Kornimate/medical-research-clean huggingface dataset:
somatuline predictive factors in acromegaly and net

Conditions: Acromegaly; Neuroendocrine Tumours

Summary: the aim of the study is to identify predictive factors for the response to lanreotide treatment in acromegaly as well as in neuroendocrine tumours.


Eligibility criteria:
inclusion criteria: * written informed consent (also mandatory in case of retrospective documentation of subject data) * diagnosis of acromegaly or net with the intention to be treated with atg or already on treatment with atg exclusion criteria: * the subject has already been included in this study * participation in an interventional trial
intensive pharmacovigilance program for elaprase (shp ela-701)

Conditions: Hunter Syndrome

Summary: the purpose of this non-interventional, observational study which is conducted in mexico is to evaluate the safety profile of elaprase (idulsurfase) in participants with hunter syndrome (mucopolysaccharydosis ii) being treated with elaprase.


Eligibility criteria:
inclusion criteria: * participants of both genders * participants to whom idursulfase (elaprase) has been prescribed * participants with hunter syndrome * participants accepting to participate * participants signing the informed consent and privacy notice for handling personal information in: the program contigo shire (training, diagnosis, family trees) and the intensive pharmacovigilance study for elaprase. if the participant is unable to provide legal consent (example: under legal age), the participant's legal guardian must provide consent exclusion criteria: * participants withdrawing their consent to continue participating in the non-intervention intensive pharmacovigilance study for elaprase * known hypersensitivity or presence of any contraindication to elaprase that cannot be controlled by pre-medication * a physical condition that would not permit intravenous administration of enzyme replacement therapy (ert) * participants enrolled in shire sponsored elaprase registry or any other shire sponsored elaprase study

Keywords: hunter syndrome (mucopolysaccharydosis ii)
effects of ultrasound therapy on cartilage healing in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine the effects of low intensity ultrasound therapy over the cartilage morphology (thickness and volume) of patients with mild or moderate knee osteoarthritis.

knee osteoarthritis (oa) negatively influences the healthy aging process of the population. until today, there are no interventions that have proved effective for enhancing the cartilage regeneration of these patients. the use of low intensity ultrasound (lius) therapy has demonstrated promising effects on cartilage regeneration in vitro and in vivo. the aim of this study was to assess the effects of 24 sessions of lius on the cartilage volume and thickness of patients with grades 1 and 2 (medial joint space narrowing oarsi atlas 2007) knee osteoarthritis (oa).

Eligibility criteria:
inclusion criteria: * adults ≥ 45 years old. * fulfillment of the clinical / radiological diagnostic criteria proposed by altman, et al. for knee osteoarthritis. * medial tibiofemoral compartment joint space narrowing grades 1 or 2 according to the oarsi atlas guide. * ability to read and understand english questionnaires and follow instructions. exclusion criteria: * presence of metabolic related arthritis (calcium crystal deposition, hemochromatosis, acromegaly) * arthritis related to trauma (major joint trauma, joint surgery) * presence of inflammatory disorders (rheumatoid arthritis, ankylosing spondylitis, septic arthritis) * previous surgical knee intervention * intraarticular injection of the knee in the previous 6 months. * presence of an unexpected traumatic episode in the affected knee (s) during the course of the study. * any contraindication for x ray or peripheral mri study.

Keywords: ultrasound therapy knee cartilage thickness knee cartilage volume mild knee osteoarthritis moderate knee osteoarthritis
a study to evaluate the efficacy and safety of bimekizumab compared to ustekinumab in children and adolescents from 6 years to less than 18 years of age with moderate to severe plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: the primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (pso).


Eligibility criteria:
inclusion criteria: * study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation * study participant has had a diagnosis of moderate to severe plaque psoriasis (pso) for at least 3 months prior to the screening visit * study participant meets the following at both the screening and baseline visits: 1. body surface area (bsa) affected by pso ≥10% 2. . investigator's global assessment (iga) score ≥3 (on a scale from 0 to 4) 3. . psoriasis area and severity index (pasi) score ≥12 or pasi score ≥10 plus at least 1 of the following: i) clinically relevant facial involvement ii) clinically relevant genital involvement iii) clinically relevant hand and foot involvement * study participant is a candidate for systemic pso therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling * study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at screening exclusion criteria: * primary failure (no response within 12 weeks) to 1 or more interleukin-17 (il-17) biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) or more than 1 biologic response modifier other than an il-17 * study participant has a presence of guttate, inverse, pustular, or erythrodermic pso or other dermatological condition that may impact the clinical assessment of pso * study participant has a history of inflammatory bowel disease (ibd) or symptoms suggestive of ibd * history of active tuberculosis unless successfully treated, latent tb unless prophylactically treated * study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections) * study participant has previously received bimekizumab * study participant has previously received ustekinumab * study participant has received drugs outside the specified timeframes relative to the baseline visit or receives prohibited concomitant treatments * study participant has the presence of active suicidal ideation, or positive suicide behavior * study participant diagnosed with severe depression in the past 6 months (prior to screening) should be excluded * study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study

Keywords: bimekizumab bkz ustekinumab paediatric study participants children adolescents psoriasis pso plaque psoriasis paediatric psoriasis pediatric psoriasis
aripiprazole treatment of the prodrome

Conditions: Prodromal Schizophrenia; Prodromal Psychosis

Summary: the rap program is conducting a research study of the antipsychotic medication aripiprazole. this drug has been approved for treating symptoms associated with schizophrenia and is associated with fewer side effects. this study will explore how well aripiprazole treats symptoms of early-onset psychotic disorders as well as symptoms that may indicate risk for such disorders, including unusual thoughts, suspiciousness, perceptual abnormalities, social isolation, and sudden changes in functioning.

during the 12-week study, eligible patients are seen 7-9 times by research raters and psychiatrists. these visits include side effect monitoring, scheduled medication increases, and ratings designed to measure subtle improvement of symptoms. monthly blood and urine samples are collected for safety and substance abuse monitoring, and neuropsychological testing is conducted at the first and last appointments. participants are compensated for their participation and receive medication and study-related visits at no cost during the trial. depending on their level of response to the medication, participants may also be eligible for a 3-month extension phase.

Eligibility criteria:
inclusion criteria: * you are between the ages of 13 and 22. * you are english-speaking. * you have a diagnosed psychotic disorder, including: schizophrenia, schizophreniform disorder, schizoaffective disorder, or other psychotic disorder * or - * you are experiencing one or more pre-psychotic symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences. * you meet additional rap criteria assessed during screening and interview. exclusion criteria: * you have a diagnosis of bipolar disorder or major depression with psychotic features. * you have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain. * you have past or current substance dependence. * you are currently taking aripiprazole. * you have taken aripiprazole in the past. * you are currently taking and responding well to another medication.

Keywords: early intervention social functioning role functioning cognition
effect of intense vs. standard hypertension management on nighttime blood pressure - an ancillary study to sprint

Conditions: Hypertension

Summary: hypertension is a major risk factor for cardiovascular and renal disease, and a leading cause of premature mortality worldwide. early hypertension studies showed that treating elevated blood pressure (bp) reduces patients' risk of cardiovascular disease and all-cause mortality. in subsequent research, patients achieved greater improvement in cardiovascular outcomes when their treatment was aimed at a moderate systolic bp target (\<150mmhg) than at higher targets. although observational data suggest that even lower bp targets may be beneficial, this has not been seen in randomized trials; instead, "intense" treatment of hypertension (i.e., to a target systolic bp \<120mmhg) was found to have no effect on participants' risk for renal disease, cardiovascular disease, or all-cause mortality. one potential explanation for this apparent lack of benefit of intense bp targets is that the study protocols targeted reductions in clinic bp rather than ambulatory bp. ambulatory bp monitoring (abpm) allows for assessment of bp throughout the day and night. of all the bp measurements, nighttime systolic bp appears to be the best predictor of cardiovascular disease and all-cause mortality. because recent trials assessing intense bp targets did not include ambulatory bp measurements, the effect of intensive treatment on nighttime bp is largely unknown. to address this important gap in knowledge, we will conduct abpm in 600 participants as part of an ancillary study to the ongoing systolic blood pressure intervention trial (sprint). the goal of the ancillary study is to evaluate the effect of intensive vs. standard clinic based bp targets on nighttime bp (primary outcome), as well as night/day bp ratio, timing of peak bp, 24hr bp, and bp variability (secondary outcomes). the sprint trial includes approximately 9250 participants at high risk for cardiovascular disease. the investigators hypothesize that intense targeting of clinic systolic bp does not lower nighttime systolic bp compared to a standard target.


Eligibility criteria:
inclusion criteria: * eligible and enrolled in sprint at the 27 month follow up visit * able and willing to provide informed consent exclusion criteria: * arm circumference \>50cm * shift worker or work regularly at night * history of breast cancer requiring mastectomy * end-stage renal disease

Keywords: hypertension nighttime blood pressure
safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of bi 201335 as softgel capsule in naive hepatitis c virus (hcv) patients

Conditions: Hepatitis C; Pharmacokinetics

Summary: the current standard of care (soc) for chronic hcv infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications. a number of compounds with direct activity are currently under clinical development, incl. bi 201335. bi 201335 works by preventing the hepatitis c virus from replicating by binding to the hcv protease (enzyme). the main purpose of this clinical trial with bi 201335 is to see how well bi 201335 works and how safe bi 201335 is to use daily in combination with pegifn and rbv in hcv infected patients


Eligibility criteria:
inclusion criteria: * chronic hcv genotype-1; * high viral load exclusion criteria: * mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening * previous treatment with protease inhibitor
cognitive impairment and imaging correlates in end stage renal disease

Conditions: End Stage Renal Disease

Summary: this is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

cognitive impairment is very common in patients with end stage renal disease (esrd). it exact mechanisms are not clear, but patients with esrd have more cerebral white matter changes. several studies have shown that cognitive function improves post-transplant, indicating that there may be some reversibility in the process. this study will examine the correlation between cognitive impairment and structural brain changes before and after renal transplantation. we will also study the correlation of cognitive function with serum inflammatory markers before and after transplant. these results will be compared to aged matched healthy controls without kidney disease.

Eligibility criteria:
inclusion criteria: * pre-transplant esrd patients who are listed for renal transplantation * able to sign pre-transplant consent on their own will * have english as their native language exclusion criteria: * current use of antipsychotics or anti-epileptics * inability to read or write which will limit their ability to perform the cognitive tests * claustrophobia or inability to get mri for other reasons * unable to sign consent
benzodiazepine study for the treatment of seizure clusters in a third level mexican neurological center

Conditions: Cluster Seizure

Summary: the aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in mexico city.

this is an open label, randomized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center. primary objective: to evaluate the clinical impact of the use of buccal midazolam as a treatment of seizure clusters in comparison with orodispersable clonazepam vs usual care. secondary objective: to identify patients that present seizure clusters and risk factors associated with the diagnosis. to evaluate the quality of life after drug administration, to evaluate the adverse events associated with the medications. to establish seizure recurrence and mortality in 6 months' follow up.

Eligibility criteria:
inclusion criteria: * at least age of 18 * patient available for follow-up * previous diagnosis of epilepsy * patient meets criteria for seizure clusters (3 or more seizures in a period of 24 hours) exclusion criteria: * risk factors for epilepsy have been identified and uncontrolled. * younger than 18 years olf * follow- up in another healthcare unit * no previous epilepsy diagnosis * adequate control of epilepsy * patient meets criteria for clinical or electrographic status epilepticus.

Keywords: seizure cluster epilepsy rescue medication benzodiazepines
study of ianalumab versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (itp)

Conditions: Primary Immune Thrombocytopenia (ITP)

Summary: the purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 g/l in adult participants with primary itp.

this is a multi-center, randomized, double-blind phase 3 study to assess the efficacy and safety of two different doses of ianalumab compared to placebo in adults with primary itp (platelets count \<30 g/l) who require first-line standard-of-care corticosteroids. after completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with standard of care corticosteroids). after the treatment period, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how they respond to the study treatment.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to participation in the study. * male or female participants aged 18 years and older on the day of signing informed consent * primary itp diagnosed within 3 months before initiating first-line itp therapy (corticosteroids, ivig) * platelet count below 30 g/l before starting any first-line itp therapy (corticosteroids, ivig) * response (platelet count \>=50 g/l) to corticosteroids (+/- ivig) at any time prior to randomization. note: platelet count measured within 7 days of platelet transfusion will not be considered as response. key exclusion criteria: * evans syndrome or any other cytopenia (patients with low grade anemia related to bleeding or iron deficiency are eligible) * current life-threatening bleeding * previous itp treatment, including splenectomy, except for corticosteroids and/or ivig initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or ivig given prior to confirmed diagnosis of primary itp . * prior use of b-cell depleting therapy (e.g., rituximab). * absolute neutrophil count below 1.0 g/l at randomization * participants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid other protocol-defined inclusion/exclusion may apply.

Keywords: primary immune thrombocytopenia (itp) ianalumab vay736 b-cell depletion b-cell activating factor receptor (baff-r) blockade
diffuse optical monitoring with inhaled nitric oxide

Conditions: Stroke

Summary: this study is a non-randomized, phase 2 clinical trial designed to measure the cerebral blood flow (cbf) response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects. the monitoring is a 35 minute session during which cerebral hemodynamics will be monitored with both diffuse correlation spectroscopy (dcs) and transcranial doppler ultrasonography (tcd) while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide (no)/nitrogen dioxide (no2) concentration, are continuously monitored.


Eligibility criteria:
inclusion criteria: stroke patients: 1. age greater than 18 2. acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain 3. study can be initiated within 72 hours of stroke symptom onset 3. ability and willingness to sign informed consent healthy subjects: 1. age greater than 18 2. ability and willingness to sign informed consent exclusion criteria: stroke subjects: 1. history of prior stroke or transient ischemic attack 2. known cerebrovascular abnormality 3. history of congestive heart failure 4. presence of pneumonia or active pulmonary infection 5. current use of any no donor medication (sodium nitroprusside or nitroglycerin) 6. age less than 18 years 7. skull defect that would interfere with cbf monitoring 8. pregnancy 9. structural brain lesion 10. prior neurosurgical procedure 11. history of psychiatric disease 12. any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study healthy subjects: 1. history of any neurological disease 2. history of stroke or transient ischemic attack 3. known cerebrovascular abnormality 4. history of congestive heart failure 5. history of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease 6. presence of pneumonia or active pulmonary infection 7. current use of any no donor medication (sodium nitroprusside or nitroglycerin) 8. age less than 18 years 9. skull defect that would interfere with cbf monitoring 10. pregnancy (urine or blood tests will not be performed) 11. structural brain lesion 12. prior neurosurgical procedure 13. history of psychiatric disease 14. any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study 15. cognitive impairment
resistance exercise in children with post-operative congenital diaphragmatic hernia

Conditions: Hernias, Diaphragmatic, Congenital

Summary: congenital diaphragmatic hernia (cdh) is a life-threatening condition with long-term complications including respiratory tract infections, respiratory muscle weakness, and abnormal lung functions. this study, therefore, has been designed to ascertain the effect of chest resistance exercise and chest expansion exercise on respiratory muscle strength, lung function, and chest mobility in children with post-operative cdh.

with the advances in surgical and neonatal treatment, the survival rates in children with cdh have been improved in the last decades. the surviving children may suffer from long-term complications such as impairments in lung growth (lung hypoplasia), cardiovascular disorders, pulmonary hypertension, gastrointestinal problems, and recurrent occurrence of lower respiratory tract infection. one of the physical therapy techniques used to treat chest disorders via encouraging the normal alignment of respiratory muscles with respiratory rhythm is chest resistance exercise through applying resistance to the sternal and coastal areas .

Eligibility criteria:
inclusion criteria: * ages between 10 and 14 years. * the bmi between 20 and 25 kg/m2. the children were considered as high risky cdh as they developed respiratory distress in the first days of their life. * cdh was corrected surgically immediately after birth. * children are still in following upstate in pediatric and physical therapy departments. exclusion criteria: * physical disability. * diaphragmatic eventration. * unable to perform all tests or procedures. * children with cardiac anomalies
propofol effects on mitral valve annular velocity

Conditions: Valvular Heart Disease; Coronary Artery Disease

Summary: the purpose of this study is primarily to determine the effects of propofol at different concentration on the mitral valve annulus by using tissue doppler imaging

the purpose of this study is to evaluate the effects of different concentration of propofol on patients who are undergoing cardiac surgery. the patients will receive infusion remifentanil 0.5mcg/kg/min with different target-site propofol concentration namely 1.0ng/ml, 2.0ng/ml and 3.0ng/ml. tissue doppler imaging by transesophageal echocardiography will be done to assess the changes in cardiac function.

Eligibility criteria:
inclusion criteria: patients undergoing cardiac surgery exclusion criteria: low ejection fraction \< 50% on transthoracic echocardiography atrial fibrillation pacemaker pericardial and infiltrative myocardial disease mitral annular calcification, surgical rings, prosthetic mitral valve lateral left ventricular wall motion abnormality oesophageal abnormality history of extensive radiation to the mediastinum upper gastrointestinal bleeding