Kornimate/medical-research-clean huggingface dataset:
four different transdermal doses of rotigotine in subjects with idiopathic restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: subjects who meet the diagnosis of idiopathic restless legs syndrome (rls) based on the 4 cardinal clinical features according to the international restless legs syndrome study group (irlssg) are allowed to enroll in this trial. the primary objective of this trial is to demonstrate that rotigotine (spm 936) is efficacious in subjects with idiopathic restless legs syndrome. additional objectives are to investigate the safety and tolerability of rotigotine. subjects will be randomized to receive either placebo, 1.125, 2.25, 4.5, or 6.75mg/day rotigotine in a 1:1:1:1:1 (active:placebo) fashion. approximately 600 subjects will be enrolled in this trial, participating at approximately 60 sites. the maximum duration of the trial is approximately 8 months (consisting of a 4-week titration period, a 6-month maintenance period, a 7-day taper period, and a 30-day safety follow-up period).


Eligibility criteria:
inclusion criteria: * idiopathic restless legs syndrome exclusion criteria: * history of sleep disturbances

Keywords: idiopathic restless leg syndrome
a study to explore correlation between symptoms and signs of polycystic ovarian syndrome (pcos) and risk of over-response to ovarian stimulation

Conditions: Polycystic Ovary Syndrome

Summary: this is a phase iv, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of pcos and examines the utility of 12.5 international units (iu) increment of gonal-f® new pen for individualized controlled ovarian stimulation (icos).


Eligibility criteria:
inclusion criteria: * female subjects aged 20 to 35 years (including both) * subjects undergoing art treatment with long gnrh-a protocol or gnrh-ant protocol + gn + human chorionic gonadotropin (hcg) * subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care exclusion criteria: * subjects undergoing art treatment with mild stimulation protocol * concomitant use of gonal-f® with clomiphene citrate * with an in vitro fertilisation (ivf)/ intracytoplasmic sperm injection (icsi) history of greater than or equal to (\>=) 3 times * known history of poor ovarian response in a previous cos cycle for ivf/icsi, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as antral follicle count (afc) less than (\<) 5 to 7 * presence of confirmed or suspected endometriosis grade iii - iv * presence of unilateral or bilateral hydrosalpinx * using other gn during stimulation period (such as urinary fsh/human menopausal gn, except for recombinant luteinizing hormone (r-lh)) * known history of recurrent miscarriage * any contradiction to gn/gnrh analogues * any major systemic disease that as per investigator's discretion precludes subject for participation in the study * according to the judgment of the investigator, any medical condition or any concomitant * surgery/ medications that would interfere with evaluation of study medications * simultaneous participation in another clinical study

Keywords: polycystic ovary syndrome gonadotropin releasing hormone agonist (gnrh-a) gonal-f assisted reproductive technology
single incision versus conventional laparoscopic appendectomy

Conditions: Appendicitis

Summary: the aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

appendicitis is the most common abdominal emergency. the treatment is surgical and single incision laparoscopic surgery (sils) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * patients with suspected acute appendicitis exclusion criteria: * perforated appendicitis
prehospital minutes count during a stroke.

Conditions: Stroke, Acute

Summary: the ultimate objective is to improve the efficacy of prehospital procedures for patients suffering an acute stroke. increased precision in prehospital selection and a more efficient transport chain will lead to an even more rapid start of treatment and thus benefit patients. the research project has two parts: one part collecting data from medical reports and one study with qualitative in-depth interviews. the project will gather data from various parts of norway and from a university hospital in switzerland for comparison between regions and countries. data will be retrieved through intrahospital and prehospital medical records from various parts of norway (nordland hospital, akershus university hospital and helgeland hospital) and from basel university hospital in switzerland. knowledge of factors associated with delays will be compared for regions in the north and south of norway, as well as abroad. the information obtained will be analysed to identify components in the chain that may be improved as concerns time saving.


Eligibility criteria:
inclusion criteria: • final diagnosis of stroke at discharge from hospital exclusion criteria: • hospital admission later than one week from stroke onset
impact of left atrial appendage closure on physical capacity.

Conditions: Atrial Fibrillation

Summary: closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- it is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or quality of life.

the monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. the trial is planned as a all comers trial.

Eligibility criteria:
inclusion criteria: * patient with a indication for laa closure device implantation exclusion criteria: * inability to perform exercise testing
study comparing regional anesthetic blocks and periarticular infiltration for the management of post-operative pain after direct anterior total hip arthroplasty

Conditions: Degenerative Joint Disease

Summary: to compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. there is a perception that the periarticular injections may not be as effective in controlling post-operative pain. both methods are current standard of care. the investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.


Eligibility criteria:
inclusion criteria: * subject scheduled for direct anterior unilateral total hip replacement * weight ≥ 50 and ≤125 kg * intact neurological exam * cognitively intact with ability to sign consent exclusion criteria: * renal insufficiency with creatinine \> 1.5 mg/dl * allergic to any of the following : ropivacaine, epinephrine, ketorolac, morphine sulfate, nsaids, tylenol, neurontin, morphine, oxycodone or dilaudid. * subject taking regular narcotic medications prior to surgery (20mg/day morphine equivalents for \>7days) * subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management. * subject with contraindication for spinal anesthesia
high-resolution oximetry to diagnose obstructive sleep apnea

Conditions: Sleep Apnea

Summary: the aim of this study was to compare an overnight digital monitoring device (odm) with home sleep apnea testing (hsat) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for polysomnography (psg).

obstructive sleep apnea (osa) is extremely common has prompted the popularization of home sleep test (hst). hst record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. hst has a performance as good as psg among patients with suspected osa and no significant co-morbidities. our study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as overnight digital monitoring (odm) (bilogixtm). we will compare the results of odm with hst performed by apnealink air by resmed®. we have already compared odm to psg with excellent results in a prior study and intend to see the results in uncontrolled environment (home) . population: men and women from the são paulo department of health, who are awaiting examination for diagnosis of osas.we intend to compare the odm with the hst. patients with indication for cpap titration will be excluded. the participants will wear a wireless oximeter (oxistar, biologix sistemas ltda., brazil) with a built-in accelerometer on a finger of the same hand as the hst oximeter and we will compare both methods for diagnosing osa. all hst studies will be scored by 2 independent certified technicians blinded to the odm results. hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. hypopneas will be scored according the acceptable aasm criteria for hypopnea (≥ 4% reduction in spo2). mild, moderate and severe osa will be defined according to the current standards (5 ≤ ahi \<15; 15 ≤ ahi \<30 and ahi ≥30 events/h, respectively).odi results from odm will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. in order to compare with tst-ahi4%, odm will be matched using 4% desaturation criteria (odm-odi4%, respectively).

Eligibility criteria:
inclusion criteria: * adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home exclusion criteria: * patients under treatment for osa

Keywords: sleep apnea home sleep test oximetry
trial evaluating the efficacy of carboplatin in metastatic prostate cancer with gene alterations in the homologous recombination pathway

Conditions: Castration-resistant Prostate Cancer; Metastasis

Summary: the investigators propose a phase ii study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the homologous recombination (hr) pathway. this study may also better characterize the molecular abnormalities of tumors required for the carboplatin response


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded) * tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor dna, or germinal mutation among the list of genes defined in the study * castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone ≤50ng /dl agonist / antagonist of luteinizing hormone-releasing hormone (lhrh) or surgical castration. the patient must agree to continue concomitant lhrh-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration. * patients must have performed at least one line of chemotherapy by taxane in case of castration resistance: * patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance * patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel and cabazitaxel or have a contraindication to discontinue treatment. * patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide) * patients may have been treated with a poly (adp-ribose) polymerase inhibitor (parp) * performance status \<2 * metastatic disease progressive exclusion criteria: * absence of previous treatment with taxane in situation of sensitivity or resistance to castration. * absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment) * no treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment * previous treatment with platinum * symptomatic and untreated central nervous system (cns) metastases. patients with asymptomatic and pre-treated cns metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain mri evaluation at screening and during follow-up.

Keywords: anomaly of the homologous recombination (hr) pathway carboplatin
intramural needle ablation for ventricular tachycardia

Conditions: Recurrent Ventricular Tachycardia

Summary: this is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (rf) catheter ablation. following ablation, patients will be monitored for 6 months. the duration of the study is up to 4 years.

this is an observational prospective cohort study of patients undergoing needle catheter ablation. patients with recurrent sustained or incessant ventricular tachycardia who have recurrent monomorphic ventricular tachycardia that has failed antiarrhythmic drug therapy and prior catheter ablation who are undergoing intramural needle ablation for vt will be offered participation. data will be collected during the procedure and during follow-up. patients will be monitored in hospital for complications and during 6 months follow-up. data collection: baseline data: baseline demographic information and a narrative medical history will be collected on all patients, including documentation of prior cardiac history, and arrhythmia history, as well as prior medications and cardiac procedures. procedural data: details of the procedure including both procedural methods and arrhythmias induced, ablation parameters, needle deployments, recordings and response to procedure. followup data: adverse events will be collected for events which are documented during enrollment and follow-up. during follow-up, hospitalizations will be collected, need for further procedures, implantable defibrillator therapies and procedures will be collected, as well as follow-up echocardiography findings.

Eligibility criteria:
inclusion criteria: * patients undergoing catheter ablation using the needle ablation catheter for ventricular arrhythmias. exclusion criteria: * patient refusal to participate

Keywords: catheter ablation ventricular tachycardia intramural needle catheter
nitric oxide gas inhalation in severe acute respiratory syndrome in covid-19

Conditions: SARS (Severe Acute Respiratory Syndrome); Coronavirus

Summary: severe acute respiratory syndrome (sars-cov2) due to novel coronavirus (2019-ncov) related infection (covid-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. to date, there is no specific treatment available for 2019-ncov. nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ards). in-vitro and clinical evidence indicate that inhaled nitric oxide gas (ino) has also antiviral activity against other strains of coronavirus. the primary aim of this study is to determine whether inhaled no improves oxygenation in patients with hypoxic sars-cov2. this is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation

severe acute respiratory syndrome (sars-cov-2) due to novel coronavirus (2019-ncov) related infection (covid-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. to date, there is no specific treatment available for 2019-ncov. nitric oxide is a selective pulmonary vasodilator gas used as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ards). in has also shown in-vitro and clinical evidence that inhaled nitric oxide gas (ino) has antiviral activity against other strains of coronavirus. the primary aim of this study is to determine whether inhaled no improves oxygenation in patients with hypoxic sars-cov2. this is a multicenter randomized controlled trial with 1:1 individual allocation. patients will be blinded to the treatment. intubated patients admitted to the intensive care unit with confirmed sars-cov-2 infection and severe hypoxemia will be randomized to receive inhalation of no (treatment group) or not (control group). treatment will be stopped when patients are free from hypoxemia for more than 24 hours.

Eligibility criteria:
inclusion criteria: (1) adult patients, \>/= 18 year-old; (2) patients admitted to the icu; (3) patients who are intubated and mechanically ventilated; (4) confirmed diagnosis of sars-cov2 by positive rt-pcr. exclusion criteria: (1) patients intubated for more than 72 hours from initiation of the treatment gas; (2) subjects enrolled in another interventional research study; (3) physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely; (4) subjects with past medical history of lung malignancy or pneumonectomy or lung transplant; (5) subjects receiving a tidal volume \ 50%; (12) subjects not fully committed to full support at the time of enrollment; (13) subject receiving inhaled nitric oxide gas prior to enrollment; (14) subject's hospital admission unrelated to covid-19.
role of the gut microbiome in complex regional pain syndrome

Conditions: Complex Regional Pain Syndromes

Summary: the objective of this prospective, observational study is to determine the association between the composition of the gut microbiota and the severity and persistence of complex regional pain syndrome symptoms (study a). the objective of study b, a longitudinal study of microbiota biomarkers of patients with newly diagnosed crps is to determine if the researchers can predict which patients are more likely to recover compared to those who do not. a secondary objective of both studies is to examine cognitive flexibility in relation to outcomes (study a and b).


Eligibility criteria:
study a: cross-sectional study inclusion criteria, cases: * adults over the age of 18 * current (\ 1 year) diagnosis of complex regional pain syndrome by the budapest criteria * english as primary language * able to consent inclusion criteria, controls * adults over age of 18 * cohabitant of person with current or former diagnosis of crps study b: longitudinal study inclusion criteria, cases: * adults over the age of 18 * recent diagnosis (\<6 months) of complex regional pain syndrome by the budapest criteria * english as primary language * able to consent inclusion criteria, controls * adults over age of 18 * cohabitant of person with diagnosis of crps study a and b: exclusion criteria, cases and controls: * unwilling to participate in the study * lives alone * current use of probiotics and unwilling to stop for 1 week prior to stool sample * pregnant or lactating * vegan diet
neural mechanisms of cognitive assessment and rehabilitation for cognitive decline

Conditions: Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD); Aging; Healthy

Summary: this study investigates the neural mechanisms of cognitive function decline, cognitive assessment methods for subjects with mild cognitive dysfunction (mild cognitive impairment, mci, or cognitive decline milder than mci), and the approaches used to improve and restore cognitive function.

cognitive assessment tools are used to assess cognitive function of subjects in different cities. functional and structural mri and eeg are applied to investigate the neural mechanisms of cognitive function decline and effects of methods to improve and restore cognitive function.

Eligibility criteria:
inclusion criteria: * adults being able to walk at least a block, and * adults with subjective cognitive decline (scd), or * adults with mild cognitive impairment (mci), or * adults with normal cognitive function exclusion criteria: * clinical diagnosis of dementia * adults who cannot follow the protocal
multiple doses of anti-nogo a in relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study will investigate an experimental new drug, gsk1223249 in patients diagnosed with relapsing forms of multiple sclerosis. the study will specifically investigate safety (vital signs like heart rate, blood pressure, magnetic resonance imaging (mri), and other markers of health from blood samples), tolerability (any side effects that occur, if any), and pharmacokinetics (how the body processes the drug and how long the drug stays in the blood, and in cerebro-spinal fluid). the study will also investigate if patients' own immune system interacts with gsk1223249.

this study will be a randomised, placebo-controlled, single-blind (investigator and subject), single and repeat ascending dose protocol, in multiple sclerosis patients. the study is designed to evaluate the safety, tolerability, pharmacokinetics, and any potential for immunogenicity of gsk1223249 (a monoclonal antibody raised against nogo-a), given intravenously in multiple sclerosis patients. the study will also evaluate exploratory endpoints including para-clinical activity via magnetic resonance imaging, cerebrospinal fluid pharmacokinetics, and effect of repeat dose administration of gsk1223249 on disability. furthermore ms symptoms, such as relapses and individual symptom severity will be closely monitored.

Eligibility criteria:
inclusion criteria: * diagnosed with a relapsing form of ms . * using one of the following ongoing ms treatment strategies, defined as 1. currently receiving beta-interferon/copaxone for treatment of ms and have been receiving the current course of therapy for 3 or more months prior to screening, or 2. not currently receiving disease modifying therapies for treatment of ms, and has not received such therapies for at least 3 months prior to screening. * demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen * expanded disability status scale (edss) score ≤6.0 at either the screening or baseline visit. * male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent. * body weight equal to or greater than: 50 kilogrammes exclusion criteria: * complications/history of other diseases that may impact on safety of patients enroling into the study. * liver function test outside normal range for patient population * treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening * treatment in the past 6 months with any of the following agents: fingolimod (gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants. * history of anaphilaxis to protein based therapeutics or mono-clonal antibodies. * positive result for hapatitis b, hiv, and/or drugs of abuse, or excessive alcohol consumption. * not able to undergo mri scanning safely, or gadolinium (contrast enhancing agents) during mri. * other significant infections e.g. tuberculosis.

Keywords: multiple sclerosis, secondary-progressive with relapses