatment

Keywords: drug therapy
maudsley model of anorexia nervosa treatment for adolescents and young adults (mantr-a)

Conditions: Anorexia Nervosa; Anorexia

Summary: the aim of this study is to test effectiveness of a new treatment program for adolescents and young adults within the age of 14-21 suffering from an (mantr-a) compared to treatment as usual (tau).

anorexia nervosa (an) is a serious mental illness which leads untreated to aggravation of symptomatology and chronification. among all mental illnesses, an has the highest mortality rate, which is about 5.1 per 1000 people per year. high drop-out rates (up to 40%) or small treatment motivation constrains treatment success. since the onset of an is mainly in adolescence, it is important to start with therapy as early as possible and establish an effective single-setting treatment program for this age group to prevent chronification. mantr-a (maudsley model of anorexia nervosa treatment for adolescents) is an innovative, theory-based, tailored treatment program which combines a cognitive behavioural approach with motivational interviewing. the main focus of the treatment program is the transformation maintaining factors of an, like personality aspects, pro-anorexic beliefs, emotion regulation strategies, thinking styles and obstructive behaviour from caregivers. the aim of this study is the examination ot the effectiveness of the mantr-a treatment program for adolescents and young adults. therefore we compare mantr-a (intervention group) with treatment as usual (control group). assessments will be conducted before treatment (t0, baseline), after six months (t1), after 12 months (t2) and after 18 months (t3, follow-up) via questionnaires, interviews and neuropsychological measurements. process evaluation takes place after every session. each group consists of female adolescents and young adults within the age of 14-21 suffering from an (icd-10: f50.0, f50.1), resulting in an overall sample size of 100. the long-term goal of the study is to provide an evidence-based outpatient treatment for children and adolescents with an in order to prevent a chronic course of the disease.

Eligibility criteria:
inclusion criteria: * icd-10 diagnosis of anorexia nervosa (f50.0) or atypical anorexia nervosa (f50.1). exclusion criteria: * life-threatening an requiring immediate inpatient treatment as defined by nice (2017) * insufficient cognitive ability * insufficient knowledge of german language to understand the treatment * severe mental or physical illness that needs treatment on its own (e.g. psychosis) * substance abuse * pregnancy

Keywords: treatment psychotherapy young adult adolescence
effect of intravaginal prasterone on symptoms of genitourinary syndrome of menopause (gsm) in women in menopause with previous breast cancer

Conditions: Women With Breast Cancer

Summary: the goal of this interventional study is to evaluate the effect of intravaginal prasterone for the treatment of moderate to severe symptoms of genitourinary syndrome (gsm) due to natural, surgical or treatment-induced menopause and the effect on the quality of life, including sexual function and mood well-being, in women with breast cancer. a sample size of 95 patients will be needed to show that the proportion of women showing symptom improvement is greater than 50%. subjects will be followed up at four weeks and twelve weeks of treatment. one and three-month outcomes will be provided after the end of treatment. comparison between menopausal women with previous breast cancer that have finished hormonal therapy or with er negative breast cancer and women currently under endocrine therapy with ais will be performed.


Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer, completely excised * natural or iatrogenic menopausal status * no evidence of distant metastasis * self-identified moderate to severe symptoms of genitourinary syndrome * normal kidney and liver function * written informed consent signed and dated by patient * negative papanicolau (pap) smear cytology test within 1 year prior to enrollment exclusion criteria: * vaginal or uterine bleeding of unknown origin * current diagnosis of any non-breast malignancy * metastatic disease * currently on chemiotherapy * currently on treatment with tamoxifen * mentally incompetent or evidence of active substance or alcohol abuse * endometrial hyperplasia * pregnancy or lactation * currently use of other vaginal therapy for the same purpose (if present, they have to be stopped 15 days before baseline visit) * clinically significant metabolic or endocrine disease not controlled by medication

Keywords: genitourinary syndrome prasterone breast cancer
treating chronic pouchitis with a low fodmap diet

Conditions: Pouchitis

Summary: we aim to determine whether low fodmap diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. shortly after their screening visit, patients will be randomized 1:1 to either the low fodmap diet (experimental) or regular diet (control) group. patients in the experimental group will schedule a telephone visit with a registered dietician. during this approximately hour-long session, patients in the low fodmap cohort will be counseled regarding fodmap containing foods. they will be asked to adhere to this diet over the next 6 weeks. at the end of the 6 week period, subjects will complete a 3-day food diary. those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. at the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.

Eligibility criteria:
inclusion criteria * patients aged 18-65 with a diagnosis of ulcerative colitis that have undergone ileal pouch-anal anastomosis following proctocolectomy for medication-refractory disease * either ≥4 episodes of pouchitis per year (antibiotic-dependent) or persistent symptoms despite 4 weeks of antibiotic therapy (antibiotic-resistant) exclusion criteria * diagnosis of indeterminate colitis or crohn's disease * celiac disease * current use of low fodmap diet * known dietary allergies * current use of antibiotics for reasons other than treatment of pouchitis * clostridium difficile infection * complication following ileal pouch-anal anastomosis requiring reoperation

Keywords: low fodmap diet pouchitis
biib023 proof-of-concept study in participants with lupus nephritis

Conditions: Lupus Nephritis

Summary: the primary objective of the study is to assess the efficacy of biib023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. the secondary objectives of this study are to assess the safety and tolerability of biib023 compared with placebo in this study population.

participants who complete this study through week 52 will be offered the option to enter an extension study under a separate protocol 211le202 (nct0193089).

Eligibility criteria:
key inclusion criteria: * documented diagnosis of systemic lupus erythematosus (sle) according to current american college of rheumatology (acr) criteria. at least 4 acr criteria must be documented, 1 of which must be a positive antinuclear antibody (ana), anti sm, or anti dsdna antibody. * diagnosis of international society of nephrology/renal pathology society (isn/rps) 2003 class iii or iv lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to screening. participants are permitted to have co existing class v lupus nephritis. if a renal biopsy has not been performed within 3 months of the screening visit, one can be performed during the screening period after all other eligibility criteria have been confirmed. the local histological diagnosis must be confirmed by the central study pathologist. * must have proteinuria at screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (upcr) \>1.0 mg/mg. key exclusion criteria: * retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from sle at screening * estimated glomerular filtration rate (egfr) \<30 ml/min per 1.73 m\^2 (calculated using the abbreviated modification of diet in renal disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation * subjects requiring dialysis within 12 months prior to screening * history of renal transplant * treatment with any biologic b-cell-depleting therapy (e.g., anti-cd20 \[rituximab\], anti-cd22 \[epratuzumab\], anti-blys/b-cell activating factor \[e.g., briobacept, belimumab\] therapy), or taci-ig within 12 months prior to run-in day 1. note: other protocol defined inclusion/exclusion criteria may apply.
effectiveness of cftr modulators according to co-therapy

Conditions: Cystic Fibrosis

Summary: unless cftr modulators are highly effective, the introduction of cftr (cystic fibrosis transmembrane conductance regulator) modulators could lead to concomitant reduction or discontinuation of respiratory co-therapies in real-life. such reduction/discontinuation of respiratory co-therapies could lead to an overall decrease of the effectiveness of cf care. moduco study aims: 1) to compare the clinical effectiveness on lung function and pulmonary exacerbation of cftr modulator during the year of initiation, according to level of co-therapy among cf patients; 2) to describe the nature and level of respiratory co-therapies (azithromycin, rhdnase, inhaled antibiotics) in the year before the initiation of cftr modulator; 3) to describe the changes in respiratory co-therapies during the first and the second year following the initiation of cftr modulator and compare between the two cftr modulators; 4) to describe adherence to cftr modulator during the first and the second year following its initiation; 5) to study the association between the nature of respiratory co-therapies and adherence to cftr modulator during the first and the second year following its initiation. a national population-based comparative effectiveness study will be conducted, based on retrospective analysis of clinical and prescription data of the french cf registry linked with the french national health data system (snds).


Eligibility criteria:
inclusion criteria: * - cf patients aged 6 years and more, * treated at least 6 months by ivacaftor or lumacaftor/ivacaftor or elexacaftor/tezacaftor/ivacaftor, * included in the french cf registry, * for whom probabilistic matching with the snds database has succeeded. exclusion criteria: * none

Keywords: cystic fibrosis cftr modulators co-therapy snds
cardiovascular risk assesment in diabetic patients via lens autofluorecscence detection

Conditions: Diabetic Patients With/Without Atherosclerotic Diseases

Summary: the rate of lens autofluorescence will be compared in diabetic and non diabetic patients with/without atherosclerotic vascular diseases to evaluate if it is associated with the risk of cardiovascular diseases.

the rate of lens autofluorescensce is associated with the accumulation of advanced glication endproducts (age).the concetration of age increases with age but is also higher in diabetic patients. there is evidence that diabetes could be diagnosed via the detection of lens autofluorescence. the investigators are planning a cross sectional clinical trial to evaluate if the rate of lens autofluorescence could be associated with the clinical appearance of atherosclerotic vascular diseases in diabetic/non-diabetic patients and in patients who already had atherosclerotic vascular events and patients without previous atherosclerotic events. the cardiovascular and metabolic histoty of patients will be evaluated using a questionaire. antropometrical data, blood pressure, heart rate, glucose metabolism, serum lipid profile, crp, serum creatinine (egfr) will be assased. clearpath ds-120 biomicroscopical optical system (freedom meditech, san diego, ca, usa) will be used for the measurment of lens autofluorescence. the measurement will be performed on one eye. data of the different patient groups will be compared using anova, a value of p\<0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years either wit type 2 diabetes or non-diabetic, either having atherosclerotic vascular events in history or not (acs, angina pectoris, stroke, tia, clinically symptomatic pad, atherosclerosis based amputation, stent implantation, angiplasty) diabetes present for more than 1 year. exclusion criteria: * patient did not signe informed consent * cataract * after cataract operation, after optical operation, after sclera injury * fluorescein angiograpy performed in 6 months * diseases affecting the eye surface( sleritis, sjogren sy)

Keywords: diabetes mellitus atherosclerosis age lens autofluorescence
cytokine assay for early identification of pediatric stem cell transplant recipients

Conditions: Blood Stem Cell Transplant Failure

Summary: the aim of our study is to determine whether a clinically relevant laboratory measurement (of seven specific immunologic biochemicals in the blood) can identify which bone marrow transplant recipients are likely to progress to respiratory failure. our ultimate goal is to devise a comprehensive and inclusive laboratory test that is effective at determining who is likely to go on to respiratory failure, in order to facilitate early medical intervention.


Eligibility criteria:
inclusion criteria:- hematopoietic stem cell transplantation (hsct) for any indication. * patients will range from age 0 to age 21. there is no gender restriction. we expect the male to female ratio to end up being about 50/50 * ability to understand and the willingness to sign a written informed consent document.
dynamic alterations of tongue in sleep apnoea hypopnea syndrome during sleep

Conditions: Obstructive Sleep Apnoea

Summary: the aim of this study was to evaluate the dynamic changes of the tongue in patients with obstructive sleep apnoea hypopnea syndrome (osahs) during sleep and while awake by using ultrafast magnetic resonance imaging (umri)

umri was undertaken on the upper airway in 21 osahs patients and 20 normal people after being deprived of sleep for one night. a series of midline sagittal images of the upper airway were obtained. the dynamic alterations of the tongue size and the distance from the tongue to x axis (an extended line from the anterior nasal spine to posterior nasal spine) and y axis (a perpendicular line from the center of the pituitary to the x axis) were measured.statistical comparisons between pairs of means were performed via t-tests using spss10 software. a probability level of p\<0.05 was considered to be statistically significant.

Eligibility criteria:
inclusion criteria: 1. patients who are male 2. patients were diagnosed as osahs 3. patients underwent a thorough history (including the epworth somnolence questionnaire) and physical examination 4. patients did not undergo any treatment 5. each subject gave written informed consent before entering the study. exclusion criteria: 1. patients didn't sign written informed consent 2. any situation or condition that will interfere with adherence to study activities

Keywords: obstructive sleep apnoea tongue alteration
chagas disease as an undiagnosed type of cardiomyopathy in the united states

Conditions: Heart Diseases; Myocardial Diseases; Chagas Disease

Summary: a detailed review was made of data pertinent to the occurrence of chronic chagas disease in the united states.

background: in latin america, 16 to 18 million individuals are thought to have chagas' disease and 90 million are considered to be at risk of infection. in the united states, the occurrence of chagas' disease is virtually limited to individuals who have resided in latin america where they acquired the infection, and then migrated to this country. design narrative: data on the prevalence of positive serologic reactions for trypanosoma cruzi (a protozoan causing chagas cardiomyopathy) serve for calculating that a total of up to 74,000 latin americans residing in the united states have the chronic form of chagasic cardiomyopathy. the vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. vector transmission of t. cruzi infection is very unlikely to occur in the united states because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the united states. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria