Kornimate/medical-research-clean huggingface dataset:
evaluate the effect of alln-177 in reducing urinary oxalate in patients with secondary hyperoxaluria and kidney stones over 28 days

Conditions: Secondary Hyperoxaluria; Nephrolithiasis; Hyperoxaluria; Kidney Stones; Dietary Hyperoxaluria

Summary: evaluate the safety, tolerability, and efficacy of 28 days of treatment with alln-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.

this is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of alln 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. alln-177 is an orally administered form of oxalate decarboxylase. the goal of therapy with alln-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract. eligible subjects will be randomized to 28 days of treatment with alln-177 (7,500 units) or placebo three times daily with meals. urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. the study allows for approximately 66 subjects. the number of enrolled subjects may be increased to a maximum of 100 following an interim analysis.

Eligibility criteria:
inclusion criteria: * history of enteric or idiopathic hyperoxaluria or kidney stones * urinary oxalate ≥ 50 mg/24 hours exclusion criteria: * hyperuricosuria * glomerular filtration rate \< 45 ml/min/1.73m2 * hypercalcemia or hyperthyroidism * autoimmune disorder requiring systemic steroids * acute renal colic, primary hyperoxaluria, pure uric acid and/or cysteine stones, renal tubular acidosis, chronic urinary tract infection, or acute renal failure

Keywords: urine oxalate nephrolithiasis kidney stones hyperoxaluria enteric hyperoxaluria idiopathic hyperoxaluria urological diseases kidney diseases supersaturation dietary oxalate
surgical intervention for morbidly obese adolescents

Conditions: Obesity; Diabetes; Hypertension

Summary: the purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated. our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.

severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. there is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. i. e. most of the subjects having a bmi \>40kg/m2 in the adolescence will remain morbidly obese also in their adult life. the three largest centres in sweden treating obese children (stockholm, gothenburg and malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. if not willing to be operated they could join the study as a control case. subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. they will subsequently be follow over a ten year period regarding these variables.

Eligibility criteria:
inclusion criteria: * bmi \>40 kg/m2 or bmi\>35 with comorbidity * pass psychological evaluation * puberty status tanner 4-5 * at least one year with active conservative treatment that failed exclusion criteria: * lack of compliance * specific obesity syndrome as praeder willis * obesity due to brain injury * severe general disease * specific genetic defect (mc4r, leptin deficiency)

Keywords: obesity surgery adolescent roux-en-y gastric bypass laparoscopic
manualised cognitive behavioral therapy of anxiety disorders in children and adolescents in routine care setting

Conditions: Anxiety Disorders

Summary: manualised cognitive behavioral therapy for children and adolescents with anxiety disorders is evaluated in a routine care setting to evaluate the efficacy of the intervention. children and adolescents receive manualized cognitive behavioral therapy for anxiety disorder. it is expected, that the intervention will result in less anxiety / lower scores on the primary and secondary outcome measures.


Eligibility criteria:
inclusion criteria: * children and adolescents aged 4-18 years * primary diagnosis of an anxiety disorder: 1. generalized anxiety disorder 2. social phobia 3. separation anxiety disorder 4. panic disorder +/- agoraphobia 5. specific phobia exclusion criteria: * other primary diagnoses * significant intellectual impairment

Keywords: diagnostic and statistical manual of mental disorders-iv/-5: anxiety disorders in children
renal denervation on quality of 24-hr bp control by ultrasound in resistant hypertension

Conditions: Hypertension; Vascular Diseases

Summary: the require study is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of prds-001 (recor medical inc. paradise in europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.

patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.

Eligibility criteria:
inclusion criteria: * average office systolic bp of 150 mmhg or greater or office diastolic bp of 90 mmhg or greater (both in the sitting position) * 24-hr ambulatory bp 140 mmhg or greater. exclusion criteria: * secondary hypertension (sleep apnoea can be included.) * type i diabetes or uncontrolled type ii diabetes with hba1c 8.4% or greater * known or concurrent chronic active inflammatory bowel diseases (e.g. crohn's disease, ulcerative colitis etc.) * egfr\<40 ml/min/1.73m2 (per predictive equation japanese society of nephrology) * known severe cardiovascular events within 3 months or severe cerebrovascular events * patients those who are planned to receive pci or other operation for iscaemic cardiovascular disease within 8 months * concurrent persistent atrial fibrillation * patients those who are on active implantable medical devices * primary pulmonary hypertension * patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media

Keywords: denervation resistant hypertension
biomarker sub study of the compression stockings to prevent the post-thrombotic syndrome (sox) trial

Conditions: Deep Venous Thrombosis

Summary: the purpose of this study is to evaluate whether biomarkers of inflammation, genetic thrombophilia and coagulation activation influence post-thrombotic syndrome development in patients with symptomatic proximal deep venous thrombosis.

the post-thrombotic syndrome (pts) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (dvt). affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. poor understanding of the pathophysiology and predictors of pts has hampered progress in its prevention and treatment. biomarkers reflective of inflammation, genetic thrombophilia and coagulation activation may be of value in predicting pts development in patients with dvt; they may also provide insight into understanding the underlying mechanisms of pts, which could result in the development and testing of novel therapies to prevent and treat pts.

Eligibility criteria:
inclusion criteria: * consecutive patients with a first, symptomatic, objectively confirmed proximal dvt diagnosed within the last 14 days (with or without concurrent distal dvt or pulmonary embolism) * who have no contraindications to standard treatment with heparin and/or warfarin, and * who provide informed consent to participate exclusion criteria: * contraindication to compression stockings limited lifespan (estimated \< 6 months) * geographic inaccessibility preventing return for follow-up visits * inability to apply stockings daily and unavailability of a caregiver to apply stockings daily * treatment of acute dvt with thrombolytic agents

Keywords: postphlebitic syndrome post-thrombotic syndrome biomarkers markers of inflammation genetic thrombophilia coagulation activation
effectiveness of play-based training on executive functioning in pre-school children

Conditions: Executive Function; Problem Behavior

Summary: the aim of this study is to examine the effectiveness of a play-based intervention designed to support the development of executive functioning in 3-5-year-old children. the intervention is implemented in the day care setting as a part of early childhood education in collaboration with parents and local healthcare and social welfare workers. the study hypothesizes that the intervention as an add-on to normal early childhood education brings added benefits to the development of children's executive functioning in comparison to early childhood education without the add-on.

this cluster-randomized controlled trial examines the effectiveness of a play-based intervention, added as a component to normal early childhood education, in supporting the development of executive functioning in 3-5-year-old children in comparison to early childhood education without such a component. 12 day care centers in finland have been randomized to intervention (n = 6) and control (n = 6) groups. the children in the intervention group will receive the intervention in the spring of 2021, and the children in the control group will be on the wait list and receive the intervention in the fall of 2021 after measurements. in the day care centers belonging to the intervention group, play sessions supporting the development of children's executive functioning will be arranged as a part of normal early childhood education. the pre-selected games target children's executive functions and self-regulatory abilities, e.g. inhibition, attention, working memory and emotion regulation. the first phase of the intervention (6 weeks) includes play sessions for all children as well as a parents' evening. in the second phase (8 weeks), more individualized play sessions are arranged for the children that exhibit difficulties in executive functions after the first phase. also, a parents' group is arranged in this phase, which will expand the daily play activities to homes. day care education personnel and parents fill out questionnaires concerning children's behavior at 4 time points, and the children participating in the second phase (small group activity) will complete two ipad tasks before and after the small group activity. the study takes place in finland.

Eligibility criteria:
inclusion criteria: * children born between 4.6.2015 - 11.1.2018 * for the second phase (small group activity): children must exhibit problems in executive functions (e.g. inattention, hyperactivity, impulsivity) and be considered as potentially benefitting from additional practice as assessed by early childhood educators exclusion criteria: -

Keywords: preschool self-regulation executive function problem behavior training play-based
hospital at home at eol in heme malignancies

Conditions: Hematologic Malignancy

Summary: this study is evaluating an intervention, which the investigators call "optimize end of life (eol) care at home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.

this research study is a single arm pilot feasibility study, which is the first-time investigators are examining this care at home intervention in patients with advanced hematologic malignancies. the research study procedures include screening for eligibility, questionnaires, remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs) and hospital care at home (e.g. providing maximal supportive care to to address and manage patients' symptoms) and structured communications oncology clinicians to optimize end of life care for patients with advanced hematologic malignancies. participants will include 3 groups: 1) enrolled patients with advanced hematologic malignancies receiving the end of life (eol) care at home intervention; 2) caregivers of these patients; and 3) oncology clinicians caring for these patients. participants will be in this research study for approximately six months after consent. it is expected that about 30 patients, 30 caregivers, and 15 oncology clinicians will take part in this research study. medically home company is supporting this research study by providing funding.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosed with relapsed or refractory hematologic malignancy * must be receiving treatment with non-curative intent or supportive care alone based on the intent of chemotherapy as reported in order entry or electronic health record * deemed eligible to receive eol care at home based on the primary oncologist's assessment * able to communicate and respond to questionnaires in english or with the assistance of an interpreter. * residing within 50 miles of mgh. of note, patients requiring supportive transfusions in the oncology clinic will still be eligible to participate. exclusion criteria: * those with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written informed consent as determined by the primary oncologist.

Keywords: hematologic malignancy home care services
the effect of lsvt loud for mandarin-speaking individuals with hypokinetic dysarthria due to parkinson's disease

Conditions: Hypokinetic Dysathria

Summary: a handful of studies have examined the effects of the lee silverman voice treatment (lsvt) loud on hypokinetic dysarthria in english speakers with parkinson's disease (pd). although lsvt loud has been found to be effective on improving these speaker's vocal intensity and increasing their speech intelligibility as well as speech function with phase i evidence, no study has investigated whether mandarin-speaking individuals with dysarthria secondary to pd would benefit from lsvt loud. in the proposed study, speech data of mandarin-speaking individuals with hypokinetic dysarthria before and after speech therapy will be audio recorded and analyzed in order to examine the effects of lsvt loud on the speech function in this population. the same speech data will be played to mandarin listeners in order to investigate the speech intelligibility of this population. it is hypothesized that mandarin-speaking individuals with hypokinetic dysarthria secondary to pd will demonstrate reduced vocal intensity, reduced speech intelligibility and impaired speech function before they receive lsvt loud. they will improve these speech characteristics following speech therapy and will present with short-term maintenance effects.


Eligibility criteria:
inclusion criteria: 1. mandarin-speaking taiwanese 2. hypokinetic dysarthria due to parkinson's disease 3. no other neurodegenerative diseases 4. no cognitive deficits 5. age range 30 years and above exclusion criteria: 1. not able to follow verbal directions, 2. speech characteristics uncommon to parkinson's disease
proof of concept study of cognitive improvement in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to demonstrate that azd3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of azd3480 and to define the optimal dose(s) to be used in future trials.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * outpatient at the time of screening and randomization * stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home) * active cigarette smoking (10 or more cigarettes per day exclusion criteria: * any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder * known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances * impaired vision and/or hearing making cognitive testing difficult

Keywords: schizophrenia cognitive deficits
prostatic artery embolization in advanced prostate cancer

Conditions: Prostate Cancer; Bladder Outlet Obstruction

Summary: this is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

pae has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction. advanced (defined as locally advanced, metastatic or both in this study) pca is frequently associated with both of these conditions. the currently most frequently performed palliative surgical treatment is turp. though performed endoscopically, turp is associated with significant side effects in this setting. pae has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to turp. in addition, there is growing evidence that patients with advanced pca might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). however, recent methods of cytoreductive treatment of pca hold the risk of being highly invasive and are associated with severe side effects. pae might represent a minimally invasive alternative in this setting. therefore, efficacy and safety of pae in patients with advanced prostate cancer is assessed in this pilot-study.

Eligibility criteria:
inclusion criteria * advanced pca (i.e., locally advanced, metastatic, combination of both. this includes t3-4, any t in case of n1 and any t in case of m1a/b/c) * pae is indicated for the treatment of lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding. * ipss at baseline ≥ 8 * witten informed consent exclusion criteria: * curative treatment of pca intended * contraindications for mri * renal impairment (gfr \< 30ml/min) * allergy to i.v. contrast medium * vascular conditions that seem to make successful pae impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to pae.

Keywords: prostate cancer prostate embolization minimally invasive cytoreductive therapy
bladder pressure predicting renal failure in critically ill patients as compared to hemodynamic parameters

Conditions: Acute Heart Failure; Acute Renal Failure

Summary: studies have shown that more than 30% of the overall acute decompensated heart failure (adhf) patients develop renal dysfunction. several studies have tried to find a correlation between hemodynamic parameters (blood pressure , heart rate, central venous pressure cvp) and worsening of renal function in acute decompensated heart failure patients. results showed that there were no correlation between baseline hemodynamics or change in hemodynamics and worsening of renal function. another study showed that intra-abdominal pressure (iap) measuring was a better corollary to renal failure status then measuring cardiovascular hemodynamics using pulmonary artery catheterization in adhf patients.. an increased iap was associated with worse renal function and that level of iap far below abdominal compartment syndrome may adversely affect renal function in patients with adhf.


Eligibility criteria:
inclusion criteria: * any icu(intensive care unit) or ccu(critical care unit) patient older than 18 y. * patient diagnosed on admission with pulmonary edema/chf (fluid in the lungs) - independently from the baseline renal function. * no subject will be accepted to take part in the study unless they are able to sign or if health care proxy signs a consent exclusion criteria: * pregnant women * cognitively impaired patients * age\<18 yrs old * patients diagnosed on admission with ards. * patients admitted with a diagnosis of sepsis ( wbc\> 12000, cxr findings consistent with pneumonia, positive blood cultures on admission, uti)
pregabalin and remifentanil - analgesia and ventilation

Conditions: Pain

Summary: in this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.

pain during cold pressor test (cpt) was scored at all dose levels of remifentanil on a visual analogue scale (vas 0-100 mm). ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (l/min) and expiratory end-tidal carbon dioxide tension (mmhg). side effects such as nausea and sedation were registered.

Eligibility criteria:
inclusion criteria: * healthy volunteers, * \> 18 yrs \< 55 yrs, * negative pregnancy test exclusion criteria: * pregnancy, * nursing, * known heart-, lung- or liver disease, * kidney failure/peptic ulcers, * use of liver enzyme-inducing medications, * known allergy against the medications used in the trial, * use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial, * body weight \> 100 kg or 30% deviation from normal weight, * participant in other studies during the last 2 months, * individuals who do not master norwegian language

Keywords: analgesia acute experimental pain cold pressor test pregabalin remifentanil
a study of avastin (bevacizumab) plus herceptin (trastuzumab) in patients with primary inflammatory her2-positive breast cancer.

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of preoperative treatment with avastin combined with herceptin-based chemotherapy in patients with primary inflammatory her2-positive breast cancer. patients will be treated with a total of 8 cycles of pre-operative chemotherapy + avastin + herceptin. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult females, \>=18 years of age; * inflammatory breast cancer; * her2-positive tumors; * performance status 0-2. exclusion criteria: * metastases; * previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor; * clinically significant cardiovascular disease, or history of thrombotic disorders.